FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 861006
·
Received June 6, 2007
Report
- Report Number
- 1644487-2007-00767
- Event Type
- Death
- Date Received
- June 6, 2007
- Date of Event
- January 8, 2007
- Report Date
- May 7, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT A VNS PT HAD DIED DUE TO A "SEIZURE DISORDER ". HE INDICATED THAT THE DEATH WAS RELATED TO SUDEP, "BECAUSE EVERYTHING ELSE HAS BEEN RULED OUT." HE DID NOT BELIEVE THAT THE VNS CAUSED OR CONTRIBUTED TO THE PT'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |