FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1070421
·
Received July 3, 2008
Report
- Report Number
- 1644487-2008-01520
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- January 1, 2008
- Report Date
- June 3, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PHYSICIAN'S HANDHELD SCREEN WAS FREEZING DURING INTERROGATION. ONCE HE RE-INSERTS THE FLASHCARD, THE ISSUE RESOLVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | MUZ | CYBERONICS, INC. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |