BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 12858570 · Received November 22, 2021

    Report

    Report Number
    6000034-2021-03564
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 29, 2019
    Report Date
    November 2, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502036818
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 23, 2021.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2019 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750976 NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI612 NA 09321502036818

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Male Required Intervention