BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1841240 · Received September 13, 2010

    Report

    Report Number
    3006556115-2010-00444
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED LOSS OF LOCK WITH HIS INTERNAL DEVICE. EXTERNAL EQUIPMENT HAS BEEN EXCHANGED AND EXTENSIVE PROGRAMMING HAS BEEN PERFORMED. HOWEVER, THIS DID NOT RESOLVE THE ISSUE. SURGERY TO EXPLANT THE PATIENT'S DEVICE HAS BEEN SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR