FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2211107
·
Received August 5, 2011
Report
- Report Number
- 1644487-2011-01797
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- August 1, 2009
- Report Date
- July 6, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS REVIEWING THE PROGRAMMING HISTORY AND HE STATES THE PT WAS AT 2.25/20/250/30/3 FROM (B)(6) 2007 UNTIL (B)(6) 2009 AND THEN WAS RESET TO 0.25/30/500/30/5, BUT HE DOES NOT KNOW WHY OR FOR HOW LONG. HE INTERROGATED THE PT AND WAS SUCCESSFUL READING HER CURRENT SETTINGS AT 0.25/30/500/30/5/0/60/500. IT IS CURRENTLY UNK WHY THE PT WAS SET TO THESE SETTINGS OR IF THERE WAS A SOFTWARE ERROR. 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR |