BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2102388 · Received May 20, 2011

    Report

    Report Number
    1644487-2011-01147
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 20, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PT'S VNS WAS UNINTENTIONALLY PROGRAMMED OFF DURING AN INTERRUPTED SYSTEMS DIAGNOSTICS TEST. IT WAS IDENTIFIED THAT THE VNS PROGRAMMING WAND BATTERIES WERE VERY WEAK. THE REPORTER WAS ABLE TO REINTERROGATE THE PT THE NEXT DAY AFTER REPLACING THE WAND BATTERIES AND THE VNS SETTINGS WERE CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 840144

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR