BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5836396 · Received August 1, 2016

    Report

    Report Number
    1723170-2016-01617
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    April 11, 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
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. THE MEDTRONIC REPRESENTATIVE RECEIVED A REPLACEMENT INTERFACE CABLE. AFTER CABLE REPLACEMENT, A MECHANICAL AND FUNCTIONAL TEST WAS PERFORMED ON THE IMAGING SYSTEM. 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 OF THE CABLE. 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 SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE AND PRIOR TO TAKING FLUORO SHOTS, THE IMAGING SYSTEM SWITCHED INTO 'STAND ALONE MODE.' THE SITE REPRESENTATIVE REBOOTED THE SYSTEM. REBOOTING THE SYSTEM DID NOT RESOLVE THE ISSUE. IN TROUBLE-SHOOTING, THE IMAGING SYSTEM THE MEDTRONIC REPRESENTATIVE CHECKED THE SYSTEMS PERFORMANCE AND DETERMINED THE INTERFACE CABLE REQUIRED REPLACEMENT. A REPLACEMENT PART WAS ORDERED. THE SURGEON DISCONTINUED USE OF THE IMAGING SYSTEM 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
    489614 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