BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD ELECTRODE

    MDR report key: 17733429 · Received September 12, 2023

    Report

    Report Number
    2124215-2023-49843
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    August 12, 2023
    Report Date
    March 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION OF THIS ELECTRODE NOTED AN ARC MARK ON THE SHOCKING COIL, LOCATED APPROXIMATELY 380 MM FROM THE TERMINAL END. ARCING DAMAGE LIKE THAT SEEN ON THIS ELECTRODE IS CONSISTENT WITH AN ATTEMPT TO DELIVER THERAPY WHEN IN CLOSE PROXIMITY TO THE DEVICE CAN, WHICH MAY CAUSE INTERNAL DAMAGE TO THE CIRCUITRY. AS THE FIELD WAS ABLE TO CONFIRM ELECTRODE DISLODGEMENT VIA DIAGNOSTIC IMAGING, EVIDENCE SUGGESTS THE CLOSE PROXIMITY OF THE DEVICE AND ELECTRODE OCCURRED FOLLOWING THIS DISLODGEMENT. BASED ON INSPECTION AND ANALYSIS OF THIS ELECTRODE, EVIDENCE INDICATES THAT THE ARCING DAMAGE OCCURRED WHILE ATTEMPTING TO DELIVERY SHOCK THERAPY, WHILE THE ELECTRODE WAS IN CLOSE PROXIMITY TO THE DEVICE. THIS ARCING DAMAGE RESULTED IN THE CLINICAL OBSERVATIONS OF OVER-SENSING, INAPPROPRIATE SHOCK THERAPY, AND LOW, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH A SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED AN INAPPROPRIATE SHOCK DUE TO OVER-SENSED NOISY SIGNALS. THE IMPEDANCE OF THE DELIVERED SHOCK WAS FOUND TO BE 1 OHM AND A CHARGE TIME (CT) ERROR CODE WAS DECLARED. THE PATIENT WAS HOSPITALIZED WHERE DIAGNOSTIC IMAGING REVEALED THE S-ICD ELECTRODE HAD DISLODGED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND CONFIRMED THE CLINICAL OBSERVATIONS REQUIRED AN EMERGENT SYSTEM REPLACEMENT. S-ICD SHOCK THERAPY WAS PROGRAMMED OFF AND A REVISION PROCEDURE WAS SCHEDULED. THE PHYSICIAN SUBSEQUENTLY EXPLANTED AND REPLACED THE S-ICD SYSTEM TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED SYSTEM IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH A SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED AN INAPPROPRIATE SHOCK DUE TO OVER-SENSED NOISY SIGNALS. THE IMPEDANCE OF THE DELIVERED SHOCK WAS FOUND TO BE 1 OHM AND A CHARGE TIME (CT) ERROR CODE WAS DECLARED. THE PATIENT WAS HOSPITALIZED WHERE DIAGNOSTIC IMAGING REVEALED THE S-ICD ELECTRODE HAD DISLODGED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND CONFIRMED THE CLINICAL OBSERVATIONS REQUIRED AN EMERGENT SYSTEM REPLACEMENT. S-ICD SHOCK THERAPY WAS PROGRAMMED OFF AND A REVISION PROCEDURE WAS SCHEDULED. THE PHYSICIAN SUBSEQUENTLY EXPLANTED AND REPLACED THE S-ICD SYSTEM TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED SYSTEM IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH A SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED AN INAPPROPRIATE SHOCK DUE TO OVER-SENSED NOISY SIGNALS. THE IMPEDANCE OF THE DELIVERED SHOCK WAS FOUND TO BE 1 OHM AND A CHARGE TIME (CT) ERROR CODE WAS DECLARED. THE PATIENT WAS HOSPITALIZED WHERE DIAGNOSTIC IMAGING REVEALED THE S-ICD ELECTRODE HAD DISLODGED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND CONFIRMED THE CLINICAL OBSERVATIONS REQUIRED AN EMERGENT SYSTEM REPLACEMENT. S-ICD SHOCK THERAPY WAS PROGRAMMED OFF AND A REVISION PROCEDURE WAS SCHEDULED. THE PHYSICIAN SUBSEQUENTLY EXPLANTED AND REPLACED THE S-ICD SYSTEM TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED SYSTEM WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861836 EMBLEM S-ICD ELECTRODE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 3501 231751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R