BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM S-ICD

    MDR report key: 21163561 · Received January 15, 2025

    Report

    Report Number
    2124215-2025-01615
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 16, 2024
    Report Date
    February 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT REMAINS IMPLANTED; THEREFORE, TECHNICAL ANALYSIS CANNOT BE CONDUCTED. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ELECTRODE EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCE SINCE IMPLANT, CURRENTLY MEASURING 225 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND CONFIRMED SHOCK IMPEDANCE HAS MEASURED APPROXIMATELY 100-200 OHMS SINCE IMPLANT IN 2021. THE GRADUAL RISE TO 200-235 OHMS IS SUSPECTED TO BE DUE TO SYSTEM MIGRATION (THE SYSTEM IS NO LONGER ON FACIAL PLANE BUT FREELY MOVING IN ADIPOSE TISSUE). ADDITIONALLY, AMPLITUDES SHOW A WIDE RANGE BETWEEN 0.9-2.2 MILLIVOLTS (MV) WHICH COULD ALSO BE SUGGESTIVE OF FREE SYSTEM PARTS MOVING IN ADIPOSE TISSUE). THE HEALTH CARE PROFESSIONAL (HCP) WAS ADVISED TO INVESTIGATE ANY PATIENT LIFESTYLE CHANGES (I.E., EXTREME PHYSICAL ACTIVITIES, SPORTS, UNDERLYING DISEASE, FREQUENT WEIGHT CHANGES, MEDICAL INTERVENTIONS, ETC.). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ELECTRODE EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCE SINCE IMPLANT, CURRENTLY MEASURING 225 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND CONFIRMED SHOCK IMPEDANCE HAS MEASURED APPROXIMATELY 100-200 OHMS SINCE IMPLANT IN 2021. THE GRADUAL RISE TO 200-235 OHMS IS SUSPECTED TO BE DUE TO SYSTEM MIGRATION (THE SYSTEM IS NO LONGER ON FACIAL PLANE BUT FREELY MOVING IN ADIPOSE TISSUE). ADDITIONALLY, AMPLITUDES SHOW A WIDE RANGE BETWEEN 0.9-2.2 MILLIVOLTS (MV) WHICH COULD ALSO BE SUGGESTIVE OF FREE SYSTEM PARTS MOVING IN ADIPOSE TISSUE). THE HEALTH CARE PROFESSIONAL (HCP) WAS ADVISED TO INVESTIGATE ANY PATIENT LIFESTYLE CHANGES (I.E., EXTREME PHYSICAL ACTIVITIES, SPORTS, UNDERLYING DISEASE, FREQUENT WEIGHT CHANGES, MEDICAL INTERVENTIONS, ETC.). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177207 EMBLEM S-ICD SUBCUTANEOUS DEFIB ELECTRODE LWS BOSTON SCIENTIFIC CORPORATION 3501 197773

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown