BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT TRACKER 9734887XOM NON-INVASIVE

    MDR report key: 18531745 · Received January 17, 2024

    Report

    Report Number
    1723170-2024-00163
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    October 13, 2022
    Report Date
    January 18, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K141833
    Removal / Correction Number
    Z-1039-2023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D) A TOTAL OF 3 OF 9 INSTRUMENTS WITH THE LOT NUMBER 220729 WERE REPORTED TO EXPERIENCE THE ISSUE DESCRIBED IN SECTION B5. H3, H6) THE TRACKERS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE THREE OPENED TRACKERS WOULD NOT TRACK WHEN CONNECTED TO A KNOWN GOOD SYSTEM DISPLAYING ONLY RED STATUS. THE SIX UNOPENED WERE NOT TESTED. CODES B01, C13, AND D02 ARE APPLICABLE. H3, H6) D03 WAS CODED AS WELL DUE TO A CONFIRMED MANUFACTURING ISSUE. 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. 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

    H2) CORRECTION MADE TO B5. 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. 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 REGARDING A NAVIGATION SYSTEM USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT DURING A PROCEDURE, THE REGISTRATION PROBE WAS NOT ABLE TO VERIFY. SWAPPED TO A SECOND, AND THEN A THIRD PATIENT TRACKER WITH NO RESOLUTION. ALL THREE TRACKERS WERE OF THE SAME LOT. THE PROCEDURE WAS COMPLETED WITHOUT THE AID OF NAVIGATION. THE MANUFACTURER REPRESENTATIVE NOTED THAT THEY COULD VISIBLE SEE THAT THE DIVOT WAS OFF-CENTER ON THE TRACKERS. NO IMPACT ON PATIENT OUTCOME. NO DELAY IN THE SURGICAL PROCEDURE.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT DURING A PROCEDURE, THE REGISTRATION PROBE WAS NOT ABLE TO VERIFY. SWAPPED TO A SECOND, AND THEN A THIRD PATIENT TRACKER WITH NO RESOLUTION. ALL THREE TRACKERS WERE OF THE SAME LOT. THE PROCEDURE WAS COMPLETED WITHOUT THE AID OF NAVIGATION. THE MANUFACTURER REPRESENTATIVE NOTED THAT THEY COULD VISIBLE SEE THAT THE DIVOT WAS OFF-CENTER ON THE TRACKERS. NO IMPACT ON PATIENT OUTCOME. NO DELAY IN THE SURGICAL PROCEDURE. IT WAS NOTED THAT THERE WERE 6 ADDITIONAL PATIENT TRACKERS OF THE SAME LOT THAT WERE UNOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818679 PATIENT TRACKER 9734887XOM NON-INVASIVE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9734887XOM 220729

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male