BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5788598 · Received July 13, 2016

    Report

    Report Number
    6000034-2016-01460
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    June 8, 2016
    Report Date
    September 1, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON JULY 13, 2016. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED SEPTEMBER 13, 2016.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2016 DUE TO NON-USE OF THE DEVICE. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446608 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention