FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2191315
·
Received July 27, 2011
Report
- Report Number
- 1644487-2011-01713
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- 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
IT WAS REPORTED THAT THE PT THINKS HER SETTINGS HAVE REVERTED BACK TO 3 HOURS OFF TIME AND SHE WAS HAVING SOME SIDE EFFECTS (UNSPECIFIED). SHE THINKS THE PHYSICIAN'S HANDHELD WAS ACTING UP WHICH CAUSED THE RESET. THE RESET HAS NOT BEEN CONFIRMED AND THE PT HAS NOT SEEN THE PHYSICIAN YET. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | MUZ | CYBERONICS INC | 250 | 857134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |