FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1198387
·
Received October 10, 2008
Report
- Report Number
- 1644487-2008-02475
- Event Type
- Malfunction
- Date Received
- October 10, 2008
- Date of Event
- September 10, 2008
- Report Date
- September 11, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT'S VNS DEVICE WAS FOUND TO BE SET TO 0MA AT A ROUTINE OFFICE VISIT. THE PHYSICIAN INDICATED THIS WAS THE FIRST TIME SHE HAD SEEN THE PT, AND IT HAD BEEN A WHILE SINCE THE PT HAD BEEN SEEN BY ANY OTHER PHYSICIAN. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |