BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2152476 · Received June 28, 2011

    Report

    Report Number
    1723170-2011-01160
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO AS NO PT WAS PRESENT IN THIS CONCERN. MEDTRONIC REP DOWNGRADED SOFTWARE AND REALIZED THERE WERE LOTS OF PT EXAMS ON SYSTEM, ONCE ERASING THE EXAMS, THE SYSTEM PERFORMED AS INTENDED. RMA ISSUED FOR REPLACEMENT COMPUTER.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED, THE FUSION NAVIGATION SYSTEM IS RESPONDING SLOWLY EVEN THOUGH ALL OF THE PT ARCHIVE FILES HAVE BEEN REMOVED. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1