BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 15947411 · Received December 8, 2022

    Report

    Report Number
    6000034-2022-03692
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    November 3, 2022
    Report Date
    November 17, 2022
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502036818
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON DECEMBER 09, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2022 FOR UNSPECIFIC MEDICAL REASONS. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571673 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 63 YR Male Required Intervention