BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 23341480 · Received October 20, 2025

    Report

    Report Number
    2124215-2025-74653
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    December 28, 2024
    Report Date
    October 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD G4 PREMARKET/510K, FROM SECTION G ALL MANUFACTURERS, CONTAINS BOTH DOCUMENTS K193473 AND K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) BECAUSE THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) BATTERY STATUS EARLIER THAN EXPECTED AND HAD NOT MET THE PROJECTED LONGEVITY. THE HCP WONDERED IF IT COULD BE RELATED TO THE ICM DEVICE SETTINGS. TS MENTIONED SETTINGS WERE NOT SUSPECTED TO BE THE CAUSE OF THE REPORTED BATTERY CONDITION AND REQUESTED ENGINEERING TO ANALYZE THE ICM DEVICE DATA. IN ADDITION, TS DISCUSSED THIS PATIENT WAS NO LONGER BEING MONITORED DUE TO THE REPORTED ISSUE. ANALYSIS OF ICM DEVICE DATA INDICATES THE BATTERY VOLTAGE DROPPED RAPIDLY A FEW MONTHS BEFORE THE RRT BATTERY STATUS OCCURRED. THE ROOT CAUSE IS UNKNOWN; HENCE, THE ICM DEVICE SHOULD BE RETURNED FOR A DETAILED ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM DEVICE REMAINS IMPLANTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801172 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 198995 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female