BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR BAHA VISTAFIX SYSTEM

    MDR report key: 6013281 · Received October 9, 2016

    Report

    Report Number
    6000034-2016-01946
    Event Type
    Injury
    Date Received
    October 9, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 20, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    FZE
    PMA / PMN Number
    K945154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL IMPLANTATION DETAILS UNAVAILABLE AT THE TIME OF THIS REPORT , THIS REPORT IS FILED ON OCTOBER 10, 2016. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664397 COCHLEAR BAHA VISTAFIX SYSTEM FZE FZE COCHLEAR BONE ANCHORED SOLUTIONS AB BIA200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention