st. jude stimulator
 

Has anyone had any luck with a st. jude stimulator?

Hi Alt,

Please do your own extensive research regarding Spinal Cord Stimulators of any kind and CRPS.

Please see below for a start.

http://neurotalk.psychcentral.com/sh...timulator+CRPS

Ballerina - please do not include me in your list of those who have not had success with the SCS. Yes, I have had a revision on one of mine, but that is not a failure or spread, or necessarily a bad thing. I have two stimulators implanted (cervical and thoracic). I consider the fact that I can use my hands and my pain is reduced a success. The other is still a work in progress. It doesn't work to the fullest amount yet, but my pain is reduced there as well...also not a failure.
Thank you,
Nanc

Yes, I have two St Jude stimulators implanted. As you have probably seen in my posts, we are working on the thoracic one. I wish they had started with the paddle leads instead of the percutaneous ones there...would've saved some trouble since they tend to migrate. No problems with the cervical one at all!

I wish I would have thought more carefully about the battery placement.

I have three reps in this area and they are all great to work with.

Do not regret my decision in getting it.
Nanc

Nanc,

Thanks for your input. I am scheduled for a trial in the latter part of February, after a failed trial last February and I ended up on a rollabout. After the last one, I had extreme back pain for 3 days of my trial then on the 4th or 5 th day needed a readjustment. Needless to say, out of 7 days I only got a half way decent pulse for 2 days.

Fyi
 

Sanctions by the FDA within the last eighteen months regarding St. Jude Spinal Cord Stimulators

Department of Health and Human Services Public Health Service
Food and Drug Administration

June 26, 2009

Ref: 2009-DAL-WL-15

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Daniel J. Starks
President and Chief Executive Officer
Saint Jude Medical, Inc.
One Lillehei Plaza
Saint Paul, Minnesota 55117
Dear Mr. Starks:
During a March 5 through April 6, 2009, inspection of your company, Advanced Neuromodulation Systems (ANS), Inc. which is also doing business as Saint Jude Neuromodulation Systems, Inc., located at 6901 Preston Road, Plano, Texas 75024 investigators from the United States Food and Drug Administration (FDA or Agency) determined that your company manufactures and distributes a spinal cord stimulation system that consists of a rechargeable or a primary cell implantable pulse generator (IPG), an external multiprogram trial stimulator (MTS), implantable leads, an external patient programmer, and an external charging system. This spinal cord stimulation system is indicated for the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are medical devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act, 21 U.S.C. § 351 (h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
At the conclusion of the inspection, the investigators issued to Mr. Christopher G. Chavez, President of Advanced Neuromodulation Systems, Inc., the Form FDA 483 (List of lnspectional Observations). We received your company's response with attachments, dated April 13, 2009, to the observations noted on the Form FDA 483 (List of lnspectional Observations). The Agency acknowledges your commitments to take all necessary actions to ensure ANS' compliance with the Quality System regulation and provide quarterly updates until all corrective actions have been completed.
Pages 10 and 12 of your response discussed your company's action from March to December 2008 to retrieve (remove) from the field individual defective MTS trial stimulators due to a known design problem (a software defect in CAPA 62729 and related CAPA 67300, and a hardware defect in CAPA 53116) and replace them with new ones. Defective MTS trial stimulators can cause loss of stimulation or the inability of the devices to complete the trial implants. Page 14 of your response and CAPA 62730 (attached as Attachment 15 to your response) discussed your company's action of sending marketing update No. 5022, dated May 15, 2007, to your field representatives, shipping replacement chargers to patients, and redesigning the charging systems of the IPG to correct no stimulation, communication errors between the implant IPGs and their charging systems, and corrupt program. In particular, the May 15, 2007 marketing update discussed unequal electric field strengths between the two sides of the charging antenna of the charging systems, and CAPA 62730 discussed low antenna voltages of the returned chargers and possible IPG explants if the replacement charger does not address the patient's concern. To determine whether or not product corrections or removals must be reported to the Agency as a reportable product recall under 21 C.F.R. §§ 806.10 and 806.20, we encourage your company to contact our Recall Coordinator at 214-253-5222.
While initiating CAPAs to correct the various quality issues described in the company's System Performance Reports and the FDA 483 is a positive step, these CAPAs did not address the gaps in your company's design and production controls that caused the quality problems in the first place.
The Agency is not satisfied with your response. Your company must adequately address the violations identified below, perform and document the results of your extended field monitoring in order to verify that the recent design changes will effectively correct past and existing quality issues of your devices and prevent their recurrence, and conduct a comprehensive review and audit of the manufacturing operations at ANS in Plano, Texas, and (b)(4) and their suppliers in order to identify and correct all potential GMP deviations, and prevent distribution of nonconforming/defective devices.
The Agency expects your corporate office to work closely with the ANS manufacturing facilities and their suppliers in order to (a) significantly improve the quality of your devices, (b) timely and effectively implement permanent and substantial actions to correct and prevent potentially systemic noncompliant issues, and (c) provide resources as needed and oversight to achieve all corrective actions.
The Agency addresses your response below, in relation to the noted violations. Your response to this warning letter is required. The Agency will conduct follow-up inspections to assure that your firm's corrections are adequate.
These violations include, but are not limited to, the following:
Quality System Violations
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 C.F.R. § 820.100(a), and failure to document the results of corrective and preventive action activities, as required by 21 C.F.R. § 820.100(b). See FDA 483 Items 1 and 2. Specifically,
At the time of the inspection, your company has not completed, implemented, or verified the effectiveness of at least (18) corrective and preventive actions (CAPAs) that were initiated to correct various quality issues with the MTS trial stimulators, implant Eon IPG generators, charging systems, and patient programmers as reported on pages 33 through 38 of your company's System Performance Report, dated March 19,2009. For example:
a. CAPA 62729 and related CAPA 67300, which were initiated on September 2, 2008, and November 17, 2008, respectively, identified "Design" as the root cause of the upward trend of complaints associated with the MTS trial stimulators. These CAPAs discussed a software upgrade to correct a timing problem causing system error codes (b)(4) and (b)(4) or loss of stimulation. The completion date for these CAPAs was extended until September 30, 2009. Your response stated that the company now completed both CAPAs in April 2009.
b. CAPA 53116, which was initiated on February 15, 2008, also identified "Design" as the root cause of the upward trend of complaints associated with the MTS trial stimulators. This CAPA discussed the design defect in the PCB (b)(4) causing the inability of the device to complete trial implants (loss stimulation). The completion date for this CAPA was extended until August 1, 2009. Your response stated that the company now completed this CAPA in April 2009.
c. CAPA 62730, which was initiated on September 2, 2008, identified "Design Requirements" as the root cause of the upward trend of complaints associated with the charging systems of the implant IPGs.This CAPA discussed the test results of low antenna voltages. a design defect that caused communication errors between the charging systems and the implant IPG devices, corrupt program, and no stimulation. The completion date for this CAPA was extended until May 1, 2009.
d. CAPA 45664, which was initially opened on May 23, 2006, closed, and then reopened on August 20, 2007, identified the (b)(4) auto test failures during production. Your company has not been able to determine the root cause of why the (b)(4) values of the (50) IPG implant generators were reset during production and some IPGs were reset during the implant procedure. The completion date for this CAPA was extended until April 30, 2009, for further analysis.
The Agency is not satisfied with your response. At the time you submitted your response, CAPA 62730 (charging system) was still in process and will continue to be monitored for field performance, and CAPA 45664 had not identified a root cause in order to implement the recommended software upgrade. Your company must perform extended field monitoring (trend analysis) of all sources of quality data, including user complaints/reports, evaluates the data, and documents your evaluation to prove that the design changes or production changes described in the CAPAs will in fact correct the quality problems and will not introduce adverse problems.
2. Failure to investigate the cause of nonconformities relating to product, processes, and the quality system, as required by 21 C.F.R. § 820.100(a)(2). See FDA 483 Item 3. Specifically,
CAPA 45664, initiation dated August 20, 2007, documented an unresolved issue with the Eon Implantable Pulse Generators (IPG) causing at least 50 devices to be reset during production and some devices to be reset during implant. On May 24, 2006 engineering at ANS Texas requested testing of all EON IPGs received from (b)(4) to determine the root cause for the nonconformities. Your company denied this request without documenting any explanation in CAPA 45664 and failed to determine the root cause of the device reset problem. Subtask 94527 of this CAPA, opened on August 20, 2007, updated on August 25, 2008, and extended to April 30, 2009 for further analysis, stated that "the software of the IPG will be updated to not clear the calibration of the IPG upon reset." Your company failed to implement this action as of the time of the inspection.
The Agency is not satisfied with your response. Your response stated that the initial assessment in CAPA 45664 was incorrect and will be changed to reflect that "this was an in-process yield issue only." Your response stated that your company had seen approximately (50) auto test failures during production out of the (b)(4) units produced and that your company had received (4) IPG devices returned from the users that had the (b)(4) reset, and that your firm had investigated possible root causes but to date had not been able to confirm the root cause of this issue in order to update the Eon lPG's software.
Your response has not explained the differences in the software and hardware of the auto test equipment being used at (b)(4) and ANS Texas and whether the auto tests at both facilities have been properly developed and validated under 21 C.F.R. §§§ 820.30(f) [design verification], 820.30(i) [design changes], and 820.70(b) [production and process changes] in order to provide consistent and reliable test results and to determine if there was a problem with the Eon IPG design and/or their auto tests.
3. Failure to establish and maintain adequate procedures for validating the device design in order to ensure that the devices conform to defined user needs and intended uses. The design validation must include testing of production units under actual or simulated use conditions, and risk analysis, where appropriate, and the design validation results must be documented, as required by 21 C.F.R. § 820.30(g). See FDA 483 Item 6. Specifically,
a. CAPA 45664, initiation dated August 20,2007, documented an unresolved issue with the Eon Implantable Pulse Generators (IPG) causing some of the devices to reset. This CAPA has been opened, closed, and reopened since May 23, 2006 and the due date of April 30, 2009 for was extended further analysis. Your CAPA documented that it did not fully understand the cause of this failure mode and did not have the means to correct the devices in the field and provided a risk assessment of "since the outcome is an explant only, there have been no additional or changed hazards associated with these failures." The Agency is not satisfied with your response. Your response stated that the (b)(4) is used for impedance measurement on the lead during the implant procedure only and that if there was a problem, this would occur prior to implant of the IPG and would necessitate the ex-vivo replacement of the IPG only. Your response then concluded that the devices meet the user needs and intended use since no explant would be required (b) (4) were to reset. In our view, failure of a device to perform a correct lead impedance measurement, thus prolonging or stopping a medical procedure, may prevent it from meeting the needs of the user and patient.
b. Your company did not ensure that its design verification and validation process detected design discrepancies with (b)(1) the (b)(4) printed circuit board (PCB) of the MTS trial stimulators using the (b)(4) components that later caused loss of stimulation, and therefore, failure to complete trial implants, and (b)(2) a timing problem in the (b)(4) chips of the MTS trial stimulators that caused memory error codes or data corruption that in turn caused loss of stimulation. These design discrepancies caused an uptrend of user complaints as reported in your company's System Performance Report, dated February 12, 2009, the redesign of the PCB (CAPA 53116, initiation dated February 15, 2009 and a software design change to fix a software error in the (b) (4) timing (CAPA 62729, initiation dated September 2, 2008).
The Agency is not satisfied with your response. Your response stated that the timing problem was also addressed in CAPA 53116, which discussed the redesign of the PCB using (b)(4) components. Your Engineering Test Report 68-0459 (Attachment 10 of your response) did not address any hardware PCB issues in the MTS devices.
The effectiveness of the corrective actions can not be confirmed until your company performs extended filed monitoring (trend analysis) of all sources of quality data, including user complaints/reports, evaluates the data, and documents your evaluation to prove that the design changes will in fact correct the described quality problems and will not adversely affect the devices. Please also clarify if the (b)(4) timing problem was due to both software defect (CAPA 62729 and 67300) and hardware defect (CAPA 53116).
4. Failure to establish adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria and that acceptance activities are documented and reviewed prior to releasing the devices for distribution, as required by 21 C.F.R. §§ 820.80(d) and 820.80(e). See FDA 483 Item 7. Specifically,
a. The finished device testing used at both (b)(4) and ANS Texas failed to adequately test the MTS trial stimulators in order to detect malfunctions in the (b)(4) PCB (CAPA 53116) and a timing problem (CAPA 62729 and 67300), and therefore, prevent distribution of the nonconforming/defective devices and their upward trend of complaints. For example, your company's meeting minutes, dated September 12, 2008, attached to CAPA 62729 acknowledged that several MTS trial stimulators passed internal testing but failed "out-of-box" in the field. The inspection documented that your company received at least eighty four (84) complaints between January 1, 2009 and March 13, 2009, and that thirty-nine (39) of them were associated with diagnostic error codes.
The Agency is not satisfied with your response. Your response stated that your company had instituted additional control measures on October 23, 2008 to prevent "out-of-box" failures, but did not explain the specifics of these measures. You further stated that the "design" was updated [upgraded software and redesigned PCB] to eliminate these occurrences through CAPA 62729 and 53116. The effectiveness of these corrective actions can not be verified until your company completes and documents the results of its extended field monitoring.
b. The finished device testing used at ANS Texas failed to adequately test the charging systems of the implant IPGs in order to detect malfunctions with the charging systems, and therefore, prevent distribution of the nonconforming/defective charging systems and their upward trend of complaints. Your company's meeting minutes, dated September 3 and 8, 2008, attached to CAPA 62730 acknowledged that there were eighty five (85) instances where charging systems returned from their users to your company passed testing but their antennas were later found failing. Defect codes in your company's (b)(4) data base indicated (119) antennas had "low voltages" and (67) antennas had "short."
The Agency is not satisfied with your response. Your response stated that CAPA 62730 was opened to address this issue and your company subsequently performed design modifications to release the newer charger models 3717, 3718, and 3721. The effectiveness of these corrective actions cannot be verified until your company completes and documents the results of its extended field monitoring.
5. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all the requirements of 21 C.F.R § 820.198 are met. See FDA 483 Item 8.
Specifically, your company has not timely identified and entered product defect codes for (1179) complaints, and reason codes for (471) complaints received from June 2008 through February 2009. Of the (1179) complaints, (388) complaints were associated with the "Programmers," (454) complaints were associated with the "Chargers," and (115) complaints were associated with the "IPGs." See page 88 and 93 of your System Performance Report, dated March 19, 2009. The System Performance Report described their complaint status as "blank - still in process... " or "In process."
The Agency is not satisfied with your response. Your response stated that you will revise your complaint handling procedure to require the product defect and reason codes be entered into your company's database after completion of the analysis instead of at the closure review. Your response further stated that (1025) of the (1179) complaints were entered in January and February 2009, where (b)(4)% of the devices have either not been returned for analysis or analysis was in process. Your response did not explain the status of your complaint review during the period of June 2008 through January 2009. Your response promised to revise the complaint handling procedures by May 1, 2009 and provide additional resources by July 1, 2009.
The Agency is concerned that your company's untimely data entry could unduly delay investigating and confirming product problems, and identifying product failure trends. Data in your System Performance Reports documented that many devices were not returned from their users without providing any explanation. Without the returned devices, your company closed many complaints, and therefore, may not be able to conclusively verify if the recent design changes described in the above-referenced CAPAs have in fact corrected the past quality issues and will not introduce new problems. The investigators discussed this issue with your company during the inspection.
Responding to This Warning Letter
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, pre-market approval applications for Class III devices to which the Quality System regulation (21 CFR Part 820) deviations are reasonably related will not be approved until the violations have been corrected. Also, requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason
for the delay and the time within which the corrections will be completed.
Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your
products into compliance.


Sincerely,
Reynaldo R. Rodriguez, Jr.
Dallas District Director


RRRtxt
cc: Mr. Christopher G. Chavez, President
Advanced Neuromodulation Systems, Inc. (ANS)
6901 Preston Road
Plano, Texas 75024

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Additional information regarding “Adverse Medical Events” regarding St. Jude Spinal Cord Stimulators may be found on the FDA Website.

Similarly, the supporting documents accompanying the FDA application originally submitted by St. Jude may also be viewed. Reviewing the original research referenced in that section of the application reveals that there was no evidence to support the safety and effectiveness of the device for patients with CRPS.

This is the kind of company you will be dealing with.

St Jude SCS recall Dec 2011
 

The following recall warns of possible "explant" surgeries of St Jude SCS

December 19, 2011
IMPORTANT MEDICAL DEVICE RECALL
Re: Eon MiniTM Product Code 65-3788 (Spinal Cord Stimulator) Manufactured Before September 30, 2010
Dear Physician,
This letter provides important information pertaining to the Eon Mini implantable pulse generators (IPGs) manufactured before September 2010. As part of St. Jude Medical’s routine tracking and product monitoring, we have received 112 reports of Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. After thorough analysis, we have determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depleting battery voltage. Our post-marketing surveillance received 112 reports of premature battery depletion out of the 25,255 devices covered by this voluntary recall.
Our records indicate that you have implanted potentially affected device(s) or have a potentially affected device(s) in your product inventory. Patients who experience this failure mode may require a premature explant surgery. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned reoperations, and may include pain, scarring, and infection, as well as complications from anesthesia. We are therefore writing to inform you of the issue and to pass on additional advice from our outside Medical Advisory Board on patient management.
Issue Summary:
In the 112 complaints reported to date, product investigation and analysis identified a processing condition related to the positioning of components. Patients may have experienced a sudden loss of power or the duration between recharges became progressively shorter until the IPG failed to charge resulting in device replacement. The investigative analysis indicates that when the negative battery strap of the internal IPG battery comes into contact with the micro-processor board, a short to the IPG battery can occur, leading to this failure mode. We have taken corrective action and, as part of our normal post-marketing surveillance process, will continue to review complaint data to monitor the effectiveness of the corrective action.
In September 2010, we improved our manufacturing instructions to clarify the spacing of the internal battery component, to ensure proper component positioning, and to enhance inspection instructions. To ensure the effectiveness of the improved manufacturing and inspection instructions, and that process variations are not affecting our currently manufactured product, we have retrained all manufacturing operators and inspectors on the procedures for battery strap assembly and verification. Additional manufacturing process controls are also being considered.
Page 1 of 2 ATRIAL FIBRILLATION CARDIAC RHYTHM MANAGEMENT CARDIAC SURGERY CARDIOLOGY NEUROMODULATION
St. Jude Medical Neuromodulation Division 6901 Preston Road Plano, TX 75024 USA Tel 972 309 8000 Fax 972 309 8150
Rate of occurrence:
The current IPG failures attributed to this defect represent 0.44% of the total Eon Mini IPGs affected by this voluntary recall. The long-term failure rates for these devices are not known at this time. Devices with serial numbers listed in Attachment A were manufactured prior to the implementation of the improvements in manufacturing. Devices manufactured after September 2010 are not impacted by this voluntary recall.
Recommendations:
St. Jude Medical understands that each patient is different and recommends you discuss this issue with your patient as necessary. To further assist in your patient care, we are providing you with a list of all serial numbers we show have been distributed to you (see Attachment A). Following discussions with our outside Medical Advisory Board, St. Jude Medical recommends:
• For product that does not match the serial number listing, no actions are necessary. • For unimplanted inventory that matches the serial number listing in Attachment A, please contact your SJM Representative to have the device returned to St. Jude Medical. A
replacement device will be provided at no additional cost to you. • For implanted product that matches the serial number listing, as advised by our Medical
Advisory Board:
o It is recommended that you do not unnecessarily explant the devices associated with this advisory if the IPGs are functioning as intended.
o If there is a sudden loss of power or if the duration between recharges becomes significantly shorter, contact your St. Jude Medical Representative to evaluate if
 the recharge interval is within normal operating expectations based on the patient’s programmed parameters,
 the device is approaching normal end of life expectancy, or
 a device replacement is warranted. o If device replacement is required due to IPG failure related to this voluntary recall
notice, St. Jude Medical will provide a replacement IPG at no charge.
Transfer of this Information:
By informing you of this situation, St. Jude Medical is conducting a voluntary medical device recall. This voluntary recall is being conducted to the physician level. In the event that one or more patients or products potentially affected by this voluntary recall have been transferred to other institutions, please forward a copy of this documentation to the respective physician or institution. Please maintain a record of this notice along with the recommendations to ensure effectiveness of this communication. The Food and Drug Administration has been notified of this action.
Please accept our apologies for any inconvenience this may have caused you or your patients. St. Jude Medical is committed to keeping customers informed about important product information. If you have questions regarding this action, please contact your St. Jude Medical Neuromodulation Division Representative.
We will continue to monitor our manufacturing process controls and product performance for opportunities to improve our products, services and instructions for use. We thank you for your continued support.
Sincerely,
Steven Robertson Vice President, Quality Assurance St. Jude Medical, Neuromodulation Division
Page 2 of 2

I particularly like the apology of any "inconvenience" their "workmanship" deficient devices may have caused the patient.

There are success stories.....
 

With all due respect, there are quite a few success stories on these units. There are plenty of RSD patients (including me) over on the SCS forum who have had great success and have achieved a much better quality of life because of the SCS.
I respect the fact that yes, there are failed surgeries and even spread of RSD.
However, I feel that when someone comes along asking about these they should get a fair shake and hear both sides - negative and positive.

There are a few others on that list, Ballerina, who would probably take issue. Some post regularly regarding their implants and are happy with them. Some of the names you've mentioned have had to have some adjustments made perhaps, but I feel you are jumping the gun by assuming they are failed cases.

Just my 2 cents.....feel free to tell me where i can stick my 2 cents :o

Rae
:grouphug:

Everyone's 2 cents is valuable, particularly when it come to making a decision such as a spinal cord stimulator when suffering from CRPS. As regards my list I merely listed what folks reported, failures, revisions, and or spreads.

Thanks very much for your input. We are all on the same path and the more we can do to advocate for each other the better!

I appreciate everyone's input and the recall information found by Ballerina. As like everyone, I want relieve from my RSD without being in a coma everyday caused by all these medications. I realize my life will "probably" never be so called normal again, but the hope that I can get off some of the meds and possibly go back to work. Well I think everyone knows and agrees.

Hi,

I might add some comments to this discussion. Over a year ago while researching treatments for my daughter I came across this survey done
on a support site for RSD. Many questions were asked of RSD suffers,
concerning treatments, what did and did not work for them. Amoung the
questions asked was if any one tried the SCS and did it work for them.
Just today I tried to find that same survey and I will keep working to find
the results and post links if I am able to post links.

If memroy serves me many of the survey respondents said the unit helped for
about a year. However I am also assuming since those SCS were implanted
years before the survey was made that some of those units used were not
as advanced as some are today. I don't know.

I just noted on this same site an article by H. Hooshman, MD and Eric M. Phillips, neurogical assoiciates pain management Center. They say this.
"The following is a summary of our experience with treating complex regional
pain syndrome ( CRPS) patients who have undergone spinial cord stimulator
treatment for one year or longer." The success or failure of the treatment
with SCS depends on how early in the course of the illiness the SCS treatment started, and depends on the nature of the orginial nociceptive pain."

The article continues and can be accessed through RSDHope if I am permitted to provide that link.

As they say everyone is different so what may help one may not help another. Nevertheless traditional treatment usually lists a series of treatment each being more invasive than before so extreme caution must
be excercised

Food for thought

Joydee

Hi Joydee,

The article you referenced by Hooshmand does not recommend SCS for the treatment of CRPS.

Regarding the benefits of SCS for CRPS

“Usually the beneficial effect of SCS in management of CRPS is brief (a few weeks to a few months in more than 70% of patients)."


Regarding Complications

“The SCS can lead to a spread of pain from the original site to other parts of the body. The sesitization of the spinal cord by the SCS causes spinal cord sensitization in the form of myoclonic akinetic seizures.”

The most disturbing complication of SCS follows

“SCS can also cause disturbance of plasticity and causes rapid acceleration and deteriorations of CRPS to later stages of the disease. Another complication of SCS treatment is the fact that it stimulates the sensory neuropathic pain fibers in the spinal canal facilitating the spread of the disease."

Regarding SCS failing to halt the progression of CRPS

“Clinically, SCS may relieve the pain with the first few weeks or months of implantation. With the passage of time, the pain and associated vasomotor response recur."

An additional two cents from me...
 

I agree with Rae. In addition to myself, I am sure there are others who do not appreciate being on your list. A revision could be necessary for any reason, not just for equipment failure. My revision was not due to equipment failure, leads migrate - that can be because of human anatomy. RSD spread could be caused from a number of reasons. I have had spread, from injuries and a shoulder surgery.

Everyone comes here for input and support and appreciates what all have to offer. I think that when you post information, it should be current and not outdated. The FDA letter is old, companies make improvements and upgrades when there are problems. St Jude has. My rep told me about the battery problem and that it was fixed. You shouldn't scare people with old info. You also shouldn't tell people that they should find a new doctor if their doctor doesn't recommend the same treatment that you feel is the correct one as you have in other posts.

I finally have a great doctor who I am very comfortable with, he recommended two SCS to be implanted as the last resort for me after many other failed treatments. Never recommended tDCS. I did my research on everything and I am fine with my choice and my doctor. I am able to continue working as I regained use of my hands...this is far from failure.

Nanc

Sorry you had an unsuccessful experience. I sure hope you can get better relief this next go around. Please keep us posted. Since I have RSD in so many different areas in my body, they did the trial on my upper left side, at first I wasn't too happy about it but then it was good because i was really able to compare my two sides against each other. It was a great comparison as the pain was greatly reduced in my left arm/hand and I still had it full force in my right hand. I could tell the difference on how it would feel!

My doctor works with different manufacturers, but St Jude was his preferred company. He said they were the best ones. I understand why, the reps I have are great.

I really hope you are feeling better soon.
Nanc
:hug:

Can you please provide the reference or link to this information?
Also, have you come across any positive info in all of your researching, beside the 'benefit' you mentioned regarding temporary relief?
Thanks

Alt
 

I really get the whole of the inquiry into all questions about any device to be placed in a human body. Prior to surgery I researched forwards, backwards, sidewards, and on the Z axis looking for anything written about the St. Judes system. I built an entire file regarding my research. Patients who had received the product were willing to be interviewed by me..... and I did. All of this led up to my trial.... where I found out the rep in attendance was not from St. Judes at all. The guy was from Boston Sci.

Now I know Boston Sci has had its issues as well. I have read the articles. Researched the litigation. Been there and done that now on both St. Judes and Boston Sci. Even so, I did accept an implant.

Yep, Ballerina here has visited my profile. I did not see my name on her list, so I reckon she must have read what I wrote. One of the blessings I count in my life is this miracle of the result of the implant having enabled my full withdrawal from all pain management meds, my return to my profession, the earning of revenue, much needed revenue for my family which has now led to our ability once again to own our own home. Why am I distince from others whose system seems to be problematc? Why do I count the SCS as a blessing as Tchr012 now does (sorry Ballerina, but while Tchr012 did have troubles earlier, her later writings include the significant gratitude she now expresses after revision- the news is not the news fully reported unless it is fairly represented)? I am certain success is influenced by patient involvement in the actual program session of their device. Not as a slab on a table responding to a game of 20 questions played out by a rep. I FOUND SUCCESS I BELIEVE, now corroborated by others, by reason of being allowed to "sit at the computer and drive the keyboard as I programmed my device" under the watchful eye of my rep.

I am fully withdrawn from pain meds for well over a year. I am fully controlling pain with the implant. I have not ever had a tweak session as I have not needed any such session, and my rep knows me as someone who calls in to thank him for helping me regain life.

From now until doomsday, I will write, speak, cajole, push, prod, and stump for PATIENT INVOLVEMENT IN THE PROGRAMMMING OF THEIR OWN DEVICE. No rep, physician, or inventor of whom I know has a means of empirically obtaining knowledge how their tweaks affect the human body. Those who attempt programming thusly may as well be truthfully telling their patient "this is my best WAG.... Wild * Guess." We who have experienced programming our devices, though our numbers may be small for now, seem to experience specific beneficial results.

For this reason I am on a campaign to prompt other reps to allow patient hands on programming. Maybe, just maybe it would improve the effect for all users..... including RSD and CRPS. I have written on this forum about my sister in law Terri, who suffers RSD. She asked me to write that post. Her words about the stim I enjoy.... "Oh, how badly I wanted to try that too, Mark! But my doc said I was too far gone and it would not help me." She agreed. She is a double amputee due to RSD. She bears a chipper effort to help others despite functioning on so much Morphine she nearly has no benefit from it any longer either. Pain is her constant companion, an unwelcome companion.

Here is hope for everyone indeed.
Prayers too,
Mark56:grouphug:

I am grateful for all the responses and am looking forward to my trial. Even though I have had rsd for only 3years (almost 3). I have to risk the possiblity of spread, failure, etc. The nervous feeling I had is diminishing some because I know that this could work for me as well.
Marc, I am sorry to hear of your sisterinlaw, I will definitely pray for God to give her some relief. But I was glad to hear you have returned to work and off all your pain medications. This is what I hope for myself and every person in pain. I still remember a day that did not consist of pills and patchs and I hold on to this. I know that everyone has opinions and I appreciate all sides to helping me stay informed. I have done some research on my own as well, but wanted other RSD'ers and SCS'ers opinions and comments of their experience.
My trial is scheduled for Feb. 21 so I will keep everyone informed on my progress.

Good Go Alt
 

Your approach and attitude is precisely what this entire forum bound by threads IS all about. Open inquiry into the unknown as you test the waters.

There is no medical procedure without risk, the foundational reason all providers uniformly require we who consume their services to sign off to paper after paper purporting to document our "informed consent" to the risks of a procedure. Rarely do such signatures hold up to the judicial inquiry into bad practice or mistaken misteps in the work done on the patient, but lawyers being what we are, we try to help people paper themselves with protection in hopes it will hold.

So, back to your quest for knowledge, information, a basis from which to decide. I, too, was VERY full of trepidation regarding still another surgery now that I have been through 29 to restore me and, you know, there was a nagging thought in the back of my mind the "law of averages" kicks in somewhere along the continuum and something could go wrong. Bottom line, I WAS afraid. Pure and simple.

I prayed, I studied, I knew life on meds in my bed was not a life which could alone restore income to my family and at one time we had a RICH income. A Huge motivator was I HURT constantly despite the meds, and it was the meds stupefying effect and sedation effect which rendered me asleep much of this time like my SIL Teri [I misspelled it earlier, she will forgive me]. She is driven to sleep quite a bit by her levels of meds, a coping mechanism and definitely not a vivacious life. I wanted more for me and for my family.

Thus prompted, I took the step of Trial surgery to learn still more whether the therapy of SCS could help me with pain management. You know from reading my posts, it did.

Still, I feel for myself and others who may be thus allowed the definite cinching of the bridle and saddle toward the road to success was on top of my excellent team...... I WAS ALLOWED TO DRIVE THE COMPUTER IN THE ALL IMPORTANT POST PERMANENT IMPLANT SURGERY PROGRAMMING SESSION. I know my pain. No one else does. They only attempt to learn via tireless completion of 1 to 10 scale forms some documented indication of my pain. That is the best medicine has to offer given current technology..... a piece of paper with a 1 to 10 scale completed by the patient.

FOR THIS REASON I asked and was permitted to drive the programming of the computer under the watchful eye of my rep. It was elementarily simple, plus every tweak I MADE to the computer produced immediate results I discerned, and through trial and error of my own I did dial myself in. No tweaks thereafter at all. No crying to the doctor for pain management meds because it does not work for me, and you know the rest. I feel utterly blessed.

Now, lest I lead anyone who reads down a path of pitfalls for the unwary, everyone has to know:
1. SCS is NOT for everyone, thus the careful steps leading up to its utilization on any patient. There are patients just ill suited to the stim.
2. Stim does NOT solve all problems. It is a therapy for pain MANAGEMENT and NOT some panacea cure all; in fact, it cures nothing. Its utilization is intended by the manufacturers and users to confound the brain into wrapt submission not to FEEL/interpret pain signals as pain. For this reason, I have written, the body will still experience pain though the brain which interprets it will be confounded.

The result for me is best understood walking in my shoes- Though I have resumed a good portion of my pre-car wreck and trauma life, this body which contains me is still bedeviled by the pain stimulus. No, my brain does not usually recognize it; however, my body builds up to a point of rest requiring fatigue by day's end greater than I experienced pre-injury. I TIRE.

In this recognition, I have come to know I cannot work as once I did routinely. Monday of this past week, I worked from 9:30am to 12:30am the following morning to deal with issues bedevilling me at the office. I tended to practice in this way before injury just because the "law is a jealous mistress" so they teach in law school. I was overwhelmed with fatigue thereafter, because I had put the body through too much, and by Wednesday, it showed in my bearing and my face to my co-workers. I had overdone. I went home early that day and to bed to catch up on rest. Then I implemented a resolve with my understanding corp President to force me away from the office at a more reasonable end of day time.

While stim has enabled my return to work, I STILL HAVE LIMITATIONS, new limitations to integrate into old well established work patterns. I was ultra-successful as a lawyer in my prior corporate life due, in part, to my strength and work ethic. GET THE JOB DONE. Now the work ethic has to be tempered by bodily limitations since pain is experienced by tbe body although usually I do not sense it.

3. Pain- There will still be pain spikes. Times when the pain breaks through and that GAWSH awful burning of hades impedes my gitalong. When a spike occurs, having no meds, I retire to bed and ramp up the stim to the point it overcomes the pain. Now, such levels of stim WILL produce sensations in the body which one may define as uncomfortable.... but the most creepy side effect thus utilized is paralysis rather than parasthesia. I have to be in bed, because the lower half of my body responds to the ramped up stim by stepping over an edge and I cannot will myself to even walk at those moments.

My Doc is concerned by such strong usage, but I am determined NOT to use pain management meds again. We have agreed together I will use the stim in spike contol mode with due care.... running it down to check on the pain spike to determine whether it has abated so I can safely return to normal usage. Thus far no lasting paralysis side effects have remained once I decrease the stim. No whilte papers exist on my usage in this manner, the reason for my doc's concern. We are making history. I am the guinea pig.

I have to confess even with all of this I feel blessed to be back at my profession.

4. I have deep and abiding faith, and it is this feature of my life which has been with me on this life experiment..... so when people wonder "how can you deal with all of this?" I answer "I am blessed, how about you? Have you not prayed for me? Don't you have faith in the prayers you have lifted on my behalf?"

5. Back to Teri, a double amputee high on the thighs of both lower extremities due to the insidious and gangrenous form RSD can deliver. She had no real choice in those events. Phantom pain still is with her. Since she is whole body RSD now in late stage, she exists on morphine as I indicated well over a year ago posting as she requested in this forum. Seeing what SCS "self programmed" did for me, she inquired into possibilities for herself because she would now do nearly anything to escape the pain.... but it is far too late in her case to have any likelihood of success and she is fragile. So, she revels in my success and preaches to others around her who know RSD there is a potential therapy which MAY help. But remember the distinction in my case over most others is the self programming feature I was allowed..... and I rejoice at having been so allowed.

Sorry this is such a long post, but much needed to be written for realism to be presented. SCS is not pie in the sky. It is serious stuff to be approached carefully by one who is not faint of heart.

I pray this may be of help to you ALT, and the many decisions which lay before you,
Here for you anytime,
Mark56:Heart:

Marc,

It's nice to know and have someone of such great faith as a friend. I understand nothing is without risk, but without taking risks in life we will never know our true potential. Whether a stimulator, a job, education, or marriage. Everything is a risk.
This may or may not work, but I feel I am ready to take this step in life. I also have decided that if this doesnt' work that I want my pm doc to refer me to someone who does ketamine. My pm only does stim's and blocks. He is not pro ketamine at all.
I feel bad for terri and will continue to pray for her relief. Was her only problem RSD?
As far as work, I am not working at all right now and am a nurse by trade. I have re-enrolled in school to get my bsn and hopefully my msn. I would like to go into teaching and legal nursing. (my husband always says I should have been a lawyer) But I know I will never be able to lift another patient.
I also know that I will have limitations and I feel that this will give me the oppurtunity to work from home and still recieve an income.

I am sorry you are unhappy with being so listed. Once again, I merely listed what folks reported regarding Spinal Cord Stimulators being used to treat Complex Regional Pain Syndrome resulting in failure, revision and or spread of the CRPS. The reader of the posts may decide for themselves the level of risk they are willing to take. My list is only a partial list since I only spent a few minutes searching.

Regarding my posts about the equipment failures, many folks would like to be as thorough in researching medical devices put into their bodies as they would the safety rates of cars they are buying.

It is not surprising that your physician did not suggest tDCS prior to SCS implantation. Hopefully it was not due to financial consideration but rather ignorance of the procedure. There is now training in the administration of tDCS available to physicians.

The Institute for Noninvasive Brain Stimulation of New York, Beth Israel Hospital www.newpaintreatment.org/
I was impressed when I recently checked the website. Now they are actively seeking patients for tDCS treatment of pain. When I sought treatment there this time last year I had to work to get in. Now they are offering training in tDCS to physicians, which includes its application for CRPS.

2) There is a brand new Brain Stimulation Clinic in Atlanta, that just opened this month. www.transcranialbrainstimulation.com/
This is offered through a private pain treatment clinic operated by Dr. James Fugedy, who, interestingly enough at one time recommended SCS for CRPS but stopped doing them because of the high failure rates. He might be a good resource for any physician seeking to learn about tDCS.

3) The Brenson-Allen Center for Noninvasive Brain Stimulation, Harvard Medical School. http://tmslab.org/
This facility offers specific physician training in the application of tDCS to Complex Regional Pain Syndrome and related form of neuropathic pain.

Do I think CRPS patients should be informed of and offered all non-invasive and effective treatments prior to SCS implantation? You bet! Do I think if all options are not exhausted first CRPS patients should seek the opinion of another doctor? You bet!

It is not that I don't feel SCS is a "correct" treatment for CRPS. When I called the manufacturers and ask for research demonstrating the safety and long term effectiveness of their product in the management of CRPS, they could not provide that to me.

Re Teri
 

Hi ALT-

You are truly beginning to sound as did I when I approached SCS Trial. I had doubts a many, hesitation in the volume of a boat load, and the full realization I did not want to finish my days [for they may be many as I am in my 50s] a prisoner of my bed........ medicated. Thus, I leapt in faith after a lot of prayer, and how happy I am this was the path for me.... not for everyone, of course, but for me.

I pray your situation will demonstrate improvement according to your decisions. Pain is a long hard road, and if you can get away from it, I would be thrilled for you.

Teri, well, she was both a very active oil artist and chef for a restaurant. Long years on the feet had done a number on one, just one of her knees. She had a "simple" knee surgery to correct some damage, and was happy for its result; however, this very surgery precipitated her RSD which spread whole body. She no longer even had knees, and she jokes about having gone from 5'8" to around four feet in height. A healthy sense of humor and an abiding faith she has, each in good measure to cope with her situation.

She gets around via motorized wheel chair, a husband who is so very conscientious for her sake, and a medicaid supplied nurse who spends time each day with her, seeing to her needs. She paints t-shirts with messages of hope for cancer patients in a local hospital and personally delivers the same to the patients. She, like my wife and I, has taken lemons and made lemon pie. She, too, counts blessings, and looks forward to the moment she meets God.

Life is full of challenge, which becomes opportunity, which transmutates into fields of flowers known as blessings,
May you be so blessed my friend,
Mark56:hug:

Hi Ballerina!
 

You are tireless in your efforts, and they are many, to bring messages of researched information to others in need, for this IS the place seekers come to find reality in appraisal of methods of approach to their varied situations. You bless others with your efforts to inform, and may you in those efforts feel the rebound of blessings which enrich your soul filled being to overflowing. It is well and truly a full heart which comes from good intentioned delivery of information to assist patients the world over in making more fully informed decisions about their care.

May you never tire from your ministry, and may you be constantly refreshed in the knowledge you are endeavoring to provide help in a world full of needy people as I once was,
Gratefully,
Mark56:hug:

Here is the reference you requested. It is probably not new info for the folks on the SCS forum who are avid researchers. If this is the first time on Hooshmand's website please spend so time wandering around it. Lots of helpful tidbits for managing what we all struggle with.http://rsdrx.com/crps_and_scs.htm

Hope this helps.

[QUOTE=ballerina;840627]Hi Alt,

Please do your own extensive research regarding Spinal Cord Stimulators of any kind and CRPS.

Please see below for a start.

http://neurotalk.psychcentral.com/sh...timulator+CRPS



Add CRPSjames to the list of people with CRPS with failed Spinal Cord Stimulators

How did your trial go with the Spinal Cord Stimulator?

Workers comp. did not approve. It has to go before their board or something. I tell you because of my last set of LSB's and the mild winter. I had an oppurtunity to really push my foot and am now off the roll a bout and doing so very better that I am thinking about declining the stimulator for now unless things go down hill again. I appreciate you asking. I'll keep you posted.

So glad you are doing so much better. It is great that you are off the roll about. It may well be a blessing in disguise that WC denied the spinal cord stimulator. I know that several insurance companies are no refusing spinal cord stimulators for CRPS patients due to the high failure and complication rates.

Hope you continue to make great progress. If things take a step in the wrong direction please consider tDCS-non-invasive, cheap and if you are a responder it can be very effective.

Thanks. I have been following the thread somewhat on the TDCS and am up for trying. Will keep you posted.

I Feel For You
 

Nanc Sorry To Hear About You Having as many St Jude Stimulators As I Do But I So Upset With Them I Need To Have Mine Removed But I Wonder If Medtronics Could Help Me Take Over My Current System Or Id The Paddles Would Have To Be Removed And Replace Because They Are Finally Scared Into Place Now And I Need To Do Something About It I Have St JUde Reps In Nashville Tn But They Decided They Want Come To My Area Anymore And Make Any Adjustments So The On One I Had Put In In Late December My Cervical One Has Only Been Programmed With 2 Programs Put In It When I was Leaving My Dr Visit After The One Week Check Up So I Use To Love The Company Now I Hate Them For The Way They Cam Just Change There Ruals And Im Not Driving 6-8 Hours A Day Everytime I Need To Get Some New Programs Or Some Adjusted And Gas Is High It Hurts Me To Drive And Im A Disabeled Veteran And You Think They Could Help But There Is A Local Dr I Know That Does The Medtronics And I May Need To Call Him And See If He has Any Sugestions For Me, This Has Absoultely Made Me Sick At My Stomach

No After 2 of them in me im lookin foward to having them removed especially from unprofessional reps that make up rules as they go so all i can say is no there not worth it as a Disabeled Veteran and sorry support over rules any pain relief

Hi Tony, so sorry to hear about the difficulties you are having with SJM. It seems like there would be reps closer to you and more willing to help. Have you contacted the company (not the reps) about the refusal of treatment? I guess I am lucky, I have three great reps that cover my area and can program me, if needed, usually within a week. They set me up with many programs on both the cervical and thoracic stimulators...gave me a lot to work with.
I sure hope you can find some relief soon!
Nanc

Luck is not exactly the word I would use
 

I had an implant in 2008 to treat migraines and it worked for about fifty percent of my specific targeted pain. This year I had the original removed and a new one (the Mini) implanted with paddles in my epidural space to treat neck and limb pain (right arm and shoulder). Last week I had a second surgery to connect new wires to treat the original migraine pain. Now the little battery doesn't seem to be holding a charge and isn't supplying enough power to treat the targeted areas. Please understand I am still recovering from the surgery and the company rep. is going to do her best to change the configuration. If new programs don't work I have to either have a second mini implanted or a larger battery. Wish I would have done my research on the recent problems the company and device is having. My 2008 implant was a life changing event, this year I feel I went backwards...:(

Eon - ANS
 

My mother had this device implanted in Brazil, she is visiting in the US and went through a Metal Detector at Marshalls and the device lost its program.
Where could she find someone in MAryland, to reprogram the device. She is in Excruating pain. She has 16 pins on her back, and it is all crooked inside of her, and she needs the device to work properly in order for her to move or walk.

I appreciate any information. Thank you all in advance and Best of luck.

**

Your mother should have a medical device implant card for emergency situations that has the contact # on the back. If you call the number then they will be able to direct you to the nearest physician for emergency service. If not I'm sure there is a patient care line via the manufacturer's website.

So sorry your mother is going through this.

Yest, I have one that has been in for 16 months and it's great

Welcome djones144. :Wave-Hello: