BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5833477 · Received July 29, 2016

    Report

    Report Number
    1723170-2016-01786
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    September 12, 2014
    Report Date
    July 29, 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 WENT TO THE SITE TO TEST THE EQUIPMENT. THE MEDTRONIC REPRESENTATIVE PERFORMED AN ANALOG OFFSET, FLUORO, AND RAD GAIN CALS WHICH WAS REPORTED TO HAVE RESOLVED THE ISSUE. THE MEDTRONIC REPRESENTATIVE REPORTED THE SYSTEM IS FULLY FUNCTIONAL AND WAS USED IN A CASE WITHOUT AN ISSUE. 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 3/17/2016 FDA-483 FEI: (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 DURING A SPINAL FUSION PROCEDURE THE IMAGE FROM THE IMAGING SYSTEM HAD A "BULLS EYE EFFECT". THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THERE WAS 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
    485942 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 75 YR