BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 17347211 · Received July 18, 2023

    Report

    Report Number
    2124215-2023-37990
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    July 15, 2023
    Report Date
    August 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC. AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. INVESTIGATION OF THE AVAILABLE INFORMATION DETERMINED THIS DEVICE'S DELIVERY OF A SHOCK MAY HAVE CONTRIBUTED TO UNINTENTIONAL INDUCTION OF OR ACCELERATION OF AN ARRHYTHMIA. PLEASE REFER TO THE EVENT DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) RECORDED MULTIPLE APPROPRIATELY TREATED EPISODES. HOWEVER, DURING ONE OF THE EPISODES A SHOCK SEEMED TO ACCELERATE THE PATIENT'S SELF-CONDUCTED VENTRICULAR RHYTHM FROM VENTRICULAR TACHYCARDIA (VT) TO VENTRICULAR FIBRILLATION (VF). THE SHOCK STOPPED THE ARRHYTHMIA. ALL ELECTRICAL PARAMETERS WERE IN RANGE, WITH A SHOCK IMPEDANCE OF 72 OHMS. CLINICAL EVALUATION DEFINED THE EPISODES AS VT OF 210 BEATS PER MINUTE (BPM); THEREFORE, THE SHOCK AND CONDITIONAL ZONES WERE SLIGHTLY DECREASED FROM 210/240 TO 200/230 TO REDUCE THE TIME TO THERAPY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS S-ICD REMAINS IN SERVICE. ADDITIONAL INFORMATION RECEIVED INDICATES THIS S-ICD WAS EXPLANTED ACCORDING TO THE PHYSICIAN'S DECISION BASED ON THE CLINICAL CONDITION OF THE PATIENT. AT THIS TIME, PRODUCT RETURN IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) RECORDED MULTIPLE APPROPRIATELY TREATED EPISODES. HOWEVER, DURING ONE OF THE EPISODES A SHOCK SEEMED TO ACCELERATE THE PATIENT'S SELF-CONDUCTED VENTRICULAR RHYTHM FROM VENTRICULAR TACHYCARDIA (VT) TO VENTRICULAR FIBRILLATION (VF). THE SHOCK STOPPED THE ARRHYTHMIA. ALL ELECTRICAL PARAMETERS WERE IN RANGE, WITH A SHOCK IMPEDANCE OF 72 OHMS. CLINICAL EVALUATION DEFINED THE EPISODES AS VT OF 210 BEATS PER MINUTE (BPM); THEREFORE, THE SHOCK AND CONDITIONAL ZONES WERE SLIGHTLY DECREASED FROM 210/240 TO 200/230 TO REDUCE THE TIME TO THERAPY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS S-ICD REMAINS IN SERVICE. ADDITIONAL INFORMATION RECEIVED INDICATES THIS S-ICD WAS EXPLANTED ACCORDING TO THE PHYSICIAN'S DECISION BASED ON THE CLINICAL CONDITION OF THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) RECORDED MULTIPLE APPROPRIATELY TREATED EPISODES. HOWEVER, DURING ONE OF THE EPISODES A SHOCK SEEMED TO ACCELERATE THE PATIENT'S SELF-CONDUCTED VENTRICULAR RHYTHM FROM VENTRICULAR TACHYCARDIA (VT) TO VENTRICULAR FIBRILLATION (VF). THE SHOCK STOPPED THE ARRHYTHMIA. ALL ELECTRICAL PARAMETERS WERE IN RANGE, WITH A SHOCK IMPEDANCE OF 72 OHMS. CLINICAL EVALUATION DEFINED THE EPISODES AS VT OF 210 BEATS PER MINUTE (BPM); THEREFORE, THE SHOCK AND CONDITIONAL ZONES WERE SLIGHTLY DECREASED FROM 210/240 TO 200/230 TO REDUCE THE TIME TO THERAPY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS S-ICD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766735 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 176435

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown Life Threatening| R| H