FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1730056
·
Received June 18, 2010
Report
- Report Number
- 1644487-2010-01441
- Event Type
- Injury
- Date Received
- June 18, 2010
- Date of Event
- May 19, 2010
- Report Date
- May 19, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT WAS HAVING THREE SEIZURES A WEEK AND THEIR SEIZURE MEDICATION VIMPAT WAS INCREASED. IT IS UNKNOWN IF THEIR THREE SEIZURES A WEEK WAS ABOVE OR BELOW THEIR PREVNS SEIZURE RATE. GOOD FAITH ATTEMPTS HAVE BEEN UNSUCCESSFUL TO DATE...
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 12407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |