BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 22916146 · Received August 28, 2025

    Report

    Report Number
    2124215-2025-60693
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    February 28, 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
    MS, 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. 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.

    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 HOLD THE DEVICE AT OR ABOVE ROOM TEMPERATURE FOR 24 HOURS AND THEN TEST THE ICM BATTERY AGAIN. THE DEVICE WAS NEVER ATTEMPTED IMPLANT. THE FIELD REPRESENTATIVE TESTED THE ICM BATTERY AGAIN 24 HOURS LATER AND STILL RECEIVED THE LOW BATTERY MESSAGE. THE DEVICE HAS BEEN RETURNED AND ANALYSIS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247891 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 170204 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown