BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1832098 · Received September 3, 2010

    Report

    Report Number
    1644487-2010-02020
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    May 10, 2006
    Report Date
    August 6, 2010
    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

    VNS PROGRAMMING HISTORY RECEIVED FROM THE REPORTER REVEALED THAT AN INTERRUPTED SYSTEMS DIAGNOSTICS TEST HAD CAUSED THE VNS SETTINGS TO CHANGE AT A PATIENT'S INITIAL IMPLANT SURGERY ON (B)(6) 2006. THE VNS WAS REINTERROGATED BUT THE CHANGE IN SETTINGS WAS NOT NOTED. THIS RESULTED IN THE PATIENT LEAVING THE SURGERY WITH UNINTENDED SETTINGS OF 1MA EVERY 60 MINUTES. THE VNS WAS LATER PROGRAMMED TO THE INTENDED SETTINGS ON (B)(6)2006.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR