FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1231155
·
Received November 12, 2008
Report
- Report Number
- 1644487-2008-02577
- Event Type
- Malfunction
- Date Received
- November 12, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD HIS VNS GENERATOR REPLACED DUE TO BATTERY DEPLETION. THE EXPLANTED GENERATOR WAS SENT BACK TO THE MANUFACTURER FOR ANALYSIS AND IT WAS FOUND THAT THE RESISTOR IN THE GENERATOR WAS NOT OPTIMAL WHICH MAY HAVE CONTRIBUTED TO THE END OF SERVICE EVENT; HOWEVER, RESULTS OF THE BATTERY LONGEVITY PREDICTION CONFIRMED THAT THE END OF SERVICE CONDITION WAS AN EXPECTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 4136 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |