BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1030620 · Received April 16, 2008

    Report

    Report Number
    3006556115-2008-00183
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES WITH HIS DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE. HOWEVER, THE PROBLEMS WERE NOT RESOLVED. TESTING CONFIRMED THAT THE DEVICE WAS FUNCTIONING. THE PT'S FAMILY DECIDED TO MOVE FORWARD TO EXPLANT THE PT'S IMPLANT AND REIMPLANT WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1