FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1071715
·
Received July 9, 2008
Report
- Report Number
- 1644487-2008-01567
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 9, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE SITE PERFORMED SYSTEM DIAGNOSTIC TESTS ON SEVERAL VNS PATIENTS' DEVICES, THE OFF TIME WAS FOUND TO BE SET TO 60 MINUTES. AS A RESULT, THE SETTINGS HAD TO BE CHANGED BACK TO THE INTENDED SETTINGS. ATTEMPTS TO OBTAIN PROGRAMMING AND DIAGNOSTIC HISTORY FOR REVIEW HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |