BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACING SYSTEM ANALYZER

    MDR report key: 22033866 · Received May 16, 2025

    Report

    Report Number
    2182208-2025-02395
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 28, 2025
    Report Date
    September 10, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    UDI-DI
    00721902256011
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER'S COMMENT THAT THE DIAGNOSTIC MESSAGE WAS DISPLAYED BY THE PROGRAMMER, THAT INDICATED THAT IT WAS UNABLE TO CONNECT WITH THE ANALYZER. AN INCOMING INSPECTION WAS PERFORMED ON THE ANALYZER, THE UNIT WAS OPENED, AND A VISUAL INSPECTION WAS PERFORMED AND ACCESSED. THE ANALYZER FUNCTIONED AS REQUIRED WITHOUT ANY ISSUE. THE ANALYZER THEN PASSED ALL FINAL FUNCTIONAL AND SYSTEMS TESTS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DIAGNOSTIC MESSAGE WAS DISPLAYED BY THE PROGRAMMER THAT INDICATED THAT IT WAS UNABLE TO CONNECT WITH THE ANAL YZER. THE ANALYZER WAS CHANGED OUT FOR ANOTHER ANALYZER MODULE, AFTER WHICH NO FURTHER ISSUE WAS OBSERVED. IT WAS FURTHER PROVIDED THAT THE ANALYZER WAS NON-FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881524 PACING SYSTEM ANALYZER PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 229047 00721902256011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 2090 PROGRAMMER