BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 6049691 · Received October 24, 2016

    Report

    Report Number
    6000034-2016-02124
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    October 10, 2016
    Report Date
    December 21, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, IT WAS REPORTED THAT DEVICE WAS EXPLANTED ON (B)(6) 2016 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON OCTOBER 24, 2016. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. 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, OCTOBER 24, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702256 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI512 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention