BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3884949 · Received June 19, 2014

    Report

    Report Number
    1723170-2014-00663
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMOUNT OF ALLEGED INACCURACY WAS 1-2 MM. THE DELAY REQUIRED TO REPAIR THE CSF LEAK WAS 30-45 MINUTES. THE PATIENT WAS SEEN A WEEK LATER WITH NO PROBLEMS OR CONCERNS AND IS DOING WELL.

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED TO PROVIDE PATIENT WEIGHT, REFERENCING (B)(6) PRIVACY LAWS. ON (B)(4) 2014, A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. SYSTEM HAS BEEN USED IN SUBSEQUENT PROCEDURES WITH NO REPORTED ISSUES. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON WAS INACCURATE IN THE ETHMOID SINUS AND A CEREBROSPINAL FLUID LEAK (CSF) OCCURRED. THE LEAK WAS IMMEDIATELY REPAIRED INTRA-OP AND THERE WERE NO FURTHER PATIENT COMPLICATIONS. THE SURGEON REPORTED BEING ACCURATE NEAR THE EYE AND IN ALL OTHER SINUSES. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE NAVIGATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359604 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention