FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1905608
·
Received November 19, 2010
Report
- Report Number
- 1644487-2010-02574
- Event Type
- Injury
- Date Received
- November 19, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 2, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A NEUROLOGIST THAT THE VNS PT HAS HAD AN INCREASE IN SEIZURE. THE MD ATTRIBUTED THE PT'S INCREASE IN SEIZURES TO VNS DEVICE BEING AT END OF SERVICE. THE MD DID NOT KNOW THE FREQUENCY OF PT'S SEIZURES BEFORE VNS WAS IMPLANTED. THE PHYSICIAN STATED THAT THE PT WILL BE REFERRED TO A SURGEON TO HAVE HER GENERATOR REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 009493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |