BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8401897 · Received March 7, 2019

    Report

    Report Number
    6000034-2019-00329
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 25, 2019
    Report Date
    June 18, 2019
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED ON MAY 24, 2019.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FILED ON JULY 10, 2019. - ATTACHMENT: [142646 DEVICE ANALYSIS REPORT.PDF].

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192908 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 N/A 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention