BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 22916282 · Received August 28, 2025

    Report

    Report Number
    2124215-2025-60694
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    March 17, 2023
    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
    MA, US
    Reporter Occupation
    OTHER

    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. 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 THIS INSERTABLE CARDIAC MONITOR (ICM) PROVIDED A LOW BATTERY WARNING PRIOR TO IMPLANT. TECHNICAL SERVICES (TS) ADVISED THE FIELD REPRESENTATIVE TO RETURN THE ICM DEVICE FOR ANALYSIS. THE DEVICE WAS NEVER ATTEMPTED IMPLANT. THE FIELD REPRESENTATIVE PROVIDED THEY WILL RETURN THE DEVICE FOR ANALYSIS. SUBSEQUENTLY, THE ICM WAS RETURNED AND ANALYSIS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086334 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 172090 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown