FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1193202
·
Received October 7, 2008
Report
- Report Number
- 1644487-2008-02438
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- May 6, 2008
- Report Date
- May 20, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REFERENCE MDR NUMBER: 1644487-2008-01396. IT WAS REPORTED THE PT CAME INTO THE OFFICE AND THEIR VNS WAS NOT SET TO INTENDED SETTINGS. PROGRAMMING HISTORY WAS OBTAINED FOR REVIEW. PROGRAMMING HISTORY WAS REVIEWED. A FAULT ERROR RESULTED IN AN INADVERTENT PROGRAMMING CHANGE, AND SUBSEQUENTLY THE PARAMETERS WERE CORRECTED BUT THE OFF TIME WAS LEFT AT 60 MINUTES. IT APPEARS THAT PT LEFT THE OFFICE WITH SUB-THERAPEUTIC SETTINGS.
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 |