BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 23888078 · Received December 24, 2025

    Report

    Report Number
    2124215-2025-92904
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    December 18, 2025
    Report Date
    December 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S INSERTABLE CARDIAC MONITOR (ICM) WAS REMOVED DUE TO PAIN AND DISCOMFORT AT THE IMPLANT SITE. THE CALLER ASKED ABOUT THE PROPER HANDLING OF THE PATIENT MOBILE MONITOR (PMM). TECHNICAL SERVICES ADVISED THAT THE PMM CAN BE DISPOSED OF AS A STANDARD HOUSEHOLD ELECTRONIC DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453217 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 189216 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H