BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 15636471 · Received October 19, 2022

    Report

    Report Number
    2124215-2022-42522
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    September 11, 2022
    Report Date
    June 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    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.

    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. SUBSEQUENTLY, THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE S-ICD DEVICE TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE S-ICD WAS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED. SHOULD THE PRODUCT BE RETURNED IN THE FUTURE, THIS RECORD WILL BE UPDATED WITH ANALYSIS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2882672 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 126293 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R