FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1757180
·
Received June 18, 2010
Report
- Report Number
- 1644487-2010-01448
- Event Type
- Malfunction
- Date Received
- June 18, 2010
- Date of Event
- October 14, 2005
- Report Date
- May 21, 2010
- 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
IT WAS FOUND DURING REVIEW OF PROGRAMMING HISTORY THAT THE PT'S SETTINGS WERE RESET TO 0 MA ON (B) (6)2005. AT THAT VISIT, GENERATOR DIAGNOSTICS WERE PERFORMED WHICH IS NOT RECOMMENDED AND A FINAL INTERROGATION WAS NOT PERFORMED TO VERIFY SETTINGS. THE RESET WAS NOTICED ON (B) (6)2005, AT WHICH TIME, THE PT'S SETTINGS WERE RESET TO INTENDED SETTINGS. THE CAUSE OF THE RESET IS LIKELY DUE TO THE GENERATOR DIAGNOSTICS BEING PERFORMED AT THE OFFICE VISIT.
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 | 40 YR |