BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 15733287 · Received November 4, 2022

    Report

    Report Number
    6000034-2022-03223
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    December 15, 2020
    Report Date
    October 11, 2022
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 04, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENTS DURING AN MRI (1.5 TESLA). SURGERY TO REPOSITION THE MAGNET WAS COMPLETED ON DECEMBER 15, 2020. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491938 NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI522 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Required Intervention