FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1096206
·
Received July 31, 2008
Report
- Report Number
- 1644487-2008-01741
- Event Type
- Malfunction
- Date Received
- July 31, 2008
- Date of Event
- January 17, 2008
- Report Date
- July 4, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE TREATING PHYSICIAN THAT THE VNS PT'S GENERATOR WAS FOUND TO BE PROGRAMMED AT OUTPUT CURRENT 0MA DURING THE PERIOD FOR SIX MONTHS IN 2008 AFTER A LEAD TEST PERFORMED THE FIRST DAY. THE PT WAS PROGRAMMED AT 0.5 MA ON THE LAST DAY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE PROGRAMMING ANOMALY EVENT ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |