FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1102489
·
Received August 8, 2008
Report
- Report Number
- 1644487-2008-01805
- Event Type
- Injury
- Date Received
- August 8, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 11, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MANUFACTURER THAT THE VNS PATIENT HAD HIS THIRD GENERATOR REPLACEMENT. THE GENERATOR WAS REPLACED BECAUSE OF AN INCREASE IN SEIZURE ACTIVITY. BATTERY LIFE CALCULATION ON THE PATIENT'S GENERATOR REVEALED THAT THE GENERATOR WAS NOT AT END OF SERVICE. DIAGNOSTICS PERFORMED ON THE DEVICE WERE WITHIN NORMAL LIMITED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE PHYSICIAN ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 015852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |