FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1963276
·
Received January 13, 2011
Report
- Report Number
- 1644487-2011-00055
- Event Type
- Injury
- Date Received
- January 13, 2011
- Date of Event
- November 22, 2010
- Report Date
- December 14, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA CLINIC NOTES RECEIVED THAT THE PT HAS BEEN EXPERIENCING "MORE SEIZURES THAN EXPECTED." THE PT'S DOSAGE OF KEPPRA HAD BEEN INCREASED AT THE PREVIOUS OFFICE VISIT. THE VNS GENERATOR HAS BEEN REPORTED AS APPROACHING END OF SERVICE; HOWEVER, IT IS UNK IF PROPER STIMULATION IS BEING DELIVERED. NO MEDICATION OR PROGRAMMING CHANGES WERE REPORTED AS CONTRIBUTING TO THE INCREASE. THE RELATIONSHIP OF THE PT'S CURRENT SEIZURE LEVEL COMPARED TO LEVELS PRIOR TO VNS THERAPY IS UNK. SURGERY TO REPLACE THE VNS GENERATOR IS LIKELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 016389 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |