BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2152435 · Received June 22, 2011

    Report

    Report Number
    1644487-2011-01405
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN'S HANDHELD WAS FREEZING ON THE "INTERROGATION SUCCESSFUL" SCREEN. A HARD RESET WAS PERFORMED AND THE SCREEN FREEZE RESOLVED. THE OFFICE REQUESTED A REPLACEMENT HANDHELD. 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 868885

    Patients

    Seq Age Sex Outcome Treatment
    1