FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1220050
·
Received October 31, 2008
Report
- Report Number
- 1644487-2008-02634
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 1, 2008
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.
Description of Event or Problem · 1
REPORTER INDICATED THAT THEIR (B) (4) HANDHELD COMPUTER IS HAVING PROBLEMS WITH THE SCREEN FREEZING. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. PRODUCT WAS RETURNED TO MANUFACTURER, BUT ANALYSIS IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | NONE | LYJ | CYBERONICS INC | MODEL 250 | 523506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |