BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 24381413 · Received February 18, 2026

    Report

    Report Number
    2124215-2026-09181
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    December 15, 2025
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 AND K210608. PATIENT INITIAL REPORTER EMAIL NOT AVAILABLE. EMAIL NOT GIVEN WHEN INITIAL REQUESTED ON GMDT PAPERWORK, PATIENT DECIDED NOT TO GIVE EMAIL TO BSC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEW PATIENT MOBILE MONITOR (PMM) WAS RECEIVED BY THE PATIENT, AND PAIRING WAS RELEASED AGAIN. THE MAGNET ATTACHMENT PROCESS WAS WALKED THROUGH, AND SETUP WAS ATTEMPTED BUT REMAINED INCOMPLETE, RESULTING IN DISABLED MONITORING DUE POSSIBLE DEVICE ISSUE. THE PATIENT RECEIVED EDUCATION ON THE INSERTABLE CARDIAC MONITOR BATTERY LIFE AND WAS REFERRED TO THE CLINIC FOR FURTHER EVALUATION. THE ICM REMAINS IN SERVICE, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION REQUESTED ABOUT THE BATTERY LIFE, AND THE CASE WAS REFERRED TO THE CLINIC FOR FURTHER EVALUATION. HOWEVER, THE INFORMATION COULD NOT BE PROVIDED DUE TO UNAVAILABILITY FROM THE CUSTOMER/ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317967 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 145385 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Unknown