FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 103
MDR report key: 1973649
·
Received January 18, 2011
Report
- Report Number
- 1644487-2011-00073
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- December 20, 2010
- Report Date
- December 20, 2010
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS PATIENT'S GENERATOR WAS REPORTED TO BE MAKING A BEEPING SOUND AT 11:56 PM EVERY NIGHT PER THE PATIENT'S FAMILY, AND THAT THE PATIENT WOULD HAVE A SEIZURE AT THIS TIME. VNS DIAGNOSTICS WERE REPORTED AS NORMAL, AND A DEVICE MALFUNCTION IS NOT SUSPECTED. THE VNS GENERATOR DOES NOT HAVE ANY AUDIBLE COMPONENTS AND IS UNABLE TO PRODUCE NOISE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS INC | 103 | 201083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |