BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 25326511 · Received May 29, 2026

    Report

    Report Number
    2124215-2026-28834
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    March 24, 2025
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ICM WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. NEITHER VISUAL EXAMINATION NOR X-RAY EXAMINATION OF THE DEVICE IDENTIFIED ANOMALIES. THE DEVICE CASE WAS REMOVED TO FACILITATE INSPECTION AND TESTING OF THE INTERNAL COMPONENTS. THE BATTERY WAS REMOVED AND REPLACED WITH AN EXTERNAL POWER SOURCE. THE CURRENT DRAIN WAS MEASURED AND FOUND TO BE NORMAL. THE BATTERY WAS FORWARDED FOR DETAILED ANALYSIS. THIS ANALYSIS IDENTIFIED A LATENT CURRENT LEAKAGE PATH WITHIN THE BATTERY THAT RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION. 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. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF "CAUSE TRACED TO DEVICE DESIGN 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 THERE WERE NO FIELD ALLEGATIONS MADE AGAINST THE PERFORMANCE OF THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE. THE DEVICE WAS EXPLANTED AFTER BEING IMPLANTED AND IN-SERVICE FOR APPROXIMATELY 2 YEARS AND TWO MONTHS. THE DEVICE WAS RETURNED, AND DEVICE ANALYSIS WAS COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587315 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 162979 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1