FDA Adverse Event
Death
Summary report: N
SENTINEL
MDR report key: 383834
·
Received March 15, 2002
Report
- Report Number
- 2184056-2002-00008
- Event Type
- Death
- Date Received
- March 15, 2002
- Date of Event
- February 11, 2001
- Report Date
- March 15, 2002
- Manufacturer
- ANGEION CORP
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DEVICE WAS EXPLANTED AFTER PT'S DEATH. EYE WITNESSES REPORTEDLY SAW NO SIGN OF DEVICE INTERVENTION AS PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENTINEL | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ANGEION CORP | 2010 | 9630301B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Death |