BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 9966087 · Received April 15, 2020

    Report

    Report Number
    6000034-2020-01046
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 19, 2020
    Report Date
    March 23, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON APRIL 16, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020, IN ORDER TO REPOSITION THE ELECTRODE ARRAY. THE IMPLANTED DEVICE REMAINS INSITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429036 NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) NA 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention