FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1172208
·
Received September 11, 2008
Report
- Report Number
- 1644487-2008-02236
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 13, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DELL HANDHELD COMPUTER WOULD NOT FUNCTION WHEN THE PHYSICIAN WAS TRYING TO USE IT DURING AN IMPLANT IN THE OR. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE, AND IT WAS THOUGHT THAT THERE WAS A POSSIBLE BATTERY FAILURE. A WEEK LATER, A COMPANY REP TRIED TROUBLESHOOTING AGAIN ON THE HANDHELD WITH NO REACTION. HOWEVER, FOR NO APPARENT REASON, THE HANDHELD POWERED ON AND APPEARED TO BE FUNCTIONING PROPERLY. THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER AND IS UNDERGOING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 584946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |