BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1021395 · Received March 24, 2008

    Report

    Report Number
    3006556115-2008-00159
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    March 3, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELL SEVERAL TIMES AND WAS KICKED IN THE HEAD. THE PT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES AND A DECREASE IN PERFORMANCE. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THE PROBLEM WAS NOT RESOLVED. TESTING CONFIRMED THAT THE DEVICE WAS NOT FUNCTIONING. IT WAS REPORTED THAT THE PT HAS SOME ELECTRODES THAT WERE EXTRA-COCHLEAR FROM THE IMPLANT SURGERY. THE PT'S FAMILY DECIDED TO MOVE FORWARD FOR RE-IMPLANTATION IN ORDER TO ATTEMPT BETTER ELECTRODE ARRAY PLACEMENT AND PERFORMANCE. SURGERY TO EXPLANT THE PT'S DEVICE AND RE-IMPLANT WITH ANOTHER ADVANCED BIONICS DEVICE IS SCHEDULED.

    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