FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2202644
·
Received August 5, 2011
Report
- Report Number
- 1644487-2011-01779
- Event Type
- Death
- Date Received
- August 5, 2011
- Date of Event
- March 23, 2011
- Report Date
- July 11, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PATIENT PAST AWAY. THE CAUSE OF DEATH IS UNKNOWN BUT WAS MORE THAN LIKELY RELATED TO SEIZURES, THE RELATIONSHIP OF THE DEATH TO VNS IS UNKNOWN. GOOD FAITH ATTEMPTS FOR MORE INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
CAUSE OF DEATH INFORMATION OBTAINED FROM THE NATIONAL DEATH INDEX (NDI) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT'S CAUSE OF DEATH WAS POSSIBLE SUDEP, OTHER AND UNSPECIFIED CONVULSIONS. A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED WHICH DETERMINED THAT THE DEATH MET CRITERIA FOR CLASSIFICATION OF POSSIBLE SUDEP. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 200975 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Death |