FDA Adverse Event
Malfunction
Summary report: N
RROGRAMMING SOFTWARE
MDR report key: 1190588
·
Received October 6, 2008
Report
- Report Number
- 1644487-2008-02423
- Event Type
- Malfunction
- Date Received
- October 6, 2008
- Date of Event
- September 8, 2008
- Report Date
- September 8, 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
REPORTER INDICATED THAT HIS HANDHELD HAD SCREEN FREEZING ISSUES. ROUTINE TROUBLESHOOTING WAS PERFORMED BUT DID NOT RESOLVE THE ISSUE. THE PHYSICIAN WAS SENT A REPLACEMENT HANDHELD DEVICE. THE DEVICE HAS BEEN RECEIVED BY THE MFR BUT PROD ANALYSIS HAS NOT BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 523498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |