FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2181246
·
Received July 8, 2011
Report
- Report Number
- 1644487-2011-01532
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- April 30, 2007
- Report Date
- July 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METHOD: ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING MFR REVIEW OF A PT'S VNS PROGRAMMING HISTORY IT WAS NOTED A FAULTED SYSTEMS DIAGNOSTICS TEST ON (B)(6) 2007 CAUSED THE SETTINGS TO CHANGE. THE CHANGE IN SETTINGS WAS NOTED AND ALL SETTINGS EXCEPT FOR THE OFF TIME WERE CORRECTED. THE OFF TIME REMAINED AT 60 MINUTES UNTIL (B)(6) 2008 WHEN IT WAS CORRECTED.
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 | 57 YR |