FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1822472
·
Received August 26, 2010
Report
- Report Number
- 1644487-2010-01955
- Event Type
- Injury
- Date Received
- August 26, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 27, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PT EXPERIENCED AN INCREASE IN SEIZURE ACTIVITY OVER THE RECENT MONTHS. THERE WERE NO SETTING CHANGES WHICH PRECEDED THE ONSET OF THE INCREASE IN SEIZURES, AND THERE WERE NO OTHER CAUSAL OR CONTRIBUTORY FACTORS TO THE INCREASE IN SEIZURES. THE NEUROLOGIST HAS REFERRED THE PT TO A SURGERY TO REPLACE THE GENERATOR AND POSSIBLY REPLACE THE LEAD. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO IS UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 009441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention |