FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1153204
·
Received September 5, 2008
Report
- Report Number
- 1644487-2008-02154
- Event Type
- Death
- Date Received
- September 5, 2008
- Date of Event
- February 4, 2008
- Report Date
- August 21, 2008
- 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
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PT WAS FOUND DECEASED IN HIS HOME. THE REPORTER INDICATED THAT THOUGH THE CAUSE OF DEATH WAS STILL UNK, HE BELIEVED THAT THE EVENT TO WAS DUE TO CARDIAC ARREST AND NOT RELATED TO VNS THERAPY. DEVICE DIAGNOSTICS PERFORMED SEVEN DAYS BEFORE THE PT'S DEATH INDICATED PROPER DEVICE FUNCTION. THE PT'S DEVICE WAS NOT RETURNED TO THE MFR AS IT WAS NOT EXPLANTED BEFORE BURIAL. NO DEVICE FAILURES ARE SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 010093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |