BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI512

    MDR report key: 3312642 · Received August 11, 2013

    Report

    Report Number
    3312642
    Event Type
    Malfunction
    Date Received
    August 11, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    COCHLEAR AMERICAS, INC.
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS BEEN USING A COCHLEAR IMPLANT FOR 2 YEARS. SHE HAS A NUCLEUS 512 IMPLANT WHICH HAD A RECALL AND HAD A SUDDEN FAILURE SEVERAL WEEKS AGO. THE CAPSULE OF THE IMPLANT WAS SLIGHTLY OPENED ANTERIORLY AND THE IMPLANT WAS MOBILIZED AND REMOVED FROM THE POCKET. THE POCKET WAS REVISED TO ACCOMMODATE THE NUCLEUS FREEDOM DEVICE AND THE GUTTER WAS DEEPENED TO ALLOW THE THICKER ELECTRODE EXIT FOR THE FREEDOM DEVICE. THE ELECTRODE WAS THEN REMOVED FROM THE COCHLEA. THE COCHLEOSTOMY WAS WIDENED SLIGHTLY WITH A 1 MILLIMETER DIAMOND DRILL. A NUCLEUS FREEDOM COCHLEAR IMPLANT DEVICE, WAS OPENED, TRANSFERRED INTO THE WOUND, AND PLACED IN THE SUBPERIOSTEAL POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385259 NUCLEUS CI512 IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS, INC. C512 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR