BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 12873192 · Received November 25, 2021

    Report

    Report Number
    6000034-2021-03576
    Event Type
    Injury
    Date Received
    November 25, 2021
    Report Date
    November 4, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502009317
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 25, 2021.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT UNDERWENT A MAGNET REPLACEMENT SURGERY ON (B)(6) 2021 DUE TO A MAGNET DISLODGEMENT. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772039 NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (ST) NA 09321502009317

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention