BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 24492166 · Received March 2, 2026

    Report

    Report Number
    2124215-2026-11560
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 31, 2026
    Report Date
    May 8, 2026
    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

    G4: PMA/510(K) # FIELD ON 3500A FORM IS K193473, K210608 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR DEVICE WAS FLAGGED AS REACHING ITS END-OF-SERVICE STATUS EARLIER THAN EXPECTED, INDICATING IT DID NOT ACHIEVE ITS ANTICIPATED LONGEVITY PERIOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298830 LUX-DX? INSERTABLE CARDIAC MONITOR RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION) MXD BOSTON SCIENTIFIC CORPORATION M301 170682 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown