FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1203137
·
Received October 17, 2008
Report
- Report Number
- 1644487-2008-02517
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- September 22, 2008
- Report Date
- September 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SCREEN OF HIS DELL X5 HAND HELD DEVICE WOULD FREEZE AFTER PRESSING THE INTERROGATION BUTTON AND THAT TROUBLE SHOOTING STEPS WERE UNABLE TO RESOLVE THE ISSUE. THE PRODUCT WAS RETURNED AND IS CURRENTLY AWAITING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |