FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1770313
·
Received July 21, 2010
Report
- Report Number
- 1644487-2010-01677
- Event Type
- Injury
- Date Received
- July 21, 2010
- Date of Event
- June 24, 2010
- Report Date
- June 24, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES AND WOULD BE REFERRED FOR A PROPHYLACTIC GENERATOR REVISION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN HAS BEEN UNSUCCESSFUL TO DATE. THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED AND A BATTERY LIFE CALCULATION WAS PERFORMED INDICATING THAT THE DEVICE WAS NOT AT END OF SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 4818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |