BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 7954956 · Received October 11, 2018

    Report

    Report Number
    6000034-2018-02010
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Report Date
    November 13, 2018
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032643
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON NOVEMBER 15, 2018.

    Description of Event or Problem · 1

    PER THE CLINIC THE DEVICE WAS EXPLANTED ON (B)(6) 2018 DUE TO EXTRUSION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796236 NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE(ST) NA 09321502032643

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention