BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD ELECTRODE

    MDR report key: 15636465 · Received October 19, 2022

    Report

    Report Number
    2124215-2022-42521
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    September 11, 2022
    Report Date
    November 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH A SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED AN INAPPROPRIATE SHOCK WHILE SLEEPING DUE TO OVER-SENSED NOISY SIGNALS. THE PATIENT WAS BROUGHT INTO CLINIC WHERE PROVOCATIVE MANEUVERS WERE PERFORMED, BUT THE NOISE WAS UNABLE TO BE REPRODUCED. THE DEVICE DATA WAS FORWARDED TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR REVIEW AND IT WAS RECOMMENDED TO PERFORM DIAGNOSTIC IMAGING TO ASSESS THE S-ICD SYSTEM INTEGRITY AND POSITION. BECAUSE THE NOISE WAS UNABLE TO BE REPRODUCED, TS INDICATED THAT IT MAY BE RELATED TO SENSE B NODE SENSING CIRCUIT ISSUE. THE CLINIC PROGRAMMED OFF THERAPY FROM THE DEVICE TO PREVENT FURTHER INAPPROPRIATE SHOCKS. AT THIS TIME, THE SYSTEM REMAINS IMPLANTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH A SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED AN INAPPROPRIATE SHOCK WHILE SLEEPING DUE TO OVER-SENSED NOISY SIGNALS. THE PATIENT WAS BROUGHT INTO CLINIC WHERE PROVOCATIVE MANEUVERS WERE PERFORMED, BUT THE NOISE WAS UNABLE TO BE REPRODUCED. THE DEVICE DATA WAS FORWARDED TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR REVIEW AND IT WAS RECOMMENDED TO PERFORM DIAGNOSTIC IMAGING TO ASSESS THE S-ICD SYSTEM INTEGRITY AND POSITION. BECAUSE THE NOISE WAS UNABLE TO BE REPRODUCED, TS INDICATED THAT IT MAY BE RELATED TO SENSE B NODE SENSING CIRCUIT ISSUE. THE CLINIC PROGRAMMED OFF THERAPY FROM THE DEVICE TO PREVENT FURTHER INAPPROPRIATE SHOCKS. DIAGNOSTIC IMAGING WAS RECOMMENDED, BUT NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT IS CONTINUING WITH NORMAL MONITORING AND THERAPY REMAINS PROGRAMMED OFF. AT THIS TIME, THE SYSTEM REMAINS IMPLANTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2882666 EMBLEM S-ICD ELECTRODE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 3501 178977

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown