BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1930234 · Received November 18, 2010

    Report

    Report Number
    1723170-2010-00083
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A SITE REP REPORTED THAT NAVIGATION FROZE. THE SYSTEM RESUMED TRACKING AND THERE WERE NO FURTHER ISSUES. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK