BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 21816745 · Received April 10, 2025

    Report

    Report Number
    2124215-2025-22654
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 24, 2025
    Report Date
    May 29, 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
    NH, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD G4 PREMARKET/510K FROM SECTION G ALL MANUFACTURERS, CONTAINS BOTH DOCUMENTS K193473 AND K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SCHEDULED INSERTABLE CARDIAC MONITOR (ICM) DEVICE REPLACEMENT PROCEDURE, AFTER THE SURGICAL INCISION TO REMOVE THE IMPLANTED INSERTABLE CARDIAC MONITOR (ICM) DEVICE WAS MADE, THE ICM DEVICE COULD NOT BE REMOVED FROM THE PATIENT, SINCE IT WAS TOO DEEP INSIDE THE TISSUE. IT WAS NOTED THAT THE DEVICE HAD BEEN PALPATED PRIOR TO MAKING THE INCISION; HOWEVER, ONCE THE SURGICAL INCISION WAS MADE, IT COULD NOT BE REMOVED. THE HEALTH CARE PROFESSIONAL (HCP) THEREFORE DECIDED TO RESCHEDULE THE PROCEDURE AND PLANS TO REMOVE THIS ICM DEVICE, UNDER THE GUIDANCE OF AN X-RAY, IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM DEVICE REMAINS IMPLANTED IN THE PATIENT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SCHEDULED INSERTABLE CARDIAC MONITOR (ICM) DEVICE REPLACEMENT PROCEDURE, AFTER THE SURGICAL INCISION TO REMOVE THE IMPLANTED INSERTABLE CARDIAC MONITOR (ICM) DEVICE WAS MADE, THE ICM DEVICE COULD NOT BE REMOVED FROM THE PATIENT, SINCE IT WAS TOO DEEP INSIDE THE TISSUE. IT WAS NOTED THAT THE DEVICE HAD BEEN PALPATED PRIOR TO MAKING THE INCISION; HOWEVER, ONCE THE SURGICAL INCISION WAS MADE, IT COULD NOT BE REMOVED. THE HEALTH CARE PROFESSIONAL (HCP) THEREFORE DECIDED TO RESCHEDULE THE PROCEDURE AND PLANS TO REMOVE THIS ICM DEVICE, UNDER THE GUIDANCE OF AN X-RAY, IN THE FUTURE. ADDITIONAL INFORMATION INDICATES THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE WAS SUCCESSFULLY EXPLANTED FROM THE PATIENT, DUE TO NORMAL BATTERY DEPLETION, USING X-RAY IMAGING. A NEW ICM DEVICE WAS IMPLANTED AS REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED ICM DEVICE IS NOT AVAILABLE FOR RETURN, SINCE IT WAS DISCARDED BY THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518753 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 135180 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention| H