BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 22801304 · Received August 13, 2025

    Report

    Report Number
    2124215-2025-56717
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # FIELD ON 3500A FORM IS K193473 & K210608; REPORTED HERE AS IT EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED AS IT REACHED THE END OF SERVICE (EOS) AFTER 2 YEARS OF BEING IMPLANTED. THE ICM IS NOT EXPECTED TO BE RETURNED AS IT WAS DISCARDED. NO NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956146 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 186504 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Hospitalization| R