BEUDAMED
    FDA Adverse Event Death Summary report: N

    S-ICD SYSTEM

    MDR report key: 5148396 · Received October 14, 2015

    Report

    Report Number
    2124215-2015-13345
    Event Type
    Death
    Date Received
    October 14, 2015
    Date of Event
    September 2, 2015
    Report Date
    October 20, 2015
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    PMA / PMN Number
    P110042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT ONLY THE PROXIMAL SEGMENT WAS RETURNED; SEVERED APPROXIMATELY 28 MM FROM THE TERMINAL PIN. THERE WAS ONE SETSCREW MARK ON THE TERMINAL PIN IN THE CORRECT LOCATION. RESISTANCE TESTING WAS PERFORMED ON THE ELECTRODE SEGMENT TO ASSESS THE ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS WITH THE SMALL PORTION OF THE ELECTRODE THAT WAS RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS. DATE OF MANUFACTURE: FEBRUARY 10, 2015.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM PASSED AWAY. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN. THERE WERE ALSO NO ALLEGATIONS AGAINST THE FUNCTIONALITY OF THE DEVICE OR THAT IS CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. WHEN THE S-ICD WAS IMPLANTED, THE SCREENING WAS ACCEPTABLE IN BOTH THE DII AND DIII LEADS. SENSING WAS FINE IN THE PRIMARY VECTOR AND DEFIBRILLATION THRESHOLD (DFT) TEST WAS SUCCESSFUL WITH THE TIME TO THERAPY DELIVERY BEING 15 SECONDS. THE SHOCK IMPEDANCE MEASUREMENT WAS 51 OHMS. A MEMORY DOWNLOAD WAS PERFORMED AT A LATER DATE AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR EVALUATION. A TS CONSULTANT DISCUSSED THAT THE SHOCK IMPEDANCE MEASUREMENTS HAD GRADUALLY DECREASED TO 0 OHMS SEVERAL WEEKS POST-IMPLANT, INDICATING THAT THE ELECTRODE WAS IN VERY CLOSE PROXIMITY TO THE DEVICE AND MAY HAVE SHORTED TO THE DEVICE. IN ADDITION, THERE WAS AN EPISODE RECORDED FIVE DAYS PRIOR TO THE DAY OF THE PATIENT'S DEATH THAT SHOWED VERY SMALL AMPLITUDES, MOST LIKELY DUE TO MINIMAL DISTANCE BETWEEN THE ELECTRODE AND THE DEVICE. THE S-ICD WAS EXPLANTED AND WAS RETURNED. A PORTION OF THE ELECTRODE WAS RETURNED AND IS CURRENTLY UNDERGOING LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680364 S-ICD SYSTEM IMPLANTABLE LEAD LWS EXTERNAL MANUFACTURER 3401

    Patients

    Seq Age Sex Outcome Treatment
    1 Death A209