BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2033612 · Received February 11, 2011

    Report

    Report Number
    1723170-2011-00114
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 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

    PT INFO NOT AVAILABLE AT TIME OF THIS REPORT. MEDTRONIC NAVIGATION, INC., PERFORMED A PEG BOARD TEST AND IT PASSED WITH A MAX ERROR OF 1.309MM. PERFORMED A TRACER REGISTRATION AND IT PASSED, CHECKED POINTS ON THE HEAD MODEL AND THEY ARE WITHIN SPEC. RAN FOR 1 HOUR AND CHECKED THE POINTS AGAIN AND IT HAS NOT CHANGED. RAN OVER THE WEEKEND AND CHECKED THE SAME POINTS AND THERE WAS NO CHANGE. NOT ABLE TO DUPLICATE THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED ALLEGATION OF INACCURACY DURING AN ENT CASE WITH A FUSION DEMO SYSTEM. THERE WAS NO REPORTED REDUCED VOLUME, BUT REPORTED THAT IT SEEMED LIKE THE FIELD "SHIFTED" AS THE CASE WENT ON. THE SURGEON CONTINUED THE CASE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PT OUTCOME. MEDTRONIC NAVIGATION, INC. WAS MADE AWARE OF THIS EVENT ON (B)(6) 2011 VIA A MEDTRONIC ENT REP. CONFIRMATION OF THE DATE OF THE EVENT, THE SURGEON NAME, AND THE PT DEMOGRAPHIC INFO HAVE ALL BEEN REQUESTED.

    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 UNK