BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1172157 · Received September 11, 2008

    Report

    Report Number
    1644487-2008-02199
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 15, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THAT THE VNS PATIENT'S DEVICE WAS FOUND TO BE SET AT 0 MA AT THE END OF THE FOLLOW-UP VISIT. THE PATIENT'S DEVICE WAS INTERROGATED AT THE BEGINNING OF THE VISIT AND WAS FOUND TO BE PROGRAMMED AT THE INTENDED SETTINGS. DIAGNOSTICS TESTS WERE RUN AND THE DEVICE WAS FOUND TO BE FUNCTIONING WITHIN NORMAL LIMITS. AFTER FINDING THE PATIENT'S DEVICE PROGRAMMED AT 0MA, THE PHYSICIAN TRIED TO SET THE PATIENT BACK TO HIS THERAPEUTIC SETTINGS (1.75 MA), BUT RECEIVED THE WARNING MESSAGE "YOU HAVE SELECTED AN OUTPUT CURRENT CHANGE GREATER THAN 0.25 MA". THE PHYSICIAN WAS HESITANT TO PROGRAM THE PATIENT BACK TO HIS ORIGINAL SETTINGS DUE TO THE WARNING MESSAGE. FOLLOW-UP WITH THE PHYSICIAN REVEALED THAT SETTINGS ON THE PATIENT'S DEVICE ARE BEING PROGRESSIVELY INCREASED AT 1.75 MA. NO OTHER DEVICE PROBLEMS WERE ENCOUNTERED. THE PROGRAMMING HISTORY OF THE PATIENT'S DEVICE HAS BEEN DOWNLOADED, AND IS BEING SENT TO CYBERONICS, INC. FOR REVIEW TO RECOGNIZE THE CAUSE OF THE PROGRAMMING ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 523493

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR