BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 22102416 · Received May 28, 2025

    Report

    Report Number
    2124215-2025-34913
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    March 20, 2023
    Report Date
    February 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. AN ATTEMPT WAS MADE TO INTERROGATE THE DEVICE, AND IT WAS NOTED THE ICM COULD NOT BE COMMUNICATED WITH. 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. PLEASE NOTE THAT THIS DEVICE HAS TWO PREMARKET / 510(K) NUMBERS: K193473, K210608.

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLEASE NOTE THAT THIS DEVICE HAS TWO PREMARKET / 510(K) NUMBERS: K193473, K210608.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) RECORDED SEVERAL EVENTS SINCE IMPLANT WITH EVIDENCE OF NOISE OVERSENSING THAT APPEARED TO BE CAUSED BY MOVEMENT OR MUSCLE NOISE. CONSEQUENTLY, THE DEVICE WAS EXPLANTED. A NEW ICM WAS IMPLANTED INSTEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) RECORDED EVENTS SINCE IMPLANT WITH EVIDENCE OF NOISE OVERSENSING THAT APPEARED TO BE CAUSED BY MOVEMENT OR MUSCLE NOISE. CONSEQUENTLY, THE DEVICE WAS EXPLANTED. A NEW ICM WAS IMPLANTED INSTEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994022 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 168489 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention| H