BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 PREMIUM

    MDR report key: 9786493 · Received March 4, 2020

    Report

    Report Number
    1723170-2020-00750
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 26, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2/H3/H6: THE SYSTEM WAS SERVICED IN THE FIELD AND PASSED ALL TESTS. NO FAILURES WERE FOUND. CODES 10, 213 AND 67 ARE APPLICABLE. H2/H3/H6: SOFTWARE ANALYSIS WAS DONE. LOGS INDICATED THAT THE REGISTRATIONS WERE FAILING DUE TO A LOW NUMBER OF POINTS (<100). THE USER COLLECTED A SMALL AMOUNT OF TRACE IN ONE LOCATION, STOPPED AND COLLECTED IN ANOTHER LOCATION CAUSING THE VOLUME BASED PROGRESS TO BE ACHIEVED WITH THIS SMALL AMOUNT OF POINTS. CODES 4112, 114 AND 19 ARE APPLICABLE TO THIS ANALYSIS. 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: SOFTWARE: SW APP 9735762, STEALTH S8 APP SOFTWARE VERSION: (B)(4). LOGS HAVE BEEN RECEIVED HOWEVER DEVICE EVALUATION HAS NOT BEEN COMPLETED AT THE TIME OF SUBMITTING THIS REPORT. 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 USED DURING A CRANIAL RESECTION. IT WAS REPORTED THAT THE SURGEON WAS HAVING DIFFICULTY REGISTERING. THE SURGEON ATTEMPTED THREE POINT REGISTRATION THREE TIMES AND WAS UNABLE TO PASS A REGISTRATION. THE PATIENT WAS POSITIONED LATERALLY. NAVIGATION WAS ABORTED. THERE WAS A PROCEDURE DELAY OF LESS THAN ONE HOUR AND NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250855 S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR