BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 6168593 · Received December 12, 2016

    Report

    Report Number
    6000034-2016-02447
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    October 4, 2016
    Report Date
    November 28, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON DECEMBER 13, 2016, BY COCHLEAR LIMITED ON BEHALF OF (B)(4) EXEMPTION NUMBER E2016011.

    Description of Event or Problem · 0

    PER THE CLINIC THE PATIENT WAS SEDATED IN THE OR ON (B)(6) 2016 IN ORDER TO CONDUCT A NEURAL RESPONSE TEST AND AN INTEGRITY TEST. THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, DECEMBER 13, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817134 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 9 YR Required Intervention