BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CONTOUR

    MDR report key: 6313040 · Received February 8, 2017

    Report

    Report Number
    6000034-2017-00344
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Date of Event
    January 30, 2017
    Report Date
    January 30, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502002349
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON FEBRUARY 09, 2017.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. 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, FEBRUARY 09, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94488 NUCLEUS 24 CONTOUR NUCLEUS 22 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24R (CS) N/A 09321502002349

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention