FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2073697
·
Received April 13, 2011
Report
- Report Number
- 1644487-2011-00806
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- September 22, 2003
- Report Date
- March 15, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING THE REVIEW OF THE PROGRAMMING HISTORY, IT WAS OBSERVED THAT THE GENERATOR WAS PROGRAMMED TO UNINTENDED SETTINGS ON (B)(6) 2003 DUE TO AN INTERRUPTED DIAGNOSTICS TEST. THE PHYSICIAN NOTICED THE CHANGE AND REPROGRAMMED MOST OF THE SETTINGS TO INTENDED SETTINGS, BUT THE OFF TIME WAS NOT REPROGRAMMED AS INTENDED AFTER THE RESET. AT THE NEXT VISIT ON (B)(6) 2003, THE OFF TIME WAS SET BACK TO INTENDED SETTINGS.
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 | 20 YR |