When problems develop with a medical device, the hospital submits a report to the Food and Drug Administration's "Manufacturer and User Facility Device Experience" (M.A.U.D.E.) database. I am unsure how they derive the acronym. But fourteen reports regarding Synapse Biomedical's NeuRx DPS were filed since 2009 (not all involve ALS patients). Twelve of these reports reflect issues resolved with the patient continuing to use the device. Some were ALS patients, some SCI patients. There were two deaths, one from an ALS patient who suffered a pulmonary embolism the day following implantation (the remainder recovered and usually continued to use the device). Most of the reports involved conflict with cardiac pacemakers; initially cardiac pacer patients were ineligible for the pacer but the FDA expanded eligibility and surgeons have successfully co-implanted the devices. The first M.A.U.D.E. report was in Dec, 2009 before the device was approved. The most recent was Feb, 2016. The reports often do not identify the hospital in question. The Feb report involves a second death but the code DTB is used rather than the code for the pacer (OIR). A source believed to be a VIP with ALS Worldwide recently reported over 1,600 ALS patients have been implanted with the pacer. The Feb report contains almost no information for appraising the case and I have no other information about the case or any of the other cases filed.

I meant to add the URL:

Manufacturer and User Facility Device Experience
https://www.accessdata.fda.gov/scrip...ude/search.cfm

You will need to enter "Synapse Biomedical" in the Manufacturer field and change the dates . . . use 2000 for the year to start and add one month to the date in the end period; then 'click' "search" button. I haven't figured out how to cause those steps to occur automatically.

I believe the first one remains under evaluation (February 2016).

There are two further reports about the case of parent observing their PATIENT using a video monitoring device. They found the patient was not breathing and they were not able to revive them. The new reports indicate the NeuRx device was found to be operational by an independent testing lab and the patient was not an ALS patient. The reports lead me to believe further news will develop.

I thought I should add, a pulsox meter would likely have prevented this tragedy. Pulsox meters are designed with the idea in mind they may be protecting someone from an immediate death. Video cameras might also be helpful but they are used in so many other contexts they are unlikely to signal even if such need were 'obvious.' Please use pulsox meters . . . there probably are some computers can read the data from . . . we always need more data.

no new cases found, this years cases appear not to involve ALS patients.