FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2063864
·
Received March 23, 2011
Report
- Report Number
- 1644487-2011-00612
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- January 1, 2009
- Report Date
- March 7, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING A REVIEW OF THE PT'S PROGRAMMING HISTORY, IT WAS FOUND THAT THE PT'S SETTINGS WERE SET TO UNINTENDED SETTINGS DUE TO AN INTERRUPTED SYSTEM DIAGNOSTIC TEST. PT DEVICE WAS RESET TO INTENDED SETTINGS ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |