FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL 10X
MDR report key: 853046
·
Received May 18, 2007
Report
- Report Number
- 1644487-2007-00635
- Event Type
- Other
- Date Received
- May 18, 2007
- Date of Event
- April 1, 2007
- Report Date
- April 19, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEATH OCCURRED BUT IS NOT SUSPECTED TO BE RELATED TO VNS THERAPY. DEVICE FAILURE IS NOT SUSPECTED.
Description of Event or Problem · 1
REPORTER INDICATED THAT A PATIENT PASSED AWAY. FROM THE INFORMATION AVAILABLE TO THE TREATIING PHYSICIAN, HE BELIEVES THE CAUSE OF DEATH WAS FROM CHOKING, HOWEVER, THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE IS SUDEP (SUDDEN UNEXPLAINED DEATH IN EPILEPSY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 10X | LYJ | CYBERONICS, INC. | 10X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |