FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2230803
·
Received August 23, 2011
Report
- Report Number
- 1644487-2011-01956
- Event Type
- Injury
- Date Received
- August 23, 2011
- Date of Event
- June 28, 2011
- Report Date
- July 27, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT A VNS PT HAD A GENERATOR REPLACEMENT DUE TO INCREASE SEIZURES. CLINIC NOTES WERE OBTAINED BY MFR WHICH INDICATED THAT PT WAS RECENTLY ADMITTED TO HOSP DUE TO SEIZURE STATUS AND SEIZURE INCREASE. THE NEUROLOGIST STARTED THE PT ON VIMPET MEDICATION WHICH HELPED WITH SEIZURE REDUCTION SLIGHTLY. THE PHYSICIAN ALSO INDICATED THAT PT'S GENERATOR DOES NOT RESPOND TO MAGNET ACTIVATION AND SUSPECTED THE BATTERY IS DEPLETED. THE PT IS AT RISK OF DEATH DUE TO POOR SEIZURE CONTROL PER THE PHYSICIAN. A REVISION SURGERY IS LIKELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 8457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention |