FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1191912
·
Received October 1, 2008
Report
- Report Number
- 1644487-2008-02385
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- August 3, 2008
- Report Date
- September 3, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT THE PHYSICIAN'S HAND HELD SCREEN WAS FREEZING AFTER SUCCESSFUL INTERROGATIONS AND AT THE RESULT SCREEN FOLLOWING SYSTEM DIAGNOSTICS TESTS. TROUBLESHOOTING WAS PERFORMED AND THE PROBLEMS CONTINUED TO BE SPORADIC. THE NON-WORKING HANDHELD AND SOFTWARE FLASHCARD HAVE BEEN RETURNED TO THE MFR AND ANALYSIS IS UNDERWAY. A REPLACEMENT HAND HELD WAS SENT TO THE PHYSICIAN AND THE PHYSICIAN HAS NOT ENCOUNTERED ANY ADD'L PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |