BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX INSERTABLE CARDIAC MONITOR

    MDR report key: 16038094 · Received December 22, 2022

    Report

    Report Number
    2124215-2022-54576
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    December 14, 2022
    Report Date
    May 15, 2023
    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
    CO, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RETURNED FOR ANALYSIS AND PRODUCT INVESTIGATION COMPLETED. ANALYSIS FOUND EVIDENCE OF LITHIUM CLUSTERS IN THE BATTERY, WHICH CREATES ELECTRICAL SHORTING. AS A RESULT, EVALUATION CONCLUSION CODE "CAUSE TRACED TO DEVICE DESIGN" WAS SELECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE WAS EXPLANTED AND REPLACED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECEIVED A CALL FROM THE PATIENT REQUESTING TROUBLESHOOTING ASSISTANCE. THE PATIENT COULD NOT CONNECT THE PATIENT MOBILE MONITOR (PMM) TO THE ICM DEVICE. TS REFERRED THE PATIENT TO FOLLOW UP WITH THEIR HEALTHCARE FACILITY (HCF). THE HCF SAW THE PATIENT FOR A DEVICE CHECK. THE HCF ATTEMPTED TO CONNECT THE PMM AND ICM MULTIPLE TIMES BUT FAILED. THE HCF SCHEDULED AND EXPLANT PROCEDURE TO REPLACE THE DEVICE. ADDITIONAL INFORMATION FROM THE BOSTON SCIENTIFIC REPRESENTATIVE PROVIDED THE ICM DEVICE COULD NOT BE WOKE UP USING THE PMM OR THE CLINIC MOBILE MONITOR (CMM). THE ICM DEVICE WOULD NOT CONNECT TO ANY DEVICE TO BE INTERROGATED. SUBSEQUENTLY THE ICM DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC ICM DEVICE WITHOUT ISSUE. THE BOSTON SCIENTIFIC REPRESENTATIVE PROVIDES THE ICM DEVICE WILL BE RETURNED FOR ANALYSIS. THE HCF PROVIDES THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE WAS EXPLANTED AND REPLACED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECEIVED A CALL FROM THE PATIENT REQUESTING TROUBLESHOOTING ASSISTANCE. THE PATIENT COULD NOT CONNECT THE PATIENT MOBILE MONITOR (PMM) TO THE ICM DEVICE. TS REFERRED THE PATIENT TO FOLLOW UP WITH THEIR HEALTHCARE FACILITY (HCF). THE HCF SAW THE PATIENT FOR A DEVICE CHECK. THE HCF ATTEMPTED TO CONNECT THE PMM AND ICM MULTIPLE TIMES BUT FAILED. THE HCF SCHEDULED AND EXPLANT PROCEDURE TO REPLACE THE DEVICE. ADDITIONAL INFORMATION FROM THE BOSTON SCIENTIFIC REPRESENTATIVE PROVIDED THE ICM DEVICE COULD NOT BE WOKE UP USING THE PMM OR THE CLINIC MOBILE MONITOR (CMM). THE ICM DEVICE WOULD NOT CONNECT TO ANY DEVICE TO BE INTERROGATED. SUBSEQUENTLY THE ICM DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC ICM DEVICE WITHOUT ISSUE. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THE HCF PROVIDED THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614194 LUX-DX INSERTABLE CARDIAC MONITOR Recorder, event, implantable cardiac, (with arrhythmia detection) MXD BOSTON SCIENTIFIC CORPORATION M301 128238 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Other| H