Recalled Pain Pump problems
 

I am new to this site and have an extremely frustrating situation. I was in a boating accident in 2004 that severely damaged the entire upper left side of my torso. After spending 2 weeks in intensive care out of state until I was able to travel back home and 5 weeks out of work, my primary doctor immediately referred me to a pain specialist. The permanant damages I was left with could not be cured by surgery. After exhausting any and all options over the course of years to remedy my pain issues (there are 3 different diagnosis for the permanant damages), I tried the stimulator, and the pain pump was the only other option for me to get the best pain relief. This is my dilemma.

In Oct 2011 I finally had the pain pump implanted. If any of you have the pump, you know the pump requires ongoing forever maintenance from your pain doctor. In January 2012 I discovered the pump had been FDA Class I recalled in June 2011. When I called my the doctor to address this with him, he would no longer take my calls. His "office" denied any knowledge of the recall, but I couldn't get the doctor to take my call or call me back. I was forced to get my primary doctor and the insurance involved and I had to move to another doctor. The experience I had with doctor 2 was devastating to say the least. I became quickly apparent he didn't want me as a patient. I felt desperate. I won't go into details, but after 2 1/2 months with dealing with him, I again had to work with my primary, who again had to refer me to another pain doctor, which is now outside our group. Dr. 3 sits on the California Board and immediately questions why I'm at doctor 3 and I had to explain to him my treatment from Dr. 1 and Dr. 2. He told me that he understood what was going on... Dr. 1 and Dr. 2 were pervious partners. He also said that I have a "ticking timebomb" in my body and must immediately get my pump replaced.

I can't get an attorney to take this on because the pump hasn't injured me "yet"... I feel so desperate.....Has anybody dealt with a situation like this before???

I assume this is a Medtronic pump. The way the FDA wrote up the recall, stated that all devices on the shelf were to be recalled and not inplanted in future patients. The recall did not cover patients that currently had them. They are to be removed and replaced as needed. In other words, the way things stand Medtonic does not have to step up to the plate until you go into crisis. Many ins. companies will not get involved or pay for replacement surgery to prevent a problem that has not and may not happen. Hopefully, that will not happen. Prayers and best wishes.

Recalled AFTER the recall
 

Hi Spine95: Yes this is the Medtronics pump. It was implanted AFTER the recall. The recall was in June of 2011 and mine was implanted in Oct 2011. When I found this out in Jan 2012 I found my serial number and went onto Medtronics website where you can key in your serial number and mine was on the recall list. So I called Medtronics. They told me they were not going to take them off the market because they felt the failures were such a "low risk of failure"............ They were "mandated" to take them off the market....

Frustrating bryond frustration
 

They should be :deadhorsebeat::deadhorsebeat::deadhorsebeat::dead horsebeat: and then :deadhorsebeat:. I understand the attorney letting you know there is no "harm" yet but........ goodness sakes alive!!!!!!!

Mark56

Welcome, Besidemyself!
 

Hi there, and welcome to NT! This is a great place to get information, vent your frustrations, find support (and give it), and even find friends. I'm so sorry that you're getting the runaround regarding your recalled pain pump! How frustrating that must be, and how scary. Hope your current doctor will jump on this and get it fixed for you. Meanwhile, hang in there and let us know if there's anything else we can do to help! I'll keep you in my prayers.

Welcome hugs,
Jan ;)

Update
 

I had an opportunity to meet with Medtronics yesterday and they are telling me the pain pump was "never recalled"........ I met with the local sales rep in the doctor who installed it's office. I said, "You're kidding me right"..... I don't think he realized how much research I had done on this issue and with the FDA... I showed him the FDA Recall and showed him Medtronic's letter "to the public". Then he showed me... supposedly, what HIS instructions were.. (from his computer)... and that was... "Continue issuing the pumps until we exhaust the inventory and the new ones come out"... He stated that HE personally wasn't aware of a Recall............ Is there a coverup or something. I guess the sales rep was sent in there to make me think there really isn't a concern here. But I left the meeting telling him that HE is not the person I needed to speak with. I told him that Dr. 3 said I had a "ticking timebomb in my body" and the FDA Class I Recalled the product and I don't know what he had on his computer and don't CARE. He asked me what I wanted and I said I want the pump REPLACED with a GOOD PUMP. I've told him about some of the horror stories I've been reading on these message rooms because of these bad battery issues and I don't want to be a statistic. What Medtronic did by continuing to issue the bad pumps after they were recalled is Against the Law and downright criminal and I'm not going to let them get away with it.....

Go get 'em!!!!
 

I trust you have been documenting all conversations (names dates times places) with every person involved in this fiasco. If not, reconstruct as best as possible and start detailed documentation immediately. I try to limit my communication with the enemy ;) via email for obvious reasons. They prefer the phone or face to face for obvious reasons. I tape record all meetings. That tends to reduce the bull $hit level a bit.

Your surgeon is not completely innocent in this matter. If he was not aware of a recall on devices he installs, he is not doing his homework. I am betting he was aware but failed to double check the model number on the device before installing it. Either way, that's a big no no.

Did ins. cover this or any part? If so, they need to know that they were sold a recalled device. I understand their position that replacing it is not their problem if you are not in crisis. I don't like it but I understand it.

It sure seems to me that since you had one inplanted AFTER the recall date, you are justified in demanding a replacement at no personal expense. Are we talking about SynchromedII model 8637-20 or 863740?

I too have a "recalled" pain pump,..JUST found out about this LAST night, surfing the web! My pump was implanted in July of 2011...the recall was in Jan of 2011!!! Same serial number!! So yea, I AM FURIOUS?? And now I am sitting here, the reason i was "surfing" in the first place, is because my pain pump site, is the size of a softball!! Its HUGE and it has never swelled up like this!! Of course, Hubby gets 2 days off in a row, and this? I fig, if pump was broke and releasing all my dilaudid, i woudln't be here typing right now..but has ANYONE else had problems with their pain pump swelling like this, a YEAR after surgery? And I believe, i hear "class action law suit" in the near future if enough of us get together and PROVE they implanted these in us AFTER THE RECALL DATE!

Oh Good Grief!!!
 

Practitioners implanting recalled devices knowingly? Worse than products liability........ this goes to the heart of the practice...... Yep, I can smell this wone beginning to deveop. May all of you who have these issues be served by someone who will PUSH THE ISSUE with those who placed the items within you.

Prayin for ya all.
Mark56:grouphug:

Keep searching don't stop
 

dear friends

it is so sad to hear
the irresponsibility
the doctors are displaying
as if there is something
fishy under the noses of these
so called experts
it doesn't take an expert
to figure out
a direct order
operative word ORDER
TAKE THEM OFF THE MARKET
ANY DOCTOR FOUND TO HAVE
AND THERE IS NO EXCUSE
THEY KNEW MAKE NO MISTAKE
i am so sorry to hear this
it make me so upset
AND THE AUDACITY
TO WHISTLE THE COST
OF INSURANCE
dear GOD help them
with the truth


someone who cares