BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX INSERTABLE CARDIAC MONITOR

    MDR report key: 21621787 · Received March 17, 2025

    Report

    Report Number
    2124215-2025-16422
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    November 1, 2024
    Report Date
    March 17, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD G4 PREMARKET/510K FROM SECTION G ALL MANUFACTURERS, CONTAINS BOTH DOCUMENTS K193473 & K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE REASON BEHIND THIS DEVICE EXPLANT AND DEVICE RETURN STATUS. AS OF TODAY, REQUESTED INFORMATION HAS BEEN RECEIVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THEIR INSERTABLE CARDIAC MONITOR (ICM) DEVICE HAD BEEN EXPLANTED BECAUSE IT HAD NEVER PERFORMED AS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM DEVICE HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16631 LUX-DX INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 133642 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Hospitalization| R