FDA Adverse Event
Death
Summary report: N
NCP PULSE GENERATOR
MDR report key: 448112
·
Received March 13, 2003
Report
- Report Number
- 1644487-2003-00058
- Event Type
- Death
- Date Received
- March 13, 2003
- Date of Event
- January 8, 2003
- Report Date
- February 12, 2003
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
VNS PATIENT HAD PASSED AWAY. IT WAS REPORTED THAT THE PATIENT HAD VARIOUS CO-MORBIDITIES AND DIED OF NATURAL CAUSES. THE EXACT CAUSE OF DEATH IS UNKNOWN AT THIS TIME. NO AUTOPSY WAS PERFORMED AND THE NCP SYSTEM WAS NOT EXPLANTED. 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 | 27 YR | Death | MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE 6/30/01,| ACID CLONAZEPAM - PRN, DIASTAT - PRN.| IMPLANTED 1999.| MEDICATIONS AT TIME OF DEATH: VALPROATE/VALPROIC| DATE OF MFG 6/2/1999, STERILIZATION LOT NO. 23535C |