BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 22916479 · Received August 28, 2025

    Report

    Report Number
    2124215-2025-60700
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    January 8, 2024
    Report Date
    August 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. FIELD G4 PREMARKET/510K CONTAINS BOTH DOCUMENTS K193473 & K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS DIFFICULTLY PAIRING THE INSERTABLE CARDIAC MONITOR (ICM) AND EXTERNAL DEVICES AT INITIAL SETUP. THE FIELD REPRESENTATIVE REPORTED THE ICM DEVICE WOULD NOT PAIR WITH THEIR CLINIC MOBILE MONITOR. THE FIELD REPRESENTATIVE TRIED MULTIPLE TIMES BUT WERE UNSUCCESSFUL. THE FIELD REPRESENTATIVE THEN USED A DIFFERENT ICM DEVICE AND WERE ABLE TO PAIR SUCCESSFULLY. THAT DEVICE WAS SUBSEQUENTLY SUCCESSFULLY IMPLANTED. THIS ICM HAS BEEN RETURNED AND ANALYSIS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828101 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 180821 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male