FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2021808
·
Received February 25, 2011
Report
- Report Number
- 1644487-2011-00352
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- March 19, 2001
- Report Date
- February 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
Description of Event or Problem · 1
MFR REVIEW OF PROGRAMMING HISTORY REVEALED AN INTERRUPTED SYSTEMS DIAGNOSTICS TEST OCCURRED ON (B)(6) 2004 WHICH CAUSED THE SETTINGS TO CHANGE. THE CHANGE WAS NOT NOTED UNTIL (B)(6) 2004, WHEN THE SETTINGS WERE CORRECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |