FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1970046
·
Received January 14, 2011
Report
- Report Number
- 1644487-2011-00050
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- November 11, 2003
- Report Date
- December 15, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD: ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING A REVIEW OF THE VNS PT'S DEVICE PROGRAMMING AND DIAGNOSTIC HISTORY, IT WAS NOTED THAT THE PROGRAMMED SETTINGS HAD BEEN CHANGED TO UNINTENDED SETTINGS DUE TO AN INTERRUPTED SYSTEM DIAGNOSTIC TEST THAT WAS PERFORMED AT THE OFFICE VISIT. THE DEVICE SETTINGS WERE CHANGED AT THE OFFICE VISIT, HOWEVER, THE OFF TIME WAS PROGRAMMED TO 30 MINUTES RATHER THAN THE INTENDED 0.5 MINUTES. THE NEXT TIME THE PT WAS SEEN WAS ALMOST A YEAR LATER, WHERE THE DEVICE OFF TIME WAS RE-PROGRAMMED TO 5 MINUTES.
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 | 54 YR |