FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1172607
·
Received September 19, 2008
Report
- Report Number
- 1644487-2008-02254
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- January 15, 2002
- Report Date
- August 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE REPORTER INDICATED THAT AN EXPLANTED VNS GENERATOR, WHICH WAS CONFIRMED TO BE AT END OF SERVICE (EOS), EXHIBITED AN "OUT-OF-LIMIT (HIGH) SUPPLY CURRENT 1MA" DURING PRODUCT ANALYSIS. LATER, THIS ANALYSIS REVEALED THAT THE EVENT WAS DUE TO A SELECTABLE VALUE R35 RESISTOR. THOUGH THE OUT-OF-LIMIT SUPPLY CURRENT COULD HAVE POTENTIALLY BEEN A CONTRIBUTING FACTOR TO THE EOS OF THE DEVICE, THE REMAINING BATTERY LONGEVITY WAS CALCULATED TO BE -2.38 CONFIRMING THAT EOS WAS AN EXPECTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |