BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1970054 · Received January 14, 2011

    Report

    Report Number
    1644487-2011-00060
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    October 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON'S DELL X50 HANDHELD IS SHOWING ON THE HANDHELD SCREEN THAT THE BATTERY LATCH IS OPEN, HOWEVER, THE LATCH WAS REPORTED TO BE IN THE LOCK POSITION. THE MANUFACTURER REPRESENTATIVE TRAVELED TO THE SITE WHERE A HARD RESET WAS PERFORMED, AND THE BATTERY LATCH WAS POSITIONED IN THE LOCK POSITION, AND THE SCREEN WAS STILL SHOWING THAT THE LATCH WAS OPEN. THE HANDHELD WAS REPLACED, AND GOOD FAITH ATTEMPTS TO OBTAIN THE NON-WORKING HANDHELD FOR ANALYSIS HAVE BEEN MADE, BUT THE DEVICE HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 675293

    Patients

    Seq Age Sex Outcome Treatment
    1