BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 23343331 · Received October 20, 2025

    Report

    Report Number
    2124215-2025-74838
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    October 1, 2025
    Report Date
    May 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 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 THIS INSERTABLE CARDIAC MONITOR (ICM) WAS REMOVED FROM THE PATIENT FOR AN UNSPECIFIED REASON. NO FURTHER DETAILS WERE PROVIDED REGARDING THE CAUSE OR CONDITION LEADING TO THE EXPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28121 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 156585 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization| R