BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 6179906 · Received December 15, 2016

    Report

    Report Number
    6000034-2016-02443
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    November 23, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON DECEMBER 16, 2016, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE IMPLANT, RE-IMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT DECEMBER 16, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829029 NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) N/A 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention