BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 23865370 · Received December 22, 2025

    Report

    Report Number
    2124215-2025-92322
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 2, 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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 & K210608. SUPLEMENTAL 01: REPORT THE RESULTS OF THE DEVICE EVALUATION: THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF PREMATURE DISCHARGE OF BATTERY WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. AND REVIEW OF LABELING DETERMINED THAT THE COMPLAINT SITUATION WAS LISTED IN THE MANUAL. THERE WAS NO INDICATION IN THE COMPLAINT THAT THE PRODUCT WAS NOT USED IN ACCORDANCE TO LABELING. THE MANUAL WAS UNLIKELY TO BE THE CAUSE OF THE REPORTED COMPLAINT; TRANSLATION, WORDING, OR GRAPHICS DOES NOT REQUIRE FURTHER REVIEW. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF "CAUSE NOT ESTABLISHED".

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 & K210608.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) REACHED END OF SERVICE, LEADING TO A SUSPENSION OF TRANSMISSIONS EVENT DUE TO POSSIBLE EARLY DEPLETION OF THE ICM. CONNECTIVITY ATTEMPTS THROUGH THE PMM APP WERE UNSUCCESSFUL, AND THE APPLICATION STATUS SHOWED 'SUSPENDED.' THE SITUATION REMAINS UNRESOLVED AND HAS BEEN REFERRED TO THE CLINIC FOR DIRECT EVALUATION OF THE ICM. THE ICM REMAINS IN SERVICE, AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) REACHED END OF SERVICE, LEADING TO A SUSPENSION OF TRANSMISSIONS EVENT DUE TO POSSIBLE EARLY DEPLETION OF THE ICM. CONNECTIVITY ATTEMPTS THROUGH THE PMM APP WERE UNSUCCESSFUL, AND THE APPLICATION STATUS SHOWED 'SUSPENDED.' THE SITUATION REMAINS UNRESOLVED AND HAS BEEN REFERRED TO THE CLINIC FOR DIRECT EVALUATION OF THE ICM. THE ICM REMAINS IN SERVICE, AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229776 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 193458

    Patients

    Seq Age Sex Outcome Treatment
    1