FDA Adverse Event Death Summary report: N

FISHER WALLACE STIMULATOR

MDR report key: 2018257 · Received March 8, 2011

Report

Report Number
MW5019745
Event Type
Death
Date Received
March 8, 2011
Date of Event
November 25, 2010
Report Date
March 8, 2011
Manufacturer
UNK
Product Code
GZJ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

(B)(6), M.D., WAS MY SIGNIFICANT OTHER. ON (B)(6) EVENING, SHE EVIDENTLY PASSED OUT ON A FLIGHT OF STAIRS, FELL APPROXIMATELY A FULL FLIGHT, AND HIT HER HEAD ON THE FLOOR. SHE WAS IMMEDIATELY BROUGHT TO (B)(6) HOSPITAL AND PUT IN THE NEURO-ICU UNIT WHERE SHE DIED OF A BRAIN BLEED ON (B)(6) 2010. (B)(6) HAD BEEN, SHE TOLD ME, REGULARLY USING A FISHER WALLACE STIMULATOR. I TRIED IT ONCE, FOUND IT UNPLEASANT AND NEVER USED IT AGAIN, BUT A FEW WEEKS LATER PASSED OUT WHILE RIDING A BICYCLE, AND ENDED UP IN THE EMERGENCY ROOM OF (B)(6) MEDICAL CENTER IN (B)(6). AT THE TIME, I DID NOT ASSOCIATE MY FALL WITH THE FISHER WALLACE DEVICE, NOR DID I AT THE TIME WHEN (B)(6) FELL. HOWEVER, IT OCCURRED TO ME RECENTLY THAT (B)(6) HAD BEEN USING THE DEVICE REGULARLY DURING THE DAY, SHE TOLD ME, TO HELP HER SLEEP. HER AUTOPSY REPORT BY THE (B)(6) MEDICAL EXAMINER, AS EXPLAINED TO ME BY HER SON, IS MYSTERIOUS. IT SAID, SHE PASSED OUT DUE TO AN INTERNAL BRAIN HEMORRHAGE, THE CONSEQUENCE OF HYPERTENSION. THIS WAS CONFIRMED, ACCORDING TO HER SON, BY MICROSCOPIC EXAMINATION OF HER BRAIN AND HEART TISSUE. HOWEVER, (B)(6) HAD BEEN TO A CARDIOLOGIST WITHIN THE PREVIOUS SIX OR EIGHT MONTHS AND TO AN INTERNIST WITHIN THE PREVIOUS THREE MONTHS AND NEITHER HAD REPORTED A HYPERTENSION PROBLEM, NOR WAS SHE TAKING HYPERTENSION MEDICINE. THE FISHER-WALLACE DEVICE MAY NOT BE THE CAUSE, BUT I WISH SOMEBODY WOULD COLLECT DATA ON USERS AND BRAIN BLEEDS. I DO NOT KNOW HOW (B)(6) OBTAINED THE DEVICE. IT WAS LAST IN THE POSSESSION OF HER SON, WHO LIVES IN (B)(6). DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: INSOMNIA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FISHER WALLACE STIMULATOR NONE GZJ UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death| H