BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3090720 · Received May 2, 2013

    Report

    Report Number
    1723170-2013-00309
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WAS ONSITE TO OBSERVE THE CASE. SHE REPORTED THAT THE SURGEON REPOSITIONED THE PATIENT DURING SURGERY AND MAY HAVE SLIGHTLY MOVED THE PATIENT REFERENCE. THIS IS THE MOST LIKELY CAUSE OF THE REPORTED EVENT AS THE SITE WAS ABLE TO RE-REGISTER TO RESTORE ACCURACY, AND HAS HAD NO FURTHER ISSUES WITH INACCURACY.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING NAVIGATION, THE SYSTEM WAS ABOUT 1 CM INACCURATE LATERALLY. WHEN THE SURGEON TOUCHED THE TIP OF THE NOSE, IT SHOWED HIM IN SPACE TO THE SIDE. THE REP SAID THEY WERE ACCURATE AFTER REGISTERING AND FOR THE FIRST 45 MINUTES OF NAVIGATION. AFTER 45 MINUTES THE SYSTEM BECAME INACCURATE. THEY TRIED DIFFERENT INSTRUMENTS AND RE-VERIFYING THE PROBE, SYSTEM WAS STILL INACCURATE. THE SURGEON REREGISTERED AND ACCURACY WAS RESTORED. NO FURTHER ISSUES WERE OBSERVED. THE REP REPORTED THE SURGEON DID REPOSITION THE PATIENT DURING SURGERY AND MAY HAVE SLIGHTLY MOVED THE PATIENT REFERENCE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192243 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR