FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL 101
MDR report key: 776249
·
Received November 2, 2006
Report
- Report Number
- 1644487-2006-00413
- Event Type
- Other
- Date Received
- November 2, 2006
- Date of Event
- July 20, 2006
- Report Date
- September 27, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT VNS PT 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. NO AUTOPSY WILL BE PERFORMED. THERE IS NO INDICATION THAT THE DEVICE WAS NOT FUNCTIONING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | LYJ | CYBERONICS, INC. | 101 | 4813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |