FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1052407
·
Received May 23, 2008
Report
- Report Number
- 1644487-2008-01200
- Event Type
- Death
- Date Received
- May 23, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT VNS THERAPY PT DIED DUE TO UNKNOWN CAUSES. IT WAS REPORTED THAT THE PT'S DEVICE WAS DEACTIVATED AT THE TIME OF DEATH, YET THE FULL RELATIONSHIP BETWEEN THE DEATH AND VNS THERAPY REMAINS UNKNOWN. EXACT DATE OF DEATH IS ALSO UNKNOWN AT THIS TIME. GOOD FAITH ATTEMPTS FOR FURTHER INFO ARE CURRENTLY BEING MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 013177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |