BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1934422 · Received November 23, 2010

    Report

    Report Number
    1723170-2010-00106
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMITTER WAS RETURNED FOR EVAL. THE EMITTER PASSED PERFORMANCE TESTING AND NAVIGATION SHOWED GREEN STATUS. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY A MEDTRONIC REP. A REPLACEMENT EMITTER WAS SENT TO THE SITE WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A SITE REP REPORTED THEY EXPERIENCED RED STATUS BEHAVIOR DURING AN ENT CASE WITH THE SYSTEM. THE DOCTOR WAS ABLE TO REGISTER THE PATIENT WITH THE SYSTEM, BUT THE SYSTEM DISPLAYED RED STATUS WHEN THEY TRIED TO VERIFY INSTRUMENTS IN THE NAVIGATE TASK OF THE SOFTWARE. MOVING THE EMITTER DID NOT RESOLVE THE ISSUE. THE DOCTOR DECIDED NOT TO USE THE SYSTEM FOR THE PROCEDURE. THERE WAS NO IMPACT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK