FDA Adverse Event
Death
Summary report: N
INTERNAL DEFIBRILLATOR
MDR report key: 34341
·
Received July 15, 1996
Report
- Report Number
- 34341
- Event Type
- Death
- Date Received
- July 15, 1996
- Date of Event
- July 6, 1996
- Report Date
- July 15, 1996
- Manufacturer
- CARDIAC PACEMAKER, INC.
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FOUND COLLAPSED IN A PARKING LOT NEAR HIS HOME. BROUGHT TO THE EMERGENCY DEPT VIA AMBULANCE. EMERGENCY RESUSCITATION UNSUCCESSFUL. MEDICAL EXAMINER CALLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERNAL DEFIBRILLATOR Implant | INTERNAL DEFIBRILLATOR | LWS | CARDIAC PACEMAKER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Death |