BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 7360795 · Received March 21, 2018

    Report

    Report Number
    6000034-2018-00644
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Report Date
    November 21, 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
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2019, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY. THIS REPORT IS SUBMITTED DECEMBER 19, 2019.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON MARCH 22, 2018.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON MARCH 22, 2018 WAS FILED INADVERTENTLY, NO EXPLANT HAS OCCURRED AND THE IMPLANTED DEVICE REMAINS IN SITU.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE. SUBSEQUENTLY THE DEVICE WAS EXPLANTED (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199437 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 N/A 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention