BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 3896479 · Received May 16, 2014

    Report

    Report Number
    3006556115-2014-00228
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    ADVANCED BIONICS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED INTERMITTENCIES, NO LOCK WITH THE INTERNAL DEVICE, AND A DEVICE FAILURE. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294720 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR