FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1212581
·
Received October 24, 2008
Report
- Report Number
- 1644487-2008-02571
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- January 1, 2008
- Report Date
- September 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER THAT THE VNS PATIENT WAS REFERRED FOR A BATTERY REPLACEMENT DUE TO END OF SERVICE. FOLLOW-UP REVEALED THAT THE BATTERY REPLACEMENT WAS ACTUALLY BECAUSE THE PATIENT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY. DIAGNOSTICS PERFORMED ON THE DEVICE REVEALED PROPER DEVICE FUNCTION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT'S REPORTED EVENTS HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 5692 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |