BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 1883806 · Received October 20, 2010

    Report

    Report Number
    3006556115-2010-00506
    Event Type
    Injury
    Date Received
    October 20, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE ELECTRODE MIGRATED AND THERE IS A CHANGE IN IMPEDANCES. THE PT IS EXPERIENCING SOUND QUALITY ISSUES AND A DECREASE IN PERFORMANCE. REVISION SURGERY WILL BE SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention