FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1071687
·
Received July 8, 2008
Report
- Report Number
- 1644487-2008-01546
- Event Type
- Malfunction
- Date Received
- July 8, 2008
- Date of Event
- July 18, 2006
- Report Date
- June 19, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENTS' GENERATOR HAD BEEN REPLACED DUE TO END OF SERVICE. PRE-OPERATIVE DIAGNOSTIC TESTS REVEALED THAT THE END OF SERVICE INDICATOR WAS SET TO 'YES'. THE EXPLANTED GENERATOR WAS RETURNED TO MANUFACTURER FOR ANALYSIS. ANALYSIS PERFORMED ON THE GENERATOR REVEALED THAT TWO COMPONENTS WERE OUT OF SPECIFICATION; THE Q9 TRANSISTOR AND THE R35 RESISTOR. LABORATORY ANALYSIS REVEALED THAT THESE OUT OF SPECIFICATION COMPONENTS COULD HAVE POTENTIALLY HAVE BEEN A CONTRIBUTING FACTOR TO THE END OF SERVICE EVENT. HOWEVER, A BATTERY LIFE CALCULATION WAS PERFORMED WITH AVAILABLE PROGRAMMING HISTORY AND SUPPORTED THAT THE GENERATOR HAD LIKELY REACHED NORMAL OF SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 1041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |