FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2101949
·
Received May 18, 2011
Report
- Report Number
- 1644487-2011-01109
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- October 22, 2009
- Report Date
- April 20, 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
MANUFACTURER REVIEW OF A PT'S VNS PROGRAMMING HISTORY IDENTIFIED THAT A FAULTED SYSTEMS DIAGNOSTICS TEST OCCURRED ON (B)(6) 2009 WHICH CAUSED THE SETTINGS TO CHANGE. THERE WAS NO FINAL INTERROGATION PERFORMED TO VERIFY SETTINGS. THE SETTINGS WERE CORRECTED ON (B)(6) 2009.
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 | 66 YR |