BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6100363 · Received November 14, 2016

    Report

    Report Number
    1723170-2016-03413
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    May 29, 2015
    Report Date
    November 14, 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 WEIGHT WAS NOT PROVIDED. AFTER CALIBRATION, ALL ISSUES WITH THE IMAGING SYSTEM'S IMAGES WERE CORRECTED. THERE WERE NO BLUE LINES IN THE IMAGING SYSTEM'S IMAGES FOR THE FOLLOWING CASE. SYSTEM FULLY FUNCTIONAL. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS UNRELATED TO A SOFTWARE ISSUE. THE SOFTWARE FUNCTIONED AS DESIGNED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. 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 REPORTED MALFUNCTION WAS NOT PREVIOUSLY ASSOCIATED WITH SERIOUS INJURIES. SIMILAR MALFUNCTIONS THAT HAD RESULTED IN SIGNIFICANT DELAYS OF SURGERY OR REQUIRED ADDITIONAL INTERVENTION HAD BEEN REPORTED AS MDR SERIOUS INJURIES. BASED ON THIS 483 OBSERVATION, THE REPORTING DETERMINATION HAS BEEN REVISED TO CONSIDER THESE MALFUNCTION EVENTS REPORTABLE. 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 SITE WAS RECEIVING BLUE LINES AROUND THE BONY ANATOMY ON THE 2D AND 3D IMAGES OF THE IMAGING SYSTEM. SURGEON PROCEEDED TO USE THE IMAGES FOR THE NON-NAVIGATED ORTHO SURGERY WITH NO DELAY TO THE PROCEDURE. THE RADIOLOGIC TECHNOLOGIST (RT) OPERATING THE OPERATING THE IMAGING SYSTEM NOTICED THAT THE RAD AND FLUORO CALIBRATIONS WERE OVERDUE. THE MEDTRONIC REPRESENTATIVE SUGGESTED THE SITE PERFORM CALIBRATIONS AND THEN TAKE ANOTHER IMAGE AFTER THE SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752149 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 13 YR