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. |