FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1120742
·
Received August 15, 2008
Report
- Report Number
- 1644487-2008-01926
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 17, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE SITE REQUESTED A BATTERY LIFE CALCULATION WHICH SHOWED THAT THE GENERATOR IS NOT AT END OF SERVICE YET. IT IS UNKNOWN IF THE INCREASE IN SEIZURES IS ABOVE, BELOW, OR AT PREVNS BASELINE LEVELS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |