BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 10577871 · Received September 23, 2020

    Report

    Report Number
    6000034-2020-02547
    Event Type
    Injury
    Date Received
    September 23, 2020
    Report Date
    November 24, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ANALYSIS REPORT IS ATTACHED. THIS REPORT IS SUBMITTED ON DECEMBER 14, 2020.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON 24 SEPTEMBER 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO LIMITED BENEFIT AND NON-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042556 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 NA 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention