BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1447351 · Received August 24, 2009

    Report

    Report Number
    6000034-2009-00595
    Event Type
    Malfunction
    Date Received
    August 24, 2009
    Date of Event
    July 27, 2009
    Report Date
    July 27, 2009
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS KICKED IN THE HEAD AT THE SITE OF THE IMPLANT AFTER WHICH HE WAS UNABLE TO GET BENEFIT FROM THE DEVICE. EXPLANT AND REIMPLANTATION IS PLANNED, BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT AUGUST 24, 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention