BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 429177 · Received November 22, 2002

    Report

    Report Number
    2029203-2002-00289
    Event Type
    Injury
    Date Received
    November 22, 2002
    Date of Event
    October 15, 2002
    Report Date
    November 22, 2002
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IN JUNE 2002, THE PATIENT WAS SEEN AT THE IMPLANT CENTER FOR DEVICE EVALUATION. PATIENT REPORTED POOR PROGRESS AND PERCEPT PROBLEMS. TESTING PERFORMED INDICATED THAT THERE WERE OUT OF NORMAL RANGE IMPEDANCE VALUES ON TWO CHANNELS. A COMPANY REPRESENTATIVE REVIEWED THESE FINDINGS AND RECOMMENDED THAT AN X-RAY AND CT SCAN BE PERFORMED TO VERIFY THE POSITION OF THE ARRAY IN THE COCHLEA. IN JULY 2002, THE SURGEON REVIEWED THE X-RAY AND INDICATED THAT 4 ELECTRODES WERE OUTSIDE THE COCHLEA. A COMPANY REPRESENTATIVE RECOMMENDED THAT PROGRAMMING ADJUSTMENTS BE MADE. ON OCTOBER 24, 2002, THE CENTER NOTIFIED THE COMPANY THAT THE DEVICE WAS EXPLANTED IN 2002. A CT SCAN REVEALED A MIGRATING ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP. AB-5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention