BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2870727 · Received December 12, 2012

    Report

    Report Number
    6000034-2012-02352
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    December 5, 2012
    Report Date
    September 20, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED DECEMBER 3, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPONENT: IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT HAS PERMANENTLY DISCONTINUED USE OF DEVICE DUE TO REPORTS OF HEADACHES AND DISCOMFORT. THERE ARE PLANS TO EXPLANT THE DEVICE AND REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, IT HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4) 2013. THIS REPORT IS FILED (B)(4) 2013. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED ABNORMAL SOUND QUALITY AND INTERMITTENCIES WITH DEVICE USE. THERE ARE NO PLANS TO EXPLANT THE DEVICE/REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(4) 2012. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention