BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 424028 · Received October 22, 2002

    Report

    Report Number
    2029203-2002-00255
    Event Type
    Malfunction
    Date Received
    October 22, 2002
    Date of Event
    September 23, 2002
    Report Date
    October 22, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY HAS BEEN INCONSISTENT AUDITORY RESPONSES. IN 06/2002, TESTING WAS CONDUCTED. A COMPANY REPRESENTATIVE REVIEWED THE RESULTS AND RECOMMENDED 3 CHANNELS BE TURNED OFF. PROGRAMMING CHANGES WERE ALSO MADE AT THAT TIME. THE PATIENT IMMEDIATELY SHOWED IMPROVED RESPONSIVENESS. IT WAS RECOMMENDED THAT THE CENTER CONTINUE MONITORING THE PATIENT. IN 08/2002, THE PATIENT'S CENTER REPORTED GROWING CONCERNS ABOUT THE PATIENT'S LACK OF PROGRESS. IN 09/2002, THE PATIENT WAS SENT AT THE IMPLANT CENTER FOR DEVICE EVALUATION. ADDITIONAL PROGRAMMING CHANGES WERE MADE. IN 09/2002, THE CLINICIANS, FAMILY AND COMPANY REPRESENTATIVES DECIDED TO SCHEDULED SURGERY. THE DEVICE WILL BE EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR