BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX INSERTABLE CARDIAC MONITOR

    MDR report key: 20606247 · Received November 5, 2024

    Report

    Report Number
    2124215-2024-69278
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    September 24, 2024
    Report Date
    April 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE INSERTABLE CARDIAC MONITOR (ICM) WAS INSPECTED AND ANALYZED. VISUAL EXAMINATION NOTED NO ANOMALIES. TESTING WAS COMPLETED TO ASSESS SENSING AND DEVICE FUNCTIONALITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. CHARACTER LIMIT LENGTH AT G4 - THESE ARE THE FULL RESULTS: K193473 & K210608.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED AS THE PATIENT SUFFERED FROM PAIN AT IMPLANT SITE. THE ICM HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED AS THE PATIENT SUFFERED FROM PAIN AT IMPLANT SITE. THE ICM HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72982 LUX-DX INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 200418

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| H