BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8472068 · Received April 1, 2019

    Report

    Report Number
    6000034-2019-00482
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    March 14, 2019
    Report Date
    September 4, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL: IT HAS SINCE BEEN 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 SUBMITTED ON JUNE 12, 2019.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED SEPTEMBER 12, 2019. - ATTACHMENT: [144812 DEVICE ANALYSIS REPORT.PDF].

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON APRIL 02, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, 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 A NEW DEVICE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263381 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 8 YR Required Intervention