BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1900189 · Received October 22, 2010

    Report

    Report Number
    1723170-2010-00065
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SYSTEM EVAL WILL BE REPORTED UPON COMPLETION.

    Description of Event or Problem · 1

    SITE WAS HAVING PROBLEMS WITH THE SOFTWARE ON THIS SYSTEM RUNNING SLOW, THEN EXITING OUT, WHICH MADE IT DIFFICULT TO NAVIGATE WITH MEDTRONIC NAVIGATION'S FUSION SYSTEM. SITE DID NOT ABORT USE OF THE SYSTEM AND THERE WAS NO IMPACT TO THE PT OUTCOME.

    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