BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX INSERTABLE CARDIAC MONITOR

    MDR report key: 20758969 · Received November 22, 2024

    Report

    Report Number
    2124215-2024-73856
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    July 27, 2023
    Report Date
    August 5, 2025
    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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD G4 PREMARKET/510K CONTAINS BOTH DOCUMENTS K193473 & K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD.

    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 DID NOT REVEAL ANY ABNORMALITIES. 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) DEVICE COULD NOT BE CONNECTED TO. THE PATIENT WAS SEEN AT THE CLINIC AND THE HEALTHCARE PROFESSIONAL (HCP) COULD NOT PAIR TO THE ICM USING THE PATIENT MOBILE MONITOR (PMM) OR THE CLINIC MOBILE MONITOR (CMM). TECHNICAL SERVICES (TS) ADVISED THE ICM DEVICE BATTERY HAS POTENTIALLY DEPLETED PREMATURELY. SUBSEQUENTLY, THIS ICM WAS EXPLANTED. ANOTHER ICM WAS IMPLANTED TO CONTINUE MONITORING. THIS ICM HAS NOT BEEN RETURNED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE COULD NOT BE CONNECTED TO. THE PATIENT WAS SEEN AT THE CLINIC AND THE HEALTHCARE PROFESSIONAL (HCP) COULD NOT PAIR TO THE ICM USING THE PATIENT MOBILE MONITOR (PMM) OR THE CLINIC MOBILE MONITOR (CMM). TECHNICAL SERVICES (TS) ADVISED THE ICM DEVICE BATTERY HAS POTENTIALLY DEPLETED PREMATURELY. SUBSEQUENTLY, THIS ICM WAS EXPLANTED. ANOTHER ICM WAS IMPLANTED TO CONTINUE MONITORING. SUBSEQUENTLY, THIS ICM HAS BEEN RETURNED AND ANALYSIS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606123 LUX-DX INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 138518 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R