BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1133034 · Received August 22, 2008

    Report

    Report Number
    1644487-2008-01994
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PHYSICIAN SET PATIENT'S OUTPUT CURRENT TO 3.0MA. PATIENT CAME IN FOR A FOLLOW UP VISIT. WHEN THE DEVICE WAS INTERROGATED, IT SHOWED THE OUTPUT CURRENT WAS SET TO 0MA. THIS MOST LIKELY HAPPENED DUE TO INTERRUPTED DIAGNOSTICS. PATIENT REPORTED HE HAS NOT FELT STIMULATION SINCE HIS LAST OFFICE VISIT AND HAS BEEN FEELING DEPRESSED. THE PHYSICIAN SET THE PATIENT'S OUTPUT CURRENT TO 1.0MA. THE PATIENT REPORTED LATER THAT EVENING THAT HE STILL COULD NOT FEEL THE STIMULATION AGAIN. THIS WAS PROBABLY DUE TO THE PATIENT BEING ACCUSTOMED TO HIGHER SETTINGS. PENDING PROGRAMMING HISTORY FROM SITE.

    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 53 YR