FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1963274
·
Received January 13, 2011
Report
- Report Number
- 1644487-2011-00057
- Event Type
- Injury
- Date Received
- January 13, 2011
- Date of Event
- December 17, 2010
- Report Date
- December 17, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PT IS EXPERIENCING AN INCREASE IN SEIZURES AND THE NEUROLOGISTS BELIEVES THE VNS GENERATOR IS APPROACHING END OF SERVICE. THE PHYSICIAN REPORTED THAT HE WAS ABLE TO PERFORM SYSTEM AND NORMAL MODE DIAGNOSTICS THAT WERE NORMAL. A BATTERY LIFE CALCULATION WAS PERFORMED THAT ESTIMATED APPROXIMATELY 0.13 YEARS UNTIL END OF SERVICE. ATTEMPTS FOR FURTHER INFORMATION 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 | 7910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Female |