BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 22020577 · Received May 14, 2025

    Report

    Report Number
    2124215-2025-31059
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 18, 2025
    Report Date
    October 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 AND K210608

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 AND K210608. A SUPPLEMENTAL REPORT WAS INITIATED TO UPDATE THE H6 EVALUATION CONCLUSION CODES WITHIN THE 'DEVICE MANUFACTURERS ONLY' SECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A WOUND SITE INFECTION AND SEPSIS ASSOCIATED WITH THEIR INSERTABLE CARDIAC MONITOR (ICM) DEVICE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THE ICM DEVICE. A REPLACEMENT ICM DEVICE WAS SUBSEQUENTLY IMPLANTED. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. THE EXPLANTED ICM DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A WOUND SITE INFECTION AND SEPSIS ASSOCIATED WITH THEIR INSERTABLE CARDIAC MONITOR (ICM) DEVICE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THE ICM DEVICE. A REPLACEMENT ICM DEVICE WAS SUBSEQUENTLY IMPLANTED. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. THE EXPLANTED ICM DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO BSC, THEREFORE PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE PRIMARY REPORTED OBSERVATION IS ADDRESSED IN PRODUCT LABELING (E.G. INSTRUCTIONS FOR USE). THEREFORE, WELL-UNDERSTOOD FACTORS LIKELY CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND, ON THE DAY OF THE EXTRACTION, CONFIRMATION WAS PROVIDED THAT ALL COMPONENTS WERE BEING EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749050 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 155139 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R