FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1831826
·
Received September 8, 2010
Report
- Report Number
- 1644487-2010-02042
- Event Type
- Malfunction
- Date Received
- September 8, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 1, 2010
- 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 THAT A PHYSICIAN'S DELL X5 HANDHELD DEVICE WOULD FREEZE DURING INTERROGATION. THE FROZEN SCREEN COULD BE RESOLVED PERFORMING A SOFT RESET. THE PHYSICIAN DID NOT REQUEST A REPLACEMENT AS THE HANDHELD COULD BE USED WITHOUT ISSUE AFTER PERFORMING THE SOFT RESET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521413 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |