FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1191538
·
Received September 26, 2008
Report
- Report Number
- 1644487-2008-02160
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 27, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT HIS DELL X5 HANDHELD COMPUTER WAS HAVING ISSUES WITH THE SCREEN FREEZING ON MULTIPLE OCCASIONS ON THE "INTERROGATION SUCCESSFUL" SCREEN. HE SAYS HE HAS DONE HARD RESETS, SOFT RESETS, AND REMOVED THE FLASHCARD AND IT WILL WORK FOR A WHILE BUT THEN FREEZES AGAIN. PRODUCT HAS BEEN REQUESTED, BUT HAS NOT BEEN RETURNED TO MANUFACTURER TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | NONE | LYJ | CYBERONICS, INC. | 250 | 523505 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |