FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1052078
·
Received May 20, 2008
Report
- Report Number
- 1644487-2008-01180
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 23, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A DELL HANDHELD COMPUTER'S SCREEN WAS FREEZING. RESETTING THE DEVICE RESOLVES THE ISSUE, BUT IT CONTINUES TO OCCUR. THE PRODUCT HAS BEEN RETURNED TO THE MFR FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |