FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1662674
·
Received April 16, 2010
Report
- Report Number
- 1644487-2010-00940
- Event Type
- Death
- Date Received
- April 16, 2010
- Date of Event
- March 1, 2010
- Report Date
- March 19, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT HAD DIED DUE TO UNKNOWN REASON. PATIENT'S BLC WAS PERFORMED, AND IT WAS OBSERVED THAT PATIENT HAD NEGATIVE YEARS OF BATTERY REMAINING, INDICATING THAT THE DEVICE IS LIKELY AT OR NEARING END-OF-SERVICE. THE PHYSICIAN DID NOT HAVE ANY ADDITIONAL INFORMATION AT THE MOMENT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL. THE CAUSE OF DEATH IS UNKNOWN AT THE MOMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 010850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Death |