BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 13287336 · Received January 18, 2022

    Report

    Report Number
    6000034-2022-00082
    Event Type
    Injury
    Date Received
    January 18, 2022
    Report Date
    January 3, 2022
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JANUARY 19, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2022 DUE TO AN EXTRUSION OF THE GROUND ELECTRODE INTO THE EXTERNAL AUDITORY CANAL. THE PATIENT HAS NOT BEEN REIMPLANTED WITH A NEW DEVICE AS OF THIS REPORT ON JANUARY 19, 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942020 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 Male Required Intervention