BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1912245 · Received November 18, 2010

    Report

    Report Number
    3006556115-2010-00575
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. SURGERY TO EXPLANT THE PATIENT'S DEVICE WILL BE SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR