BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5836389 · Received August 1, 2016

    Report

    Report Number
    1723170-2016-01611
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    August 28, 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
    MI, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. WHILE INVESTIGATING THE REPORTED ISSUE, A MEDTRONIC REPRESENTATIVE CONFIRMED THE IMAGE FRAME RATE ERROR. ALSO EVIDENT WAS THAT THE CONNECTION HAD A LOW BANDWIDTH, DISPLAYING TWO GREEN LIGHTS. A REPLACEMENT INTERFACE CABLE WAS SHIPPED TO THE SITE. THE MEDTRONIC REPRESENTATIVE REPLACED THE INTERFACE CABLE AND PERFORMED A MECHANICAL AND FUNCTIONAL TEST OF THE IMAGING SYSTEM. THE TEST REVEALED THAT REPLACING THE INTERFACE CABLE RESOLVED THE ISSUE. AFTER PART REPLACEMENT A MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. THE INTERFACE CABLE WAS RETURNED TO MEDTRONIC FOR ANALYSIS. ON-SITE INVESTIGATION WAS COMPLETED ON THE RETURNED INTERFACE CABLE. A FUNCTIONAL TEST WAS PERFORMED AND FAILED. THE MEDTRONIC INVESTIGATION, FOUND THAT THE CABLE HAD TWO BROKEN WIRES ON THE LEMO END. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO (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 SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S IMAGING SYSTEM DISPLAYED AN 'IMAGE FRAME RATES BELOW EXPECTED LEVELS' MESSAGE WHEN ATTEMPTING TO ACQUIRE FLUORO IMAGES. IN TROUBLE-SHOOTING, THE IMAGING SYSTEM WAS TAKEN INTO ANOTHER ROOM TO TROUBLESHOOT WHERE THE UMBILICAL CABLE WAS RECONNECTED AND SYSTEM REBOOTED. THE ERROR DISPLAY ISSUE PERSISTED. THE SURGEON DISCONTINUED USE OF THE NAVIGATION AND IMAGING SYSTEMS AND CHOSE TO PROCEED WITH A C-ARM, AN ALTERNATE SYSTEM. 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
    488724 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