BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 797183 · Received December 20, 2006

    Report

    Report Number
    2029203-2006-00907
    Event Type
    Injury
    Date Received
    December 20, 2006
    Date of Event
    November 30, 2006
    Report Date
    December 20, 2006
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    WHILE WEARING THE EXTERNAL EQUIPMENT, THE PATIENT REPORTEDLY EXPERIENCED PAIN. ON OCTOBER 25, 2006, THE PATIENT WAS SEEN BY A COMPANY REPRESENTATIVE FOR DEVICE EVALUATION. A CT SAN SHOWED THE ELECTRODE HAD MIGRATED OUTSIDE OF THE COCHLEA. TESTING PERFORMED CONFIRMED THE DEVICE WAS FUNCTIONING. A DECISION WAS MADE TO EXPLANT THE DEVICE. SURGERY TO EXPLANT THE PATIENT'S CLL 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-5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention