BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX INSERTABLE CARDIAC MONITOR

    MDR report key: 20993521 · Received December 20, 2024

    Report

    Report Number
    2124215-2024-81204
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    December 2, 2024
    Report Date
    April 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. VISUAL EXAMINATION OF THE DEVICE IDENTIFIED 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. FIELD G4 PREMARKET/510K CONTAINS BOTH DOCUMENTS K193473 AND K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    FIELD G4 PREMARKET/510K CONTAINS BOTH DOCUMENTS K193473 AND 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) WAS EXPLANTED BECAUSE IT BEGAN INTERFERING WITH THE PACEMAKER ALSO IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. DUE DILIGENCE HAS BEEN COMPLETED. THIS ICM HAS BEEN RETURNED AND ANALYSIS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED BECAUSE IT BEGAN INTERFERING WITH THE PACEMAKER ALSO IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED AT THIS TIME. THIS ICM HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390213 LUX-DX INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 178772

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization