BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 697597 · Received October 13, 2005

    Report

    Report Number
    2029203-2005-00403
    Event Type
    Malfunction
    Date Received
    October 13, 2005
    Date of Event
    September 19, 2005
    Report Date
    October 13, 2005
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    LOSS OF LOCK WHILE WEARING THE EXTERNAL EQUIPMENT. EXTERNAL EQUIPMENT WAS EXCHANGED. HOWEVER, THE PROBLEM WAS NOT RESOLVED. ON SEPTEMBER 19, 2005, THE PT WAS SEEN BY A COMPANY REP FOR DEVICE EVALUATION. TESTING PERFORMED CONFIRMED THAT THE DEVICE WAS NO LONGER FUNCTIONING. THE PT'S C1 DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR