FDA Adverse Event
Death
Summary report: N
NCP PULSE GENERATOR
MDR report key: 475590
·
Received August 1, 2003
Report
- Report Number
- 1644487-2003-00457
- Event Type
- Death
- Date Received
- August 1, 2003
- Date of Event
- June 27, 2003
- Report Date
- July 2, 2003
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE PATIENT HAS PASSED AWAY. EXACT CAUSE OF DEATH IS UNKNOWN AT THIS TIME. REPORTER INDICATED THAT THE NCP SYSTEM IS NOT RELATED TO THE CAUSE OF DEATH, AND THAT THE PATIENT HAD OTHER MEDICAL PROBLEMS. AN AUTOSPY WAS PERFORMED. THE PATIENT WAS SEEN BY THE PHYSICIAN APPROXIMATELY ONE WEEK PRIOR TO THE PATIENT'S DEATH. THERE IS NO EVIDENCE AT THIS TIME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED 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 | 7151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Death | MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE 1/31/01,| DATE OF MFG 1/8/1999, STERILIZATION LOT #19323C.| MEDICATIONS AT TIME OF DEATH: KEPPRA - 1500 MG,BID| TRILEPTAL, CARBAZEPINE, LEVETIRACETUM. |