BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1970043 · Received January 14, 2011

    Report

    Report Number
    1644487-2011-00026
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON'S DELL X50 POWER CABLE HAS A LOOSE CONNECTION, AND THE HANDHELD WILL SHUT OFF INTERMITTENTLY BUT WHEN THE CABLE IS HELD IN PLACE, THE HANDHELD WILL NOT SHUT OFF. THE SITE WAS SENT A NEW POWER CABLE AND HANDHELD. GOOD FAITH ATTEMPTS TO OBTAIN THE CABLE AND HANDHELD HAVE BEEN MADE, HOWEVER, THE DEVICE HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 715909

    Patients

    Seq Age Sex Outcome Treatment
    1