BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 23159214 · Received September 26, 2025

    Report

    Report Number
    2124215-2025-68186
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) REACHED THE END OF SERVICE (EOS) STATUS, THUS THE PHYSICIAN WAS UNABLE TO INTERROGATE THE DEVICE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THAT THE ONLY SOLUTION WAS TO REPLACE THE DEVICE AND RETURN IT FOR FURTHER ANALYSIS. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICM HAS BEEN EXPLANTED. A NEW ICM HAS BEEN RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936616 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 182865

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Required Intervention| H