BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3931026 · Received July 14, 2014

    Report

    Report Number
    6000034-2014-00942
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    September 30, 2015
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2014, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED JUNE 13, 2015. DEVICE NOT YET RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT EXPLANTATION DATE IS (B)(6) 2014, AS PREVIOUSLY REPORTED. THE REPORT IS FILED OCTOBER 9, 2015.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE AND EXTRUSION OF THE ELECTRODE ARRAY INTO THE OUTER EAR CANAL. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410412 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RST

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention