FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1067007
·
Received June 25, 2008
Report
- Report Number
- 1644487-2008-01465
- Event Type
- Malfunction
- Date Received
- June 25, 2008
- Date of Event
- December 1, 2007
- Report Date
- June 4, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS PATIENT WAS INTERROGATED AND FOUND TO BE SET TO 0MA. THE PATIENT WAS ASYMPTOMATIC AND WAS SUCCESSFULLY REPROGRAMMED TO THE APPROPRIATE SETTINGS. THE REPORTER STATED HE IS NOT SURE IF A FINAL VNS INTERROGATION WAS DONE AT THE PATIENT'S LAST VISIT SIX MONTHS PRIOR. ATTEMPTS FOR PROGRAMMING HISTORY TO ESTABLISH IF A PROGRAMMING ANOMALY OCCURRED ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |