BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 11565938 · Received March 24, 2021

    Report

    Report Number
    6000034-2021-00918
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 23, 2021
    Report Date
    February 23, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502036818
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 25, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021, DUE TO IMPROPER PLACEMENT OF THE ELECTRODE ARRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459431 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 66 YR Required Intervention