BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3914731 · Received July 4, 2014

    Report

    Report Number
    6000034-2014-01005
    Event Type
    Malfunction
    Date Received
    July 4, 2014
    Date of Event
    June 9, 2014
    Report Date
    March 20, 2017
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COCHLEAR IMPLANT WAS RE-EVALUATED ON MARCH 14, 2016, USING THE INTEGRITY TEST SYSTEM. THE RESULTS ARE CONSISTENT WITH A DEVICE MALFUNCTION. THE IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED MAY 9, 2016. IMPLANTED DEVICE REMAINS INSITU.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2016 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED ON DECEMBER 12, 2016.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON APRIL 13, 2017.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT RESULTING IN LOSS OF CLINICAL BENEFIT. 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, (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392589 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI22M

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention