BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5845287 · Received August 3, 2016

    Report

    Report Number
    1723170-2016-01681
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    July 10, 2014
    Report Date
    August 3, 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

    A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO EXAMINE THE MEDTRONIC IMAGING SYSTEM, RESULTING IN THE DECISION TO SEND LOG FILES TO THE MANUFACTURER FOR ANALYSIS. THE REPRESENTATIVE THEN PERFORMED AN IMAGING SYSTEM CHECK-OUT AND TESTED AREAS PASSED. SYSTEM PERFORMED AS INTENDED. ANALYSIS OF THE LOG FILE AS PART OF THE SOFTWARE INVESTIGATION, THE RING ARTIFACT NO LONGER APPEARED AFTER PERFORMING BOTH RAD AND FLUORO GAIN CALIBRATIONS. PER THE SYSTEM CHECK OUT, THE ISSUE WITH THE SYSTEM STARTING IN STANDALONE (SA) MODE AT STARTUP WAS NO LONGER AN ISSUE AFTER UPGRADING THE SOFTWARE TO VERSION 3.1.6. NO EVIDENCE OF ANY ISSUES FOUND IN LOGS AS WELL RELATED TO IMAGE QUALITY OR STARTING IN STANDALONE MODE. 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 (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 SPINAL FUSION PROCEDURE, THE 3D IMAGES FROM THE MEDTRONIC IMAGING SYSTEM CONTAINED RING ARTIFACT; THE INITIAL 3D SPIN OF PATIENT DID NOT CONTAIN RING ARTIFACT. SURGEON ATTACHED REFERENCE FRAME AND TOOK A 3D SPIN, WHICH CONTAINED THE RING ARTIFACT. THEN HE PROCEEDED TO TAKE ANOTHER 3D SPIN AND THAT IMAGE ALSO CONTAINED ARTIFACT. DUE TO THIS MALFUNCTION, THE SURGEON OPTED TO ABORT MEDTRONIC IMAGING AND NAVIGATION, INSTEAD USING A DIFFERENT IMAGING SYSTEM TO FINISH THE CASE. 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
    496746 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 61 YR