BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGN CART 9735665 STEALTH S8 PREMIUM

    MDR report key: 10233242 · Received July 6, 2020

    Report

    Report Number
    1723170-2020-01833
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 14, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT THE SITE USED ANOTHER SYSTEM THAT DID HAVE FAILURES TO COMPLETE THE SURGERY. A STEALTHSTATION IMAGE GUIDANCE NAVIGATION SYSTEM WAS BEING USED. FIRMWARE FAULT ERROR WAS FOUND ON THE CAMERA. CAMERA WAS REPLACED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CAMERA 9735821 VEGA BASE S8 SVC, LOT # P900946. A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO EVALUATE THE EQUIPMENT. HARDWARE PARTS WERE REPLACED. (B)(4) ARE APPLICABLE. THE RETURNED CAMERA WAS ANALYZED BY A MEDTRONIC REPRESENTATIVE. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY. THERE WAS ALSO INTERMITTENT ISSUES WITH ILLUMINATOR CURRENT LOW. OTHERWISE, THE PSU PASSED AN ACCURACY TEST (AAK) AT .23 MM WITH A PASSING THRESHOLD OF .25 MM. (B)(4) ARE APPLICABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT WHILE SETTING UP FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE, THE CAMERA DISPLAYED "LOCALIZER NOT CONNECTED." THE SITE REBOOTED SEVERAL TIMES WITH NO RESOLUTION. THEY SWITCHED TO ANOTHER SYSTEM FOR THE REMAINDER OF THE PROCEDURE "BUT IT WAS BEING USED." THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698913 SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR