BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CONTOUR

    MDR report key: 7340538 · Received March 15, 2018

    Report

    Report Number
    6000034-2018-00616
    Event Type
    Injury
    Date Received
    March 15, 2018
    Report Date
    June 20, 2018
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 15, 2018.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS ELECTIVELY EXPLANTED (DATE NOT REPORTED) DUE TO NON-USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186946 NUCLEUS 24 CONTOUR NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24R (CS) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention