BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 7469404 · Received April 27, 2018

    Report

    Report Number
    2124215-2018-07725
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    March 20, 2018
    Report Date
    March 20, 2018
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE JOURNAL AUTHOR REPORTED CASES IN WHICH DFT TESTING WAS NOT PERFORMED DURING THE IMPLANT PROCEDURE. DFT TESTING WAS NOT PERFORMED DUE TO AN INABILITY TO INDUCED A SUSTAINED VENTRICULAR FIBRILLATION ARRHYTHMIA (3-PATIENTS), KNOWN LEFT VENTRICULAR THROMBUS (1-PATIENT), THE PRESENCE OF ATRIAL FIBRILLATION WITH INADEQUATE ANTICOAGULATION (1-PATIENT), AND THE PRESENCE OF HEMODYNAMICALLY INSTABILITY DURING IMPLANTATION (1-PATIENT). IN THE ONE CASE OF HEMODYNAMIC INSTABILITY, PROFOUND BRADYCARDIA AND HYPOTENSION DEVELOPED DURING DEVICE IMPLANTATION REQUIRING CHEST COMPRESSIONS TO BE PERFORMED BRIEFLY, WITH PROMPT RESOLUTION ULTIMATELY ACHIEVED. ADVERSE EVENTS THAT OCCURRED WITH DFT TESTING INCLUDED 2- PATIENTS THAT EXPERIENCED BRADYCARDIA AND HYPOTENSION AT THE END OF DFT TESTING, BOTH REQUIRING SHORT-TERM PHARMACOLOGIC INTERVENTION AND MONITORING IN THE INTENSIVE CARE UNIT POSTPROCEDURE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. DO, K., P. M. CHANG, ET AL. ( 2017). "PREDICTORS OF ELEVATED DEFIBRILLATION THRESHOLD WITH THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR." J INNOVATIONS CARDIAC RHYTHM MANAG 8( 12): 2920?2929.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A JOURNAL ARTICLE TITLED "PREDICTORS OF ELEVATED DEFIBRILLATION THRESHOLD WITH SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICES. THE OBJECTIVE OF THIS STUDY WAS TO DETERMINE THE FACTORS ASSOCIATED WITH ELEVATED DEFIBRILLATION THRESHOLD TESTS (DFTS) IN PATIENTS UNDERGOING S-ICD IMPLANTATION. A RETROSPECTIVE CROSS-SECTIONAL ANALYSIS OF ALL PATIENTS UNDERGOING S-ICD IMPLANTATION BETWEEN 2013 AND 2016 WHO UNDERWENT STEP-DOWN DFT TESTING WAS PERFORMED AT THE JOURNAL AUTHOR'S INSTITUTION. IN TOTAL, 56 PATIENTS UNDERWENT S-ICD IMPLANTATION IN THE STUDY PERIOD. FULL DFT TESTS WERE PERFORMED IN 31 OF THE 56 PATIENTS WITH AN AVERAGE DFT OF 49.3 JOULES. THE DFT WAS GREATER THAN 65 JOULES IN FIVE OF THE 31 PATIENTS. A HIGH DFT WAS ASSOCIATED WITH INCREASED BMI AND EITHER INCREASED SEPTAL OR POSTERIOR WALL THICKNESS. PATIENTS WITH HIGH DFT ALSO HAD HIGHER FAILED SHOCK IMPEDANCE VALUES. RENAL FAILURE DID NOT APPEAR TO AFFECT DFT. BODY MASS INDEX (BMI), BODY SURFACE AREA (BSA) AND SEPTAL AND POSTERIOR LEFT VENTRICULAR WALL THICKNESS PREDICTED ELEVATED DFT ON UNIVARIATE ANALYSIS, ALTHOUGH FINDINGS WERE NOT SIGNIFICANT WITH MULTIVARIATE ANALYSIS DUE TO SMALL SAMPLE SIZE. SYSTEMATIC STEP-DOWN DEFIBRILLATION TESTING IN A HETEROGENEOUS PATIENT POPULATION RECEIVING THE S-ICD, INCLUDING MORBIDLY OBESE PATIENTS AND THOSE WITH END STAGE RENAL DISEASE (ESRD), SHOWS A HIGHER INCIDENCE OF INADEQUATE DFT SAFETY MARGIN WITH THE S-ICD THAN ORIGINALLY REPORTED IN EARLY DEVICE EXPERIENCE. MORBID OBESITY WITH BMI GREATER THAN OR EQUAL TO 35 KG/M2, HIGHER BSA, AND INCREASED SEPTAL AND POSTERIOR WALL THICKNESS MAY PREDICT HIGHER DFT AND AN INCREASED RISK OF DEFIBRILLATION FAILURE WITH THE S-ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312959 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 3401| A219