BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 23568970 · Received November 17, 2025

    Report

    Report Number
    2124215-2025-83412
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 28, 2025
    Report Date
    May 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREMARKET FIELD G4 EXCEEDS THE CHARACTER LIMIT - THIS IS THE SECOND CODE: K210608.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED DUE TO PATIENT DISCOMFORT AND PATIENT REQUEST. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119260 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 172295

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Required Intervention| H