FDA Adverse Event
Other
Summary report: N
VNS THERAPY PULSE
MDR report key: 817530
·
Received February 9, 2007
Report
- Report Number
- 1644487-2007-00017
- Event Type
- Other
- Date Received
- February 9, 2007
- Date of Event
- December 30, 2006
- Report Date
- January 10, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PT PASSED AWAY, PROBABLY DUE TO SUDEP (SUDDEN UNEXPLAINED DEATH IN EPILEPSY). THE PT WAS RECEIVING VNS THERAPY AT THE TIME OF DEATH AND THE TREATING PHYSICIAN INDICATED THAT THE CAUSE OF DEATH WAS NOT LIKELY RELATED TO VNS THERAPY. REVIEW OF AVAILABLE PROGRAMMING HISTORY INDICATED THAT THE PT'S LAST KNOWN DEVICE SETTINGS WERE PROGRAMMED IN 2006. NO DIAGNOSTIC TESTING RESULTS WERE AVAILABLE ON THE PROGRAMMING HISTORY REC'D, BUT NO DEVICE MALFUNCTION IS SUSPECTED. AN AUTOPSY HAS BEEN PERFORMED BUT RESULTS ARE UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VNS THERAPY PULSE | PULSE GENERATOR (LVJ) | LYJ | CYBERONICS, INC. | 102 | 14675 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Other |