BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 19727950 · Received July 12, 2024

    Report

    Report Number
    6000034-2024-02511
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 14, 2024
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024, DUE TO AN INFECTION (NON-DEVICE RELATED). IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341366 NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE(CA) NA 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Required Intervention