BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CONTOUR ADVANCE

    MDR report key: 6536063 · Received May 2, 2017

    Report

    Report Number
    6000034-2017-00810
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    March 16, 2017
    Report Date
    May 5, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MAY 25, 2017.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MAY 02, 2017.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AFTER SUFFERING AN IMPACT TO THE IMPLANT SITE. THE ELECTRODE ARRAY EXTRUDED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON MARCH 16, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318224 NUCLEUS 24 CONTOUR ADVANCE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24R(CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention