BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1172206 · Received September 11, 2008

    Report

    Report Number
    1644487-2008-02240
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    February 1, 2008
    Report Date
    August 12, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HAND HELD SCREEN WOULD CONTINUALLY FREEZE UPON SUCCESSFUL INTERROGATION OF VNS PATIENTS DEVICES. THE PHYSICIAN WOULD REMOVE AND RESEAT THE FLASHCARD, AND THE FREEZING SCREEN WOULD TEMPORARILY RESOLVE. THE PHYSICIAN REQUESTED A NEW HAND HELD BE SHIPPED TO REPLACE THE NON-WORKING DEVICE. THE NON-WORKING HAND HELD AND SOFTWARE WERE RETURNED TO MANUFACTURER FOR ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE FLASHCARD, AND THE REPORTED COMPLAINT COULD NOT BE DUPLICATED WITH THE SYSTEM IN ITS "AS RECEIVED" CONDITION. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO SPECIFICATIONS. IT WAS IDENTIFIED THAT UNDER CERTAIN CONDITIONS, THE HAND HELD SCREEN CAN FREEZE AFTER AN INTERROGATION IS PERFORMED. AFTER THE ANOMALY WAS INDUCED BY CREATING THE SPECIFIC CONDITIONS, THE REPORTED FREEZING SCREEN COMPLAINT WAS VERIFIED. ANALYSIS OF THE HAND HELD REVEALED NO ANOMALIES, AND THE DEVICE PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. MODEL 250 523502

    Patients

    Seq Age Sex Outcome Treatment
    1