FDA Adverse Event
Death
Summary report: N
NCP PULSE GENERATOR
MDR report key: 436084
·
Received January 2, 2003
Report
- Report Number
- 1644487-2002-00549
- Event Type
- Death
- Date Received
- January 2, 2003
- Date of Event
- November 18, 2002
- Report Date
- December 4, 2002
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT PT WENT INTO STATUS AND DIED FOUR DAYS POST-IMPLANT. THE PT'S NCP SYSTEM HAD NOT YET BEEN PROGRAMMED TO ON. THERE IS NO EVIDENCE TO DATE THAT THE NCP SYSTEM CAUSED OR CONTIBUTED TO THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 6981 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Death | LOT NO. 4678R.| 11/30/2003, DATE OF MFG 12/03/2001, STERILIZATION| MODEL 300-20 NCP BIPOLAR LEAD, EXPIRE DATE |