BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 3950570 · Received July 22, 2014

    Report

    Report Number
    1723170-2014-00792
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    February 17, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM (B)(6) 2015 TO (B)(6) 2016. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON (B)(6) 2016. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS DISCOVERED ON 27-JAN-2016, THAT AN INCORRECT DATE WAS REFERENCED IN A PREVIOUS SUPPLEMENTAL 3500A SUBMISSION. THE REPORTED DATE OF 16-AUG-2016 WAS REPORTED INCORRECTLY AND SHOULD BE 16-AUG-2015.STATEMENT IN PREVIOUS SUPPLEMENTAL 3500A SUBMISSION SHOULD READ: ¿ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2015. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2015. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.¿

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED TO PROVIDE PATIENT IDENTIFIER, AGE AND WEIGHT, REFERENCING (B)(4)'S PRIVACY LAWS. A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THAT AT THE TIME THE SURGEON DECIDED TO HALT THE PROCEDURE, THE PATIENT WAS UNDER ANESTHESIA AND AN INCISION HAS BEEN MADE. THE PROCEDURE WAS DELAYED 24 HOURS AND THERE WAS NO IMPACT TO PATIENT REPORTED. THE SITE REPORTED TO A ANOTHER MEDTRONIC REPRESENTATIVE THAT WHEN THE O-ARM 1000 IMAGING SYSTEM WAS BOOTED-UP, THE ISSUE WAS FOUND TO BE RESOLVED. NO DETAILS WERE PROVIDED. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE NAVIGATION SOFTWARE INVESTIGATION FOUND THAT THE CONNECTION BETWEEN THE MOBILE VIEW STATION (MVS) AND IMAGE ACQUISITION SYSTEM (IAS) COMPUTERS WAS INITIALLY ACTIVE AND THEN BECAME INACTIVE THUS PREVENTING THE MVS APPLICATION FROM RETRIEVING THE GAIN CALIBRATION FILE FROM THE IAS SYSTEM. THE CONNECTION BEING DROPPED COULD POSSIBLY BE ATTRIBUTED TO AN INTERMITTENT CONNECTION OR DUE TO A TIMING ISSUE. THE NAVIGATION APPLICATION FUNCTIONED AS DESIGNED, AND AS PREVIOUSLY REPORTED THE SOFTWARE ISSUE WAS DOCUMENTED ON THE IMAGING SYSTEM SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    TYPE OF EVENT CORRECTED.

    Additional Manufacturer Narrative · 1

    FURTHER ENGINEERING RETROSPECTIVE REVIEW FOUND TWO SIMILAR COMPLAINTS WITH A SAFETY RISK MANAGEMENT ASSESSMENT OF "NEGLIGIBLE" HARM. SINCE THERE WAS NO ADDITIONAL RE-OCCURRENCE OF THE ISSUE ON THIS PARTICULAR SYSTEM, THE DECISION WAS MADE THAT NO FURTHER ACTIONS WERE WARRANTED. THE REPORTED ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE. NO FURTHER SUBSEQUENT ISSUES HAVE BEEN REPORTED WITH THIS SYSTEM.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE USING A NAVIGATION SYSTEM AND AN IMAGING SYSTEM. TO TAKE IMAGES USING THE O-ARM 1000 IMAGING SYSTEM, THE OPERATOR ACCESSED THE O-ARM PROTOCOL IN NAVIGATION SYSTEM FOR SET-UP. ON THE NAVIGATION SYSTEM SCREEN, BOTH SYSTEMS WERE NOT SHOWN WITH GREEN LINES INDICATING THEY WERE NOT CONNECTED TO EACH OTHER. IN TROUBLE-SHOOTING, BOTH SYSTEMS WERE RE-STARTED AND THE LAN CABLE WAS REPLACED, HOWEVER, ISSUE WAS NOT RESOLVED. O-ARM DATA COULD NOT BE SHOWN ON MOBILE VIEWING SYSTEM (MVS) AND THE COMMUNICATION HAD BEEN LOST. AT START-UP, THE SYSTEM SCREEN DID NOT SHOW THE EXPECTED WARNING MESSAGE NOTING THE NUMBER OF DAY(S) PASSED SINCE THE LAST CALIBRATION. THE SURGEON OPTED TO DISCONTINUE USE OF THE NAVIGATION SYSTEM AND THE IMAGING SYSTEM AND HALTED THE PROCEDURE, TO BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428410 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 Required Intervention