FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 1921031
·
Received December 9, 2010
Report
- Report Number
- 1644487-2010-02752
- Event Type
- Malfunction
- Date Received
- December 9, 2010
- Date of Event
- August 5, 2010
- Report Date
- November 9, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED BY SURGEON THAT THE PATIENT HAD THEIR GENERATOR EXPLANTED DUE TO END OF SERVICE. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER FOR DEVICE EVALUATION. PRODUCT ANALYSIS WAS PERFORMED THAT CONFIRMED THE END OF SERVICE CONDITION. ANALYSIS INDICATED THERE WAS AN INCREASED CURRENT CONSUMPTION FOR THE DEVICE, POTENTIALLY CONTRIBUTING TO A PREMATURE END OF LIFE CONDITION. THE INCREASED CURRENT CONSUMPTION WAS ISOLATED TO A LEAKY CAPACITOR (C6). WITH THE CAPACITOR SUBSTITUTION FOR C6, THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102R | LYJ | CYBERONICS, INC. | 102R | 011296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |