FDA Adverse Event Death Summary report: N

PROFILE MD V-186 SERIES TIERED THERAPY DEFIB.

MDR report key: 407529 · Received July 24, 2002

Report

Report Number
2938836-2002-00314
Event Type
Death
Date Received
July 24, 2002
Date of Event
May 28, 2002
Report Date
May 28, 2002
Manufacturer
ST. JUDE MEDICAL, INC., CRMD
Product Code
LWS
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED TO ST. JUDE MEDICAL THAT THE ICD WAS EXPLANTED WHEN EARLY BATTERY DEPLETION AND EXTENDED CHARGE TIMES WERE OBSERVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PROFILE MD V-186 SERIES TIERED THERAPY DEFIB. IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-186HV3 NA

Patients

Seq Age Sex Outcome Treatment
1 71 YR Other THERAPY DATES: NA.