BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2802380 · Received October 19, 2012

    Report

    Report Number
    3006556115-2012-00471
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED ELECTRODE MIGRATION, BLEEDING IN THE EAR AND INFECTION. DEVICE TESTING REVEALED NORMAL FUNCTION. THE PT'S DEVICE WAS EXPLANTED. THE PT IS BEING MONITORED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention