BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1860032 · Received September 17, 2010

    Report

    Report Number
    1644487-2010-02115
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED AGAINST THE SERIAL ADAPTER CABLE.

    Description of Event or Problem · 1

    OUR CONSULTANT WAS NOTIFIED THAT A VNS PATIENT WAS SEEN IN CLINIC AND INTERROGATION WENT THROUGH SUCCESSFULLY, BUT WHEN THE PHYSICIAN WANTED TO INCREASE THE SETTINGS BY 0.25MA, THE HANDHELD COMPUTER HAD PROGRESSED THROUGH ONE BAR AND THEN STOPPED. PROGRAMMING WAS NOT SUCCESSFUL. THE POWER LIGHT WOULDN'T COME ON IN THE PROGRAMMING WAND. THE BATTERY WAS CHANGED IN THE PROGRAMMING WAND AND THE CONSULTANT USED THE SAME PROGRAMMING SYSTEM ON HIS DEMO GENERATOR. IT TOOK A LONGER TIME TO INTERROGATE THAN IT SHOULD HAVE, BUT HE WAS ABLE TO INTERROGATE SUCCESSFULLY. IT WAS NOTED THAT THE SERIAL ADAPTOR WIRE WAS FRAYED AND THE WIRE WAS EVEN EXPOSED. THIS MAY ALSO HAVE CONTRIBUTED TO THE SLOWNESS. GOOD FAITH ATTEMPTS ARE BEING MADE TO OBTAIN THE SERIAL ADAPTER CABLE FOR PRODUCT ANALYSIS. THUS FAR THEY HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 523507

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR