BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8272974 · Received January 23, 2019

    Report

    Report Number
    6000034-2019-00026
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    October 15, 2018
    Report Date
    April 4, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF DEVICE INDICATES DEVICE FAILURE. THIS REPORT IS FILED ON APRIL 30, 2019. - ATTACHMENT: [133726-DEVICE ANALYSIS REPORT.PDF].

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 24, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT'S DEVICE WAS EXPLANTED DUE TO OPEN CIRCUIT ELECTRODES. THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65619 NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 NA 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention