BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 22919607 · Received August 28, 2025

    Report

    Report Number
    2124215-2025-60796
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    July 16, 2025
    Report Date
    January 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # FIELD ON 3500A FORM IS K193473, K210608 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # FIELD ON 3500A FORM IS K193473, K210608 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE INSERTABLE CARDIAC MONITOR (ICM) WAS INSPECTED AND ANALYZED. VISUAL EXAMINATION NOTED NO ANOMALIES. THE CURRENT DRAIN WAS MEASURED AND FOUND TO BE NORMAL. DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED AS PATIENT REQUESTED DUE TO SKIN DISCOMFORT. NO NEW DEVICE WAS IMPLANTED. 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 PATIENT REQUEST DUE TO SKIN DISCOMFORT. NO NEW DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314680 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 129715 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Unknown Hospitalization| R