BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX INSERTABLE CARDIAC MONITOR

    MDR report key: 15285148 · Received August 24, 2022

    Report

    Report Number
    2124215-2022-32344
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    August 12, 2022
    Report Date
    August 24, 2022
    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
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELT A STABBING AND BURNING SENSATION AT THE INSERTABLE CARDIAC MONITOR (ICM) DEVICE SITE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECEIVED A CALL FROM THE PATIENT AND ADVISED THE PATIENT TO CONTACT THEIR PHYSICIAN OR GO TO THE EMERGENCY ROOM (ER). ADDITIONAL INFORMATION PROVIDED INDICATES AFTER THE PATIENT PLACED THEIR CALL TO TS, THE PATIENT WAS ABLE TO GET IN CONTACT WITH A PHYSICIAN. THE PHYSICIAN ADVISED THE PATIENT TO MONITOR FOR ANY SIGNS OF INFECTION AT HOME. THE HEALTHCARE FACILITY (HCF) HAD A SCHEDULED FOLLOW UP CALL WITH THE PATIENT BUT WERE NOT ABLE TO SUCCESSFULLY CONNECT. THERE HAVE BEEN NO SUBSEQUENT CALLS TO TS OR THE HCF, AND THERE ARE NO DOCUMENTED VISITS TO THE HCF OR ER. ALSO, THE ICM DEVICE IS OPERATING AND TRANSMITTING AS INTENDED. THE ICM DEVICE IS NOT EXPECTED TO BE EXPLANTED AS A RESULT OF THE PATIENT REPORTED SYMPTOMS. THE DEVICE REMAINS IN-SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325025 LUX-DX INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 155800 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Unknown Other