BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2884704 · Received December 24, 2012

    Report

    Report Number
    6000034-2012-02428
    Event Type
    Malfunction
    Date Received
    December 24, 2012
    Date of Event
    December 16, 2012
    Report Date
    June 12, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED JUNE 17, 2014.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED HEADACHES AND SHOCKING SENSATION WITH STIMULATION, AND THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(6), 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24R (CS)

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention