BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 6074571 · Received November 2, 2016

    Report

    Report Number
    2124215-2016-12404
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    November 4, 2015
    Report Date
    July 1, 2016
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    UDI-DI
    00802526575600
    PMA / PMN Number
    P110042/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE DATE FOR THIS ELECTRODE WAS MAY 11, 2015. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY ON (B)(6) 2015. THE DEVICE AND ELECTRODE WAS REPLACED WITH A TRANSVENOUS SYSTEM. THE SYSTEM WAS UNABLE TO TERMINATE THE INDUCED ARRHYTHMIA DURING MULTIPLE DEVICE-BASED TESTING. INSTEAD OF REPOSITIONING THE ELECTRODE, THE PATIENT ELECTED TO HAVE THE S-ICD SYSTEM EXPLANTED AND REPLACED WITH A TRANSVENOUS SYSTEM. ACCORDING TO THE LOCAL REPRESENTATIVE THERE WAS NO ALLEGATIONS OF SYSTEM MALFUNCTIONS. BOSTON SCIENTIFIC RECEIVED INFORMATION IN EARLY-JULY 2016 THAT CHEST X-RAY IN EARLY-(B)(6) 2015 CONFIRMED MIGRATION FROM THE BASELINE POSITION. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE ELECTRODE WAS PERFORMED. RESISTANCE TESTS WERE COMPLETED TO ASSESS ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY AND ELECTRODE BODY FOUND NO ANOMALIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY ELECTRODE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). THE LOCAL REPRESENTATIVE REPORTED THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR A SCHEDULED IMPLANT PROCEDURE. THE PHYSICIAN WAS EXPERIENCING DIFFICULTIES INDUCING THE PATIENT INTO AN ARRHYTHMIA DURING DEVICE-BASED TESTING. TS DISCUSSED THE REASONS FOR INDUCTION DIFFICULTIES INCLUDING PATIENT MEDICATION, ANESTHESIA, OR SYSTEM PLACEMENT. THE LOCAL REPRESENTATIVE WAS INFORMED THAT THE PHYSICIAN COULD TRY EXTERNAL DEFIBRILLATION, TWO SHORT BURSTS, OR INDUCTION THROUGH A SEPARATELY INSERTED EP CATHETER. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TS AGAIN TO REPORT THAT INDUCTION TESTING WAS COMPLETED FOLLOWING DELIVERY OF TWO SHORT BURSTS (STAGGERED 50 HZ). THE DEVICE SENSED THE INDUCED ARRHYTHMIA WHICH WAS SUCCESSFULLY TERMINATED FOLLOWING DELIVERY OF A 65 JOULE SHOCK. BECAUSE THE TERMINATION OF THE ARRHYTHMIA WAS CLASSIFIED AS A TYPE II BREAK, THE PHYSICIAN ELECTED TO PERFORM ADDITIONAL DFT TESTS. BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A CLINICAL REPORT THAT THIS PATIENT FAILED SUBSEQUENT DFT TESTING (FAILURE TO TERMINATE INDUCED ARRHYTHMIA ON 5 ATTEMPTS) DESPITE DEVICE REPROGRAMMING (REVERSE POLARITY) AND REPOSITIONING OF THE DEVICE MORE POSTERIOR AND SUPERIOR. A DIAGNOSTIC CHEST XRAY WAS TAKEN ON (B)(6) 2015 WHICH IDENTIFIED A SINGLE LEAD SUBCUTANEOUS LEFT-SIDED ICD IS SEEN WITH THE TIP IN THE ANTERIOR CHEST WALLS. NO PULMONARY VASCULAR CONGESTION. LEFT BASILAR ATELECTASIS, MILD. THERE ARE NO PNEUMOTHORACES OR EFFUSIONS. THE PATIENT HAS BEEN SCHEDULED FOR FOLLOW-UP DFT TESTING IN TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722792 S-ICD SYSTEM IMPLANTABLE LEAD LWS EXTERNAL MANUFACTURER 3401 00802526575600

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| R 3401| A209