FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2043570
·
Received March 28, 2011
Report
- Report Number
- 1644487-2011-00655
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- July 11, 2006
- Report Date
- March 25, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING MFR REVIEW OF A VNS PT'S PROGRAMMING HISTORY, IT WAS NOTED A FAULTED SYSTEMS DIAGNOSTICS TEST OCCURRED ON (B)(6) 2006, WHICH CAUSED THE SETTINGS TO CHANGE TO SYSTEMS DIAGNOSTICS DEFAULT SETTINGS. THE CHANGE WAS NOTED UPON REINTERROGATION OF THE PT'S GENERATOR AND ALL SETTINGS WERE CORRECTED EXCEPT FOR THE OFF TIME, WHICH REMAINED AT 60 MINUTES. THE OFF TIME WAS NOT CORRECTED UNTIL (B)(6) 2006.
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 | 44 YR |