FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1941222
·
Received December 16, 2010
Report
- Report Number
- 1644487-2010-02814
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- May 12, 2006
- Report Date
- November 17, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD - REVIEW OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY.
Description of Event or Problem · 1
IT WAS OBSERVED DURING THE REVIEW OF THE PT'S PROGRAMMING HISTORY THAT THE PT'S DEVICE WAS INADVERTENTLY PROGRAMMED TO DIFFERENT SETTINGS DUE TO AN INTERRUPTED DIAGNOSTICS TEST. A FINAL INTERROGATION WAS NOT PERFORMED TO CONFIRM PT'S SETTINGS WERE AS INTENDED. THE PT'S SETTING HAS SINCE BEEN CORRECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 364714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR |