FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1744436
·
Received June 30, 2010
Report
- Report Number
- 1644487-2010-01520
- Event Type
- Death
- Date Received
- June 30, 2010
- Date of Event
- July 17, 2007
- Report Date
- June 17, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PASSED AWAY ON (B)(6) 2007. THE CAUSE OF DEATH IS UNK AT THIS TIME. ATTEMPTS FOR FURTHER INFO 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 | 7519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Death |