FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1197622
·
Received October 13, 2008
Report
- Report Number
- 1644487-2008-02483
- Event Type
- Malfunction
- Date Received
- October 13, 2008
- Date of Event
- September 15, 2008
- Report Date
- September 15, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN WAS EXPERIENCING AN ONGOING ISSUE WITH HIS HANDHELD DEVICE SCREEN FREEZING. THE PHYSICIAN PERFORMED A SOFT RESET WHICH RESOLVED THE ISSUE. GOOD FAITH ATTEMPTS TO HAVE TO HANDHELD DEVICE RETURNED TO CYBERONICS, INC. FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |