BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 16981260 · Received May 22, 2023

    Report

    Report Number
    2124215-2023-25505
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    May 15, 2023
    Report Date
    June 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526599200
    PMA / PMN Number
    P110042/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: CODE AMENDED ON H6 DEVICE CODES: A072202.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ELECTRODE EXHIBITED LOW IMPEDANCES OUT OF RANGE AFTER IMPLANT PROCEDURE. TECHNICAL SERVICES (TS) DISCUSSED REASONS FOR LOWER IMPEDANCE (FLUIDS ON BOARD, ANTERIOR CAN, SMALLER PATIENT). THE FIELD REPRESENTATIVE INDICATED THAT THE PATIENT IS NOT SMALL/NARROW CHESTED, THERE WAS NO FLUID IN THE POCKET AND A POSSIBLE SMALL AMOUNT OF PERICARDIAL FLUID. TECHNICAL SERVICES (TS) SUGGESTED A SHOCK TO MEASURE ACTUAL IMPEDANCE AND DEFIBRILLATION THRESHOLD (DFT) TEST TO CONFIRM ABILITY TO CONVERT VENTRICULAR FIBRILLATION (VF). A SHOCK WAS DELIVERED, AND THE SHOCK LEAD IMPEDANCES WERE STILL LOW BUT WITHIN NORMAL LIMITS. THE PLAN IS TO PERFORM DFT AT A LATER TIME. THIS ELECTRODE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ELECTRODE EXHIBITED LOW IMPEDANCES OUT OF RANGE AFTER IMPLANT PROCEDURE. TECHNICAL SERVICES (TS) DISCUSSED REASONS FOR LOWER IMPEDANCE (FLUIDS ON BOARD, ANTERIOR CAN, SMALLER PATIENT). THE FIELD REPRESENTATIVE INDICATED THAT THE PATIENT IS NOT SMALL/NARROW CHESTED, THERE WAS NO FLUID IN THE POCKET AND A POSSIBLE SMALL AMOUNT OF PERICARDIAL FLUID. TECHNICAL SERVICES (TS) SUGGESTED A SHOCK TO MEASURE ACTUAL IMPEDANCE AND DEFIBRILLATION THRESHOLD (DFT) TEST TO CONFIRM ABILITY TO CONVERT VENTRICULAR FIBRILLATION (VF). A SHOCK WAS DELIVERED, AND THE SHOCK LEAD IMPEDANCES WERE STILL LOW BUT WITHIN NORMAL LIMITS. THE PLAN IS TO PERFORM DFT AT A LATER TIME. THIS ELECTRODE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669440 EMBLEM S-ICD ELECTRODE LWS BOSTON SCIENTIFIC CORPORATION 3501 241115 00802526599200

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R