BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 6134472 · Received November 30, 2016

    Report

    Report Number
    1723170-2016-01255
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    December 30, 2015
    Report Date
    December 21, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE MEDTRONIC REPRESENTATIVE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (B)(6). 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 483 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 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.

    Additional Manufacturer Narrative · 1

    CORRECTION DEVICE UNIQUE DEVICE IDENTIFIER (UDI) NOW PROVIDED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION PROCEDURE, THE DOOR FOR THE IMAGING SYSTEM WOULD NOT OPEN. THE SITE REPRESENTATIVE REPORTED THAT THE SYSTEM WAS AROUND THE PATIENT AT THE TIME. TO TROUBLESHOOT THE ISSUE, THE SYSTEM WAS RESTARTED WITHOUT RESOLUTION. THE SITE PRESSED THE DOOR OVERRIDE BUTTON ALONG WITH THE "M" BUTTON ON THE PENDANT, THIS ALLOWED THE DOOR TO OPEN AND RESOLVED THE ISSUE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE IMAGING SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 10 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786022 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00028-120

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR