BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5655717 · Received May 16, 2016

    Report

    Report Number
    6000034-2016-00991
    Event Type
    Injury
    Date Received
    May 16, 2016
    Report Date
    April 28, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON MAY 16, 2016. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED (DATE NOT REPORTED), DUE TO AN UNKNOWN REASON. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, MAY 16, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312332 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI 11+11+2M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention