FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2161844
·
Received July 8, 2011
Report
- Report Number
- 1644487-2011-01535
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 10, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS HAVING INCREASED SEIZURE ACTIVITY. IT WAS ALSO NOTED THAT THE PT HAS HAD HER VNS DISABLED FOR APPROXIMATELY 2 MONTHS BECAUSE SHE WAS "UNABLE TO TOLERATE VNS EVEN AT THE LOWEST OUTPUT CURRENT." IT IS UNK WHEN THE INCREASE IN SEIZURES BEGAN AND IF THEY ARE RELATED TO VNS THERAPY. THE PT HAS REQUESTED THAT HER VNS BE REMOVED DUE TO THE TOLERANCE ISSUES. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 012303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention |