US FDA MAUDE Adverse Event Reports
 

sample (Genuine) report:

MAUDE Adverse Event Report: SYNAPSE BIOMEDICAL INC. NEURX DIAPHRAGM PACING SYSTEM

there are presently twenty-two reports in the United States Food and Drug Administration's "Manufacturer and User Facility Device Experience" database pertaining to the Synapse Biomedical device. There is at least one new report since I last checked. I believe the recent reports do not involve Amyotrophic Lateral Sclerosis patients. In some cases there are multiple reports involving one incident. Many of the reports involved an infection resolved with antibiotics. Although I have not reviewed the entire set of reports recently, I recall two deaths - one involving an amyotrophic lateral sclerosis patient and the other was probably not an amyotrophic lateral sclerosis patient . . . the reports are not always clear on this issue. The device was not believed to have caused or significantly contributed to these deaths.

A number of remarks can be found on the web raising concerns regarding the device but the remarks are not sufficiently specific to provide opportunity to check out the story. Adverse events are supposed to have corresponding reports.

I am nearing completion of my review of DiPALS and RespiStimALS reports and hopefully will be able to report my conclusions soon. These studies may not have basis for refuting the pacer efficacy claims . . . the patient test subjects may have missed substantial benefits developing primarily during sleep . . .

May I suggest if you encounter individuals raising concerns regarding the pacer . . . ask them for particulars . . . was the issue reported?