BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6064695 · Received October 28, 2016

    Report

    Report Number
    1723170-2016-03224
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 26, 2014
    Report Date
    October 28, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE'S NEURO COORDINATOR REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE IMAGES TAKEN BY THE IMAGING SYSTEM WOULD NOT TRANSFER OVER TO THE NAVIGATION SYSTEM. SITE TRIED TO SWAP NETWORK CABLE AND REBOOT THE SYSTEM BUT THIS DID NOT RESOLVE THE ISSUE. DELAY TO THE PROCEDURE WAS LESS THAN 1 HOUR WITH NO IMPACT OVER PATIENT OUTCOME. FURTHER INVESTIGATIONS OF THE ISSUE DISCOVERED THAT A USE ERROR OCCURRED AS THERE WERE SEVERAL MOTION ERRORS THAT REGISTERED IN THE SYSTEM LOGS WHILE ATTEMPTING A NAVIGATED 3D SCAN. HIS RESULTED IN THE NAVIGATION SCAN BEING CANCELLED AND THE SOFTWARE PREVENTED IT FROM TRANSFERRING THE S7. THIS IS USUALLY CAUSED WHEN THERE IS SUDDEN MOTION THE DURING THE 3D SCAN FROM EITHER THE CAMERA, SPINE FRAME OR TOO MUCH PATIENT MOVEMENT. NO PART RETURN / REPLACEMENT WILL BE NECESSARY. NO FURTHER ISSUES REPORTED. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. (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 REPORTED MALFUNCTION WAS NOT PREVIOUSLY ASSOCIATED WITH SERIOUS INJURIES. SIMILAR MALFUNCTIONS THAT HAD RESULTED IN SIGNIFICANT DELAYS OF SURGERY OR REQUIRED ADDITIONAL INTERVENTION HAD BEEN REPORTED AS MDR SERIOUS INJURIES. BASED ON THIS (B)(4) OBSERVATION, THE REPORTING DETERMINATION HAS BEEN REVISED TO CONSIDER THESE MALFUNCTION EVENTS REPORTABLE. 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

    THE SITE'S NEURO COORDINATOR REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE IMAGES TAKEN BY THE IMAGING SYSTEM WOULD NOT TRANSFER OVER TO THE NAVIGATION SYSTEM. SITE TRIED TO SWAP NETWORK CABLE AND REBOOT THE SYSTEM BUT THIS DID NOT RESOLVE THE ISSUE. DELAY TO THE PROCEDURE WAS LESS THAN 1 HOUR WITH NO IMPACT OVER PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715163 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