BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 12859144 · Received November 23, 2021

    Report

    Report Number
    6000034-2021-03594
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    April 21, 2021
    Report Date
    November 4, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 23, 2021.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021, TO REPOSITION THE DEVICE DUE TO A MIGRATION OF THE RECEIVER STIMULATOR. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757596 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 82 YR Male Required Intervention