FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 841291
·
Received April 13, 2007
Report
- Report Number
- 1644487-2007-00212
- Event Type
- Other
- Date Received
- April 13, 2007
- Date of Event
- January 1, 2007
- Report Date
- March 22, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- p970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
REPORTER INDICATED THAT THE PATIENT DEATH WAS NOT RELATED TO THE VNS THERAPY SYSTEM.
Description of Event or Problem · 1
REPORTER INDICATED THAT A VNS PATIENT EXPIRED, AND THERE WAS PROBABLE CAUSE TO BELIEVE IT WAS DUE TO SUDEP (SUDDEN UNEXPLAINED DEATH IN EPILEPSY). REPORTER FURTHER INDICATED THAT THE DEATH WAS NOT RELATED TO THE VNS THERAPY SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | LYJ | LYJ | CYBERONICS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |