BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5848659 · Received August 4, 2016

    Report

    Report Number
    1723170-2016-01682
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    August 20, 2014
    Report Date
    August 4, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED DUE TO (B)(6) PATIENT PRIVACY REGULATIONS. A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO EXAMINE THE MEDTRONIC IMAGING SYSTEM, REVEALING THE NEED TO EDIT THE IP AND GATEWAY SETTINGS. AFTER THESE NETWORK SETTINGS ADJUSTMENTS, THE SYSTEM PERFORMED AS INTENDED. NO PARTS WERE REPLACED. 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 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 WHILE IN A SPINAL FUSION PROCEDURE, THE MEDTRONIC IMAGING SYSTEM SHOWED ORANGE COMMUNICATION STATUS BETWEEN THE SYSTEM AND MEDTRONIC NAVIGATION SYSTEM ON THE SET UP EQUIPMENT PAGE OF SYNERGY SPINE. HE ATTEMPTED TO REPLUG THE NETWORK CABLE CONNECTION BETWEEN SYSTEMS, RESTART THE SYSTEM AND DIRECTLY CONNECT WITH THE MEDTRONIC NAVIGATION SYSTEM NETWORK PORT WITHOUT RESOLUTION. MEDTRONIC IMAGING WAS ABORTED. CASE CONTINUED WITH A DIFFERENT IMAGING SYSTEM AND MEDTRONIC NAVIGATION SYSTEM. NO DELAY IN SURGERY AND NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498639 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