FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1132732
·
Received August 21, 2008
Report
- Report Number
- 1644487-2008-01972
- Event Type
- Malfunction
- Date Received
- August 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 24, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A DELL HANDHELD DEVICE WAS DISPLAYING MULTIPLE TIME VALUES ON THE MAGNET ACTIVATIONS DISPLAY. NO FUNCTIONAL DEFICIENCIES WERE REPORTED. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN AND ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
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 |