BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 12067715 · Received June 25, 2021

    Report

    Report Number
    3005075696-2021-00077
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    June 8, 2021
    Report Date
    August 9, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    HAW
    PMA / PMN Number
    K152041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE RBT DEVICE FOUND NO FAILURES AND THE DEVICE WAS WORKING AS INTENDED. 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.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ASM0113. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A BRAIN PROCEDURE TO PLACE LEADS. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING THE CASE. THE ENTRY POINT OF THE TRAJECTORY WAS ACCURATE, BUT THE TRAJECTORY WAS INACCURATE BY 3.3 MM. MULTIPLE STAR MARKER CTS WERE DONE AND THE LEAD WAS ABLE TO BE ACCURATELY PLACED. FOR THE SECOND LEAD, THE SURGEON HID THE FIRST TRAJECTORY AND USED THE REGULAR BASE FOR THE RBT DEVICE. THE SECOND LEAD WAS ON TRAJECTORY AND ACCURATE. THE MANUFACTURER REPRESENTATIVE NOTED THAT ONE OF THE SCANS WAS NON-CONTIGUOUS, BUT THEY WERE UNSURE IF THAT WOULD IMPACT THE SYSTEM. THE CAUSE OF THE DEVIATIONS WAS NOT DETERMINED, BUT THE SURGEON MENTIONED THERE HAD BEEN ONGOING INACCURACIES WITH THE RBT DEVICE. DURING THE CASE, THE SYSTEM WAS LAGGING AND BECAME UNRESPONSIVE. A SOFT REBOOT OF THE SYSTEM WAS DONE, BUT THE ISSUE WAS NOT RESOLVED AND THE SCREEN HAD GONE BLANK. THE O-ARM AND NAVIGATION WAS USED TO CONFIRM LEAD PLACEMENT. THE MANUFACTURER REPRESENTATIVE PLANNED TO REMOVE OLD CASES FROM THE SYSTEM AND REINSTALL THE SOFTWARE. THE RBT DEVICE WAS REPLACED AFTER THE CASE AND THE SYSTEM PASSED A 27 POINT ACCURACY CHECK. THE IMAGING SYSTEM WAS ALSO RECALIBRATED AS IT WAS OFF BY ABOUT 1 MM. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967752 RENAISSANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MAZOR ROBOTICS LTD TPL0038

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR