BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2101707 · Received May 11, 2011

    Report

    Report Number
    1644487-2011-01061
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN IS UNABLE TO GET THE SERIAL ADAPTOR TO CONNECT TO THE HANDHELD. IT WAS CONFIRM THAT THE ARROWS WERE FACING UP AND THE SIDES WERE DEPRESSED BUT THE ISSUE DID NOT RESOLVE. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 863936

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR