BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5847188 · Received August 4, 2016

    Report

    Report Number
    1723170-2016-01540
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    June 17, 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
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM AND EVALUATION: ON (B)(6) 2014, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT AND FOUND AN IMAGING FAILURE, "INTERMITTENT EARLY TERMINATION OF 3D SPIN.¿ THE MOBILE VIEW STATION (MVS) COMPUTER, CP1 AND PLEORA COMPONENTS WERE REPLACED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE FOLLOWING PART WAS RETURNED TO THE MANUFACTURER WITH FUNCTIONAL PROBLEMS THAT DIRECTLY CAUSED THE REPORTED EVENT: THE CP1 PROCESSOR WAS RETURNED FOR ANALYSIS AND AN ELECTRICAL FAILURE MODE WAS FOUND. THE REPORTED PROBLEM "INTERMITTENT EARLY TERMINATION OF 3D SPIN" WAS CONFIRMED. THE CP1 WAS INSTALLED ON A SIMILAR IMAGING SYSTEM AND, DURING 3D SPIN RECEIVED "ERROR RECONSTRUCTING THE IMAGE.¿ THIS ERROR WAS INTERMITTENT. WHEN THE CP1 WAS CHANGED WITH A KNOWN GOOD CP, THE 3D SPIN WORKED AS EXPECTED. THE FOLLOWING PARTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, THESE PARTS DID NOT CAUSE THE REPORTED EVENT AND/OR NO FUNCTIONAL PROBLEM WAS FOUND: THE PLEORA IPORT WAS RETURNED FOR ANALYSIS. THE PLEORA BOX WAS INSTALLED ON A SIMILAR IMAGING SYSTEM AND WORKED WITHOUT ANY ISSUES; NO FAULT FOUND. THE REPORTED PROBLEM "INTERMITTENT EARLY TERMINATION OF 3D SPIN¿ WAS DUE TO A DEFECTIVE CP1 THAT WAS RETURNED ALONG WITH THIS PART. THE MOBILE VIEW STATION (MVS) COMPUTER WAS RETURNED FOR ANALYSIS. THE MVS COMPUTER WAS INSTALLED ON A SIMILAR IMAGING SYSTEM AND WORKED WITHOUT ANY ISSUES; NO FAULT FOUND. THE REPORTED PROBLEM "INTERMITTENT EARLY TERMINATION OF 3D SPIN¿ WAS DUE TO A DEFECTIVE CP1 THAT WAS RETURNED ALONG WITH THIS PART. 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.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE, WHILE CONFIRMING PLACEMENT OF A SCREW, THE RADIOLOGIC TECHNOLOGIST (RT) TRIED TAKING TWO SPINS BUT EACH ONE WAS INTERRUPTED AND INCOMPLETE, STOPPING A QUARTER OF THE WAY THROUGH EACH SPIN. IN TROUBLE-SHOOTING, RE-BOOTING THE IMAGING SYSTEM AND THEN USING THE HAND SWITCH TO TAKE ANOTHER SPIN DID NOT RESOLVE THE ISSUE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. A C-ARM WAS USED TO CONFIRM SCREW PLACEMENT. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499221 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 71 YR