FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2052675
·
Received April 7, 2011
Report
- Report Number
- 1644487-2011-00738
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 8, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A NEUROLOGIST VIA CLINIC NOTES THAT A VNS PT WAS HAVING MORE SEIZURE ACTIVITY. THE PT STARTED HAVING MORE SEIZURES WHEN DEPAKOTE MEDICATION WAS INCREASED. THE TREATING NEUROLOGIST REFERRED THE PT FOR GENERATOR REPLACEMENT SINCE THE GENERATOR WAS APPROACHING NEAR END OF SERVICE. THE PHYSICIAN INCREASED VNS GENERATOR'S OUTPUT FROM 2.25 MA TO 2.5 MA FOR BETTER SEIZURE CONTROL. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFO REGARDING PT'S SEIZURE INCREASE HAVE BEEN UNSUCCESSFUL TO DATE. ALSO, A REVISION SURGERY FOR GENERATOR REPLACEMENT IS LIKELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 009771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Required Intervention |