BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 7258524 · Received February 9, 2018

    Report

    Report Number
    6000034-2018-00346
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    January 17, 2018
    Report Date
    February 1, 2018
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON FEBRUARY 09, 2018, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED MAGNET RETENTION ISSUES. SUBSEQUENTLY, THE PATIENT UNDERWENT SKIN FLAP REVISION SURGERY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103656 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 74 YR Required Intervention