BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 23786433 · Received December 12, 2025

    Report

    Report Number
    2124215-2025-90533
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # FIELD ON 3500A FORM CONTAINS AN ADDITIONAL CODE - 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 DUE TO PRODUCT PERFORMANCE ISSUE AS THE DEVICE REACHED THE END OF SERVICE (EOS) STATUS. IT WAS INDICATED THAT THE ICM WAS NO LONGER NEEDED, NO REPLACEMENT WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769239 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 162237

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Unknown Hospitalization| R