BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARION IMPLANT

    MDR report key: 3954847 · Received July 17, 2014

    Report

    Report Number
    3006556115-2014-00350
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT ELECTED TO UNDERGO REVISION SURGERY FOR A TECHNOLOGY UPGRADE. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419303 CARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention