FDA Adverse Event
Death
Summary report: N
NCP PULSE GENERATOR
MDR report key: 421687
·
Received October 9, 2002
Report
- Report Number
- 1644487-2002-00451
- Event Type
- Death
- Date Received
- October 9, 2002
- Date of Event
- June 22, 2002
- Report Date
- September 9, 2002
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT PT PASSED AWAY DUE TO ASPIRATION. THE PT REPORTEDLY ASPIRATED IN THEIR SLEEP AND WAS FOUND DEAD IN THE MORNING. THE PT WAS LAST SEEN BY THE PHYSICIAN IN 05/02 AND WAS RECEIVING VNS THERAPY AT THE TIME OF DEATH. NO AUTOPSY WAS PERFORMED AND THE NCP SYSTEM WAS NOT EXPLANTED. THE PT REPORTEDLY HAD A >50% REDUCTION IN SEIZURES WITH THE NCP SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 3302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Death | LOT NO. 2837. ANTI-EPILEPTIC MEDICATIONS AT TIME| MODEL 300-20 NCP BIPOLAR LEAD, EXPIRE DATE| 04/30/2003, DATE OF MFG 05/02/2001, STERILIZATION| OF DEATH: PHENYTOIN, BENZODIAZEPINE, TOPIRAMATE| (DOSAGES UNKNOWN). |