BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1202207 · Received October 16, 2008

    Report

    Report Number
    1644487-2008-02487
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE POWER LIGHT WOULD NOT COME ON WHEN RESET BUTTONS WERE PRESSED ON THE VNS PROGRAMMING WAND. TROUBLESHOOTING WAS DONE OVER THE PHONE BY MFR AND REPORTER WAS TOLD TO CHANGE THE BATTERY AND SEE IF WAND WOULD WORK THEN. REPORTER NEVER CALLED BACK TO INDICATE WHETHER PROBLEM WAS SOLVED. ALL ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING WAND LYJ CYBERONICS, INC. 201

    Patients

    Seq Age Sex Outcome Treatment
    1