BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3050754 · Received April 10, 2013

    Report

    Report Number
    1723170-2013-00271
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC ENGINEERING CONFIRMED THE FIELD GENERATOR IS NOT FUNCTIONING PROPERLY. WHEN THE CABLE IS CONNECTED TO A TEST SYSTEM THE NAVIGATION TAB SHOWS RED STATUS AND SAYS "AXIEM EMITTER LOW DRIVE ERROR". SOFTWARE DIAGNOSTICS INDICATES AN OPEN ON COIL #5. A NEW EMITTER WAS INSTALLED ON THE FUSION SYSTEM AND RESOLVED THE ISSUE. SYSTEM FULLY FUNCTIONAL AFTER REPLACEMENT OF FIELD GENERATOR (A.K. A. AXIEM EMITTER).

    Description of Event or Problem · 1

    AN OR STAFF MEMBER REPORTED THE FUSION SYSTEM STOPPED NAVIGATING DURING A PROCEDURE. THEY CHECKED TRACKING DETAILS, WHICH SHOWED AN EMITTER COMMUNICATION ERROR. THE SITE DISCONTINUED USE OF NAVIGATION AND PROCEEDED WITH THE SURGERY. NO NEGATIVE IMPACT TO THE PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149635 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 28