BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 8388794 · Received March 4, 2019

    Report

    Report Number
    6000034-2019-00294
    Event Type
    Injury
    Date Received
    March 4, 2019
    Report Date
    February 19, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032599
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 05, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENT FOLLOWING AN MRI (TESLA UNKNOWN). THE PATIENT'S HEAD WAS WRAPPED AS AN APPROVED INDICATION IN EUROPE. SURGERY TO REPOSITION THE MAGNET HAS BEEN COMPLETED (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180236 NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI522 N/A 09321502032599

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention