BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5836423 · Received August 1, 2016

    Report

    Report Number
    1723170-2016-01626
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    October 30, 2014
    Report Date
    August 1, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. WHILE INVESTIGATING THE REPORTED ISSUE, A MEDTRONIC REPRESENTATIVE CONFIRMED THAT THE ROTOR ABRUPTLY STOPS DURING ROTATION ALONG MULTIPLE POINTS IN TRAVEL. THIS HAPPENED DURING 3D MODE AND WHILE USING THE PENDANT CONTROLS. A REPLACEMENT GANTRY MOTION CONTROL BOX WAS SHIPPED TO THE SITE. THE MEDTRONIC REPRESENTATIVE REPLACED THE BOX AND PERFORMED A MECHANICAL AND FUNCTIONAL TEST OF THE IMAGING SYSTEM. THE TEST REVEALED THAT REPLACING THE GANTRY MOTION CONTROL BOX RESOLVED THE ISSUE. AFTER PART REPLACEMENT A MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. THE GANTRY MOTION CONTROL BOX WAS RETURNED TO MEDTRONIC FOR ANALYSIS. ON-SITE INVESTIGATION WAS COMPLETED ON THE RETURNED GANTRY MOTION CONTROL BOX. THE MEDTRONIC INVESTIGATION, CONFIRMED THE REPORTED PROBLEM "ROTOR WILL COME TO ABRUPT STOP AT DIFFERENT SPOTS. THIS OCCURS DURING 3D SPIN". DETERMINATION WAS THAT THE MOTION CONTROL BOX WAS DEFECTIVE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (B)(4). THIS REVIEW WAS PERFORMED AS A RESULT OF RECENT CHANGES/IMPROVEMENTS TO THE MEDTRONIC NAVIGATION, INC. MEDICAL DEVICE REPORT (MDR) REVIEW PROCESS AND IS FOR NON-ADVERSE EVENT REPORTABLE MALFUNCTIONS WITHIN THE LAST TWO YEARS WHERE THE USE OF THE O-ARM IMAGING SYSTEM WAS ABORTED. THIS PROCESS CHANGE RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY MEDTRONIC NAVIGATION, INC., SINCE APRIL 2016. IT SHOULD BE NOTED THAT THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE REGULATIONS WITHIN OUR PROCESSES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE PROCEDURE, THE SITE'S IMAGING SYSTEM WAS UNABLE TO TAKE A 3D SPIN. WHILE ATTEMPTING TO ACQUIRE A SPIN THE IMAGING SYSTEM ROTARY ABRUPTLY STOPPED DURING THE SPIN. THE SURGEON DISCONTINUED USE OF THE IMAGING SYSTEM AND OPTED TO PROCEED WITH A C-ARM, AN ALTERNATE SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489858 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1