FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1172197
·
Received September 11, 2008
Report
- Report Number
- 1644487-2008-02212
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- January 1, 2008
- Report Date
- August 14, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A SITE'S HANDHELD WAS NOT WORKING. IT WOULD FREEZE AT INTERROGATION. ALSO RECEIVED AN SQL ERROR. SOFT AND HARD RESETS WERE PERFORMED AND IT STILL WOULDN'T WORK. PRODUCT ANALYSIS IS PENDING ON THE HANDHELD AND SOFTWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 523504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |