FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1081929
·
Received July 23, 2008
Report
- Report Number
- 1644487-2008-01676
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THEIR (B) (4) HANDHELD WILL TURN ON BUT THE SCREEN IS FROZEN. THE HANDHELD CONTAINED (B) (4) PROGRAMMING SOFTWARE. GOOD FAITH ATTEMPTS ARE BEING MADE FOR THE PRODUCT RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |