BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1760911 · Received July 14, 2010

    Report

    Report Number
    1644487-2010-01622
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE SITE THAT THEY COULD NOT INTERROGATE VNS PATIENTS WITH THEIR PROGRAMMING SYSTEM. TROUBLESHOOTING STEPS WERE PERFORMED, AND IT WAS NOTED THAT THE ISSUE LIED IN THE HANDHELD SERIAL CABLE THAT WAS CAUSING COMMUNICATION ERRORS. HANDHELD WAS RETURNED TO MANUFACTURER FOR ANALYSIS. ANALYSIS IS CURRENTLY IN PROGRESS FOR THE RETURNED HANDHELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 54080

    Patients

    Seq Age Sex Outcome Treatment
    1