BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 5833740 · Received July 29, 2016

    Report

    Report Number
    1723170-2016-01849
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    April 24, 2015
    Report Date
    July 29, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ALL DIGITS, SHOULD READ: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE MOTION CHARGER BOARD WAS NOT CHARGING BATTERIES. THE REP REPLACED THE MOTOR CHARGER BOARD AND BATTERIES AND PERFORMED A SYSTEM CHECKOUT. THE REP TESTED THE NEW BATTERIES AND THEY WERE HOLDING A CHARGE. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL ISSUE WITH THE RETURNED MOTOR CHARGER BOARD. THE D9D COMPONENT WAS DAMAGED DUE TO ELECTRICAL OVERSTRESS. THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION SURGERY AFTER TAKING AP AND LATERAL SHOTS THE PENDANT STATED BATTERY LEVEL WAS CRITICAL ON THE IMAGING SYSTEM. THE REP NOTED THAT THE SYSTEM IS STORED PLUGGED IN AND CHARGING. THEY DID NOT PROCEED TO TAKE THE 3D SPIN. SURGEON DISCONTINUED THE USE OF THE IMAGING SYSTEM. THE CASE WAS CONTINUED USING A C-ARM WITHOUT NAVIGATION. THERE WAS NO REPORTED IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486049 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00028-120

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR