BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION IMPLANT

    MDR report key: 3030350 · Received March 28, 2013

    Report

    Report Number
    3006556115-2013-00100
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 22, 2008
    Report Date
    February 26, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT REPORTEDLY HAD NO SOUND AND THE ELECTRODES OF THE DEVICE WERE OPEN. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129697 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100H-11A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention