FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1192117
·
Received October 7, 2008
Report
- Report Number
- 1644487-2008-02426
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- July 23, 2008
- Report Date
- September 8, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURES. THE PHYSICIAN BELIEVES THIS TO BE A RESULT OF THE VNS BATTERY NEARING END OF SERVICE. DIAGNOSTIC TEST RESULTS RUN ON THE DEVICE WERE WITHIN NORMAL LIMITS. SETTINGS WERE ADJUSTED TO INCREASE STIMULATION AND REPLACEMENT SURGERY IS BEING SCHEDULED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 5757 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |