BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2882270 · Received December 20, 2012

    Report

    Report Number
    1723170-2012-00739
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS REPORT IS TO REMOVE A PREVIOUSLY REPORTED CONCLUSION, AS IT WAS NOTICED THAT FOLLOWUP MDR (1723170-2012-00739-1) INCORRECTLY CONTAINED THIS CODE BECAUSE IT DID NOT MATCH THE PREVIOUSLY REPORTED RESULTS OF BOTH THE HARDWARE AND SOFTWARE INVESTIGATIONS THAT FOUND THE ISSUE TO BE RELATED TO COMPUTER HARDWARE, AND THEREFORE UNRELATED TO THE SOFTWARE.

    Additional Manufacturer Narrative · 1

    SUSPECT COMPUTER WAS EVALUATED AND FOUND TO DIRECTLY CAUSE THE ISSUE. PERFORMANCE TESTING RESULTS ARE AS FOLLOWS: CORRUPTED SHARED RESOURCE DATA BASE FILES FOUND. PHD FAILED FULL READ AND INVERSION TEST WHICH SUGGESTS A MALFUNCTIONING HARD DRIVE. A SOFTWARE INVESTIGATION WAS ALSO COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    THE COMPUTER WAS RETURNED AND THE EVALUATION IS CURRENTLY IN PROGRESS. A REPLACEMENT COMPUTER WAS SHIPPED TO THE SITE AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE FUSION ENT BECAME UNRESPONSIVE DURING NAVIGATION. THE MOUSE WAS UNRESPONSIVE SO A HARD SHUTDOWN WAS PERFORMED. THEY WERE ABLE TO PROCEED BACK TO NAVIGATE WITH ABOUT A 5 MINUTE DELAY IN THE PROCEDURE. THE CASE CONTINUED WITHOUT ANYMORE ISSUES WITH THE SOFTWARE. THE REP SAID THE TRACER REGISTRATION TECHNIQUE HAD FAILED TWICE DURING REGISTRATION AND POINTMERGE WAS USED. THE TRACER PATTERN APPEARED TO BE COLLECTING WELL AND THEN DISAPPEARED DURING THE PROCESSING. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR