BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 726073 · Received June 8, 2006

    Report

    Report Number
    2029203-2006-00358
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    May 25, 2006
    Report Date
    June 8, 2006
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED AN UNCOMFORTABLE SENSATION AT IMPLANT SITE FOLLOWED BY NO LOOK BETWEEN THE EXTERNAL EQUIPMENT AND THE COCHLEAR IMPLANT. THE PATIENT WAS SEEN AT CENTER FOR DEVICE EVALUATION. EXTERNAL EQUIPMENT WAS EXCHANGED. HOWEVER, THE REPORTED PROBLEM WAS NOT RESOLVED. ON MAY 25, 2006 THE PATIENT WAS SEEN BY A COMPANY REPRESENTATIVE FOR DEVICE EVALUATION. TESTING CONFIRMED THAT THE DEVICE WAS NOT 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 46 YR