BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8820022 · Received July 23, 2019

    Report

    Report Number
    6000034-2019-01341
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Report Date
    November 25, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2019, AND THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY. THIS REPORT IS SUBMITTED SEPTEMBER 16, 2019.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED DECEMBER 18, 2019. - ATTACHMENT: [153277 DEVICE ANALYSIS REPORT REG.PDF].

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 24, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND NO SOUND. INTEGRITY TEST RESULTS ARE CONSISTENT WITH A DEVICE MALFUNCTION. THE IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, JULY 24, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608748 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 NI 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention