FDA Adverse Event Death Summary report: N

BOSTON SCIENTIFIC

MDR report key: 1972706 · Received January 22, 2011

Report

Report Number
MW5019140
Event Type
Death
Date Received
January 22, 2011
Date of Event
January 8, 2011
Report Date
January 22, 2011
Manufacturer
MEDTRONIC
Product Code
GZB
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
DC, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

PT WAS FOUND UNCONSCIOUS IN THE BATHROOM OF HIS WINTER CONDO IN (B)(6), ON (B)(6) 2011 AND WAS TAKEN BY NEIGHBORS TO A LOCAL HOSPITAL - (B)(6). I, HIS BROTHER, WAS SUMMONED AND TRAVELED TO (B)(6), ARRIVING LATE EVENING ON (B)(6) 2011. IN MEETINGS WITH HIS DOCTORS ON (B)(6) 2011, THE CARDIOLOGIST SAID THAT A READING OF HIS PACEMAKER INDICATED THERE HAD BEEN TWO RECENT SURGES FROM THE PACEMAKER, ONE ON (B)(6) 2011, AND ANOTHER ON OR ABOUT (B)(6) 2011. IN THE (B)(6) INCIDENT, IT WAS REPORTED BY HIS NEIGHBORS THAT ON THAT DAY IN THE (B)(6) SUPERMARKET CITY CLUB, HE COLLAPSED ON THE CONCRETE FLOOR, STRIKING HIS HEAD. HE WAS TAKEN TO THE SAME HOSPITAL WHERE HE WAS PRESCRIBED A BLOOD THINNER. THERE WERE NO WITNESSES TO THE (B)(6) INCIDENT, WHICH TOOK PLACE IN THE BATHROOM OF HIS RESIDENCE IN (B)(6). THE CARDIOLOGIST SUSPECTED A SURGE CAUSED HIM TO COLLAPSE IN HIS BATHROOM AND STRIKE HIS HEAD ON A HARD SURFACE. HE LAID THERE UNCONSCIOUS FOR SEVERAL DAYS UNTIL CONCERNED NEIGHBORS FORCED THEIR WAY INTO HIS APARTMENT AND DISCOVERED HIM. THE CARDIOLOGIST BELIEVES THE PACEMAKER KEPT HIM BREATHING THOSE DAYS. PT WAS ADMITTED TO THE HOSPITAL WITH HYPOTHERMIA, ARRHYTHMIA AND A "VASCULAR PROBLEM" IN HIS HEAD. AFTER CONSULTING NEUROSURGEON (B)(6) AT (B)(6) MED CTR IN (B)(6), I AUTHORIZED SURGERY TO RELIEVE BRAIN SWELLING AND CLEAN A CLOT IN THE HEAD AFTER CAT SCAN REVEALED THAT PROBLEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BOSTON SCIENTIFIC MEDTRONIC AICD GZB MEDTRONIC D154AWG
2 BOSTON SCIENTIFIC LEAD GZB MEDTRONIC 0185

Patients

Seq Age Sex Outcome Treatment
1 66 YR Death| H| O