BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 7385559 · Received March 30, 2018

    Report

    Report Number
    1723170-2018-01404
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    March 7, 2018
    Report Date
    March 6, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6) THE SOFTWARE INVESTIGATION FOUND THAT BOTH THE INSTRUMENT AND THE REFERENCE FRAME BECAME BLOCKED, AND HAD RED STATUS AT DIFFERENT TIMES. THE JUMPS IN NAVIGATION OCCUR AFTER NAVIGATION IS STOPPED, THE INSTRUMENT IS MOVED, AND THE INSTRUMENT OR FRAME BECOMES VISIBLE TO THE CAMERA. THE SOFTWARE FUNCTIONED AS DESIGNED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    H2) CORRECTION: THE PASSIVE BLUNT PROBE WAS FURTHER ANALYZED AND IT WAS FOUND THAT THE PROBE WAS PERFORMING AS EXPECTED. THERE WAS NO ISSUE FOUND WITH THE PROBE AND IT WAS FOUND TO BE WITHIN THE EXPECTED ACCURACY CRITERION WHEN TESTED. H10) THE EVENT REPORTED IN THIS 3500A ALSO REPRESENTS A POTENTIAL ACCIDENTAL RADIATION OCCURRENCE (ARO) PER 21 CFR 1002.20(A). PER 21 CFR 1002.20(C), THIS EVENT IS ALSO BEING REPORTED UNDER PART 803. SUPPLEMENTAL ARO INFORMATION IS AS FOLLOWS: DOSE INFORMATION NOT AVAILABLE. ESTIMATED ABSORBED DOSE TO PATIENT BASED ON UNUTILIZED RADIATION IS = 12.5 MSV (NEGLIGIBLE). 1 - PATIENT TOTAL NUMBER OF PEOPLE IN OR UNKNOWN. (B)(6) . MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS ELECTRONICALLY RESUBMITTED PER FDA REQUEST. IN THIS INSTANCE, THE REPORT FOLLOW-UP SEQUENCE WAS APPARENTLY OUT OF ORDER DUE TO DATA CONVERSION AND LIKELY REDUNDANT, AS THERE IS NO SUBSTANTIVE INFORMATION TO ADD AT THIS TIME. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT THE INFORMATION ABOUT OTHER INSTRUMENTS JUMPING AROUND IN THE INITIAL REPORT IS INCORRECT. IT WAS JUST THE PROBE DOING THIS. THE PROBE WAS INSPECTED PRIOR TO USE AND THE SITE EVEN DECIDED TO USE A NEW PROBE FROM A SECOND TRAY. THE PROBE WAS USED PRIOR TO THE PEDICLE HOLE BEING DRILLED AND NAVIGATION WAS USED WHILE DRILLING. IT WAS ALSO REPORTED THAT THE SURGEON FREQUENTLY CHECKED THE ACCURACY THROUGHOUT THE PROCEDURE AND THE IMPRECISION OF THE L5 SCREW WAS ABOUT 3-5MM. THE SURGEON WAS NOT ABLE TO PLACE THE SCREW, HE STOPPED NAVIGATING AND SWITCHED TO A DIFFERENT NAVIGATION SYSTEM.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE REPRESENTATIVE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. A PROBE FROM THE SITE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS REPORTED THAT THE PROBE RETURNED HIGH GEOMETRIC ERRORS WHEN VERIFIED ON A KNOWN OPERATIONAL NAVIGATION SYSTEM. IT WAS REPORTED THAT THE TIP OF THE PROBE WAS SLIGHTLY BENT. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. A SECOND PROBE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, AN IMPRECISION WAS OBSERVED RESULTING IN A LEFT L5 SCREW BEING MISPLACED AND REQUIRING REVISION. PRIOR TO THE IMPRECISION BEING OBSERVED, IT WAS NOTED THAT THE PEDICLE PROJECTION IN THE APPLICATION SOFTWARE WAS NOTED TO "JUMP" INTO THE SPINAL CANAL. IT WAS REPORTED THAT THE "JUMPING" ISSUE CARRIED ACROSS MULTIPLE INSTRUMENTS. A SECOND IMAGE ACQUISITION WAS PERFORMED AND A NEW REFERENCE FRAME WAS ATTACHED WITH MINOR RESOLUTIONS. A CONFIRMATION IMAGE ACQUISITION WITH A C-ARM IDENTIFIED THE MISPLACEMENT. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF TWENTY MINUTES DUE TO THIS ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229078 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention