BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 725826 · Received June 5, 2006

    Report

    Report Number
    2029203-2006-00374
    Event Type
    Malfunction
    Date Received
    June 5, 2006
    Date of Event
    May 29, 2006
    Report Date
    June 5, 2006
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON MAY 25, 2006, THE PATIENT REPORTEDLY HIT HER HEAD WHILE AT THE SWIMMING POOL. ON MAY 29, 2006 WHILE WEARING THE EXTERNAL EQUIPMENT, THE PATIENT REPORTEDLY HAD NO SOUND PERCEPTION. THE PATIENT WAS SEEN AT CENTER FOR DEVICE EVALUATION. TESTING PERFORMED CONFIRMED THAT THE DEVICE WAS NO LONGER FUNCTIONING. SURGERY TO EXPLANT THE PATIENT'S C1 DEVICE IS TO BE SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR