FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2083255
·
Received May 4, 2011
Report
- Report Number
- 1644487-2011-00997
- Event Type
- Death
- Date Received
- May 4, 2011
- Date of Event
- July 5, 2010
- Report Date
- April 12, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A NEUROLOGIST THAT A VNS PATIENT PASSED AWAY ON (B)(6) 2010. THE TREATING NEUROLOGIST; HOWEVER, DID NOT KNOW THE CAUSE OF DEATH AND ITS RELATION TO VNS DEVICE. FUNERAL HOME INDICATED THAT VNS DEVICE WAS BURIED WITH THE DECEASED. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFO REGARDING PT'S INFO BY OBTAINING DEATH CERTIFICATE HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 201228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Death |