BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2193365 · Received July 29, 2011

    Report

    Report Number
    3006556115-2011-00374
    Event Type
    Injury
    Date Received
    July 29, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS REPORTEDLY EXPERIENCED A DECLINE IN PERFORMANCE. THE PATIENT REPORTS SOUND QUALITY ISSUES. EXTERNAL EQUIPMENT WAS EXCHANGED. TESTING HAS SHOWN THAT THE PATIENT'S DEVICE IS FUNCTIONING. AT THE INSISTENCE OF THE PATIENT'S FAMILY, THE CENTER WILL PURSUE DEVICE REVISION SURGERY.

    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 Required Intervention