BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 19890671 · Received August 2, 2024

    Report

    Report Number
    6000034-2024-02728
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 6, 2024
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON JULY 09, 2024 AND THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT. THE PATIENT ALSO UNDERWENT SKIN REVISION SURGERY ON (B)(6) 2024 FOR A ROTATIONAL SCALP FLAP PROCEDURE.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED AN EXTRUSION OF THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240168 NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention