BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5830713 · Received July 28, 2016

    Report

    Report Number
    1723170-2016-01604
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    August 19, 2014
    Report Date
    July 28, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE PERFORMING AN IMAGING SYSTEM CHECK-OUT, A MEDTRONIC REPRESENTATIVE DETERMINED THAT THE SOFTWARE WAS CORRUPT AND REQUIRED REINSTALLATION. THE MEDTRONIC REPRESENTATIVE REINSTALLED THE SOFTWARE ON THE IMAGING SYSTEM COMPUTER AND PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. REINSTALLING THE SOFTWARE ON THE COMPUTER RESOLVED THE SYSTEM ISSUE. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) DISTRICT OFFICE ON (B)(6) 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 (B)(6) 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 IMAGE ACQUISITION SYSTEM (IAS) IS NOT CONNECTING TO MOBILE VIEW STATION (MVS). THE IMAGE ACQUISITION SYSTEM (IAS) WILL NOT START UP AND DISPLAYS THAT AN ERROR HAS OCCURRED. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION AND THE IMAGING SYSTEM. THERE WAS A NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482067 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 54 YR