BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2973938 · Received February 22, 2013

    Report

    Report Number
    1723170-2013-00110
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC REPRESENTATIVE FOLLOW-UP WITH THE SITE FINDS THE SYSTEMS REPORTED BEHAVIOR HAS NOT BEEN OBSERVED IN CASES PERFORMED SINCE THE ALLEGED MALFUNCTION. SOFTWARE INVESTIGATION HAS NOT BEEN COMPLETED AS OF THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY. THE NAVIGATION SYSTEM AND INSTRUMENTS WERE TESTED ON SITE AND FOUND TO BE FULLY FUNCTIONAL, PASSING ALL ACCURACY TESTING.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT, DURING A TRANSPHENOIDAL PITUITARY SURGERY, THE SURGEON SUSPECTED A 1-2MM INACCURACY WHEN DEEP INSIDE THE SINUSES. A POINTMERGE REGISTRATION WAS USED TO COMPENSATE FOR PATIENT SIZE, EXCESS SKIN, AND CHIN TUCKED IN SCAN VS. PATIENT ACTUAL POSITION IN THE OR. THE GREEN SPHERE ENCOMPASSED THE NOSE, EYES AND COMPLETE SPHENOID SINUS. SURGEON CONTINUED TO USE NAVIGATION FOR THE PROCEDURE. WHEN SURGEON WAS RESECTING THE TUMOR WITH THE BIPOLARS (NON-MEDTRONIC PRODUCT AND NON-NAVIGATED INSTRUMENT) THE CAROTID ARTERY WAS NICKED AND THE PATIENT LOST APPROXIMATELY 3500CC OF BLOOD. THE PATIENT WAS GIVEN 2 UNITS OF BLOOD IN THE ROOM AND TAKEN TO ANGIO/CATH FOR AN EMERGENCY PROCEDURE TO STOP THE BLOOD LOSS. AT THIS POINT, THE SURGERY WAS ON HOLD WITH THE POSSIBILITY THAT THEY WILL BRING THE PATIENT BACK INTO THE ROOM AND COMPLETE THE ORIGINAL TUMOR RESECTION. IN FOLLOW-UP, THE MEDTRONIC REPRESENTATIVE REPORTED THE ORIGINAL BLOOD LOSS WAS NOT CAUSED BY NICKING THE CAROTID, IT WAS A NICK TO THE ANEURYSM. IN THE CATH LAB THEY WERE ABLE TO COIL THE ANEURYSM AND HALT THE BLEEDING WHICH ALLOWED THEM TO PROCEED WITH THE TRANSPHENOIDAL TUMOR RESECTION AND WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78647 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R