BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CONTOUR

    MDR report key: 10526282 · Received September 13, 2020

    Report

    Report Number
    6000034-2020-02415
    Event Type
    Malfunction
    Date Received
    September 13, 2020
    Report Date
    October 20, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 9, 2020.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON SEPTEMBER 14, 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS ELECTIVELY EXPLANTED (DATE NOT REPORTED) DUE TO NON-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990769 NUCLEUS 24 CONTOUR NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24R (CS) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention