BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1840029 · Received September 15, 2010

    Report

    Report Number
    1644487-2010-02099
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEONS DELL X5 HAND HELD WOULD NOT TURN ON. THE SURGEON EXPLAINED THAT THE HAND HELD HAS BEEN PLUGGED IN FOR A FEW DAYS TO CHARGE, AND IT WOULD NOT TURN ON. IN ADDITION, THE MFR REP WENT TO THE SITE TO TROUBLESHOOT AND THE SAME PROBLEM WAS OBSERVED. THE HAND HELD WAS RETURNED TO THE MFR FOR ANALYSIS, HOWEVER, THE DEVICE WAS RETURNED WITHOUT THE AC ADAPTER CABLE. PRODUCT ANALYSIS OF THE HAND HELD IS CURRENTLY UNDERWAY. GOOD FAITH ATTEMPTS TO OBTAIN THE AC ADAPTER CABLE ARE ALSO UNDERWAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1