FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 754586
·
Received August 28, 2006
Report
- Report Number
- 1644487-2006-00315
- Event Type
- Death
- Date Received
- August 28, 2006
- Date of Event
- July 26, 2006
- Report Date
- August 22, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE FAILURE.
Description of Event or Problem · 1
REPORTER INDICATED THAT VNS PATIENT HAD PASSED AWAY. TREATING PHYSICIAN INDICATED THE CAUSE OF DEATH WAS MOST LIKELY SUDEP (SUDDEN UNEXPLAINED DEATH IN EPILEPSY). TREATING PHYSICIAN INDICATED THAT THE NCP SYSTEM WAS NOT RELATED TO THE CAUSE OF DEATH. IT WAS REPORTED THAT AN AUTOPSY IS PENDING AND DISPOSITION OF THE NCP SYSTEM IS UNKNOWN AT THIS TIME. THERE IS NO INDICATION THAT THE DEVICE WAS NOT FUNCTIONING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | LYJ | CYBERONICS, INC. | 102 | 14277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Death | LORAZEPAM| FELBATOL| FELBAMATE| LAMOTRIGINE| DIAZEPAM |