BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH S8 PREMIUM

    MDR report key: 10091613 · Received May 27, 2020

    Report

    Report Number
    1723170-2020-01522
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 12, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2/H3/H6: THE SYSTEM WAS SERVICED IN THE FIELD A SECOND TIME. HARDWARE PARTS WERE REPLACED AND THE SYSTEM PASSED ALL TESTS. IT WAS CONFIRMED THAT REPLACING THE POWER CABLE FOR THE CAMERA CART RESOLVED THE ISSUE. CODES 10, 120 AND 4307 ARE APPLICABLE. H2/H3/H6: THE POWER CABLE WAS RETURNED AND ANALYZED. THE CABLE HAS NO PHYSICAL DAMAGE AND PASSED CONTINUITY TESTS WITH NO OPENS OR SHORTS DETECTED. NO PROBLEM WAS FOUND. PREVIOUSLY SUBMITTED CODES 10, 213 AND 67 ARE APPLICABLE. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: CABLE 9735842 CAM MON PWR 12VDC S8 SVC, LOT NUMBER: 180327. 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

    ADDITIONAL INFORMATION: PATIENT INFORMATION WAS RECEIVED. ADDITIONAL EVENT INFORMATION WAS RECEIVED. DEVICE EVALUATION: A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO EVALUATE THE EQUIPMENT, AND NO FAILURES WERE FOUND. CODES METHOD/RESULT/CONCLUSION, ARE APPLICABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735843, SERIAL/LOT #: UNK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT IT IS UNKNOWN IF IT WAS THE CAMERA CART OR MAIN CART MONITOR THAT WENT BLACK. IT WAS CLARIFIED THAT THE ISSUE WAS INTERMITTENT BLACK SCREEN WITH ARM MOVEMENT, AND THAT THE LIKELY CAUSE IF THE POWER CABLE BEING PINCHED. THERE WERE NO ISSUES WITH THE CAMERA.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SCREEN WENT BLACK DURING THE CASE. THIS OCCURRED AFTER ADJUSTING THE CAMERA. THIS DID NOT AFFECT THE PROCEDURE. THERE WAS A DELAY OF LESS THEN 1 HOUR AND THERE WAS NO REPORTED HARM TO THE PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555611 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR