BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 13706414 · Received March 9, 2022

    Report

    Report Number
    6000034-2022-00619
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Report Date
    February 14, 2022
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON MARCH 09, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENTS DURING AN MRI. SURGERY TO REPAIR THE MAGNET POCKET WAS COMPLETED ON (B)(6) 2022. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490697 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 Male Other