FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1213117
·
Received October 23, 2008
Report
- Report Number
- 1644487-2008-02561
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- September 26, 2008
- Report Date
- September 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE RPTR INDICATED THAT SHE WAS HAVING SCREEN FREEZE ISSUES WITH HER DELL X50 HAND HELD DEVICE AND THAT TROUBLESHOOTING STEPS WOULD NOT RESOLVE THE ISSUE. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | UNKNOWN | MUZ | CYBERONICS, INC. | MODEL 250 | 537101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |