BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1083063 · Received March 11, 2008

    Report

    Report Number
    3006556115-2008-00130
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED DETERIORATION IN SOUND QUALITY. IN ADDITION, THE PATIENT REPORTED THAT HE COULD FEEL THE IMPLANT PROTRUDING UNDER HIS SKIN. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE HOWEVER, THE PROBLEM WAS NOT RESOLVED. THE PATIENT UNDERWENT A REVISION SURGERY IN 2008, TO EXPLANT THE DEVICE AND WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1