BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 5113233 · Received September 30, 2015

    Report

    Report Number
    2124215-2015-12462
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 24, 2015
    Report Date
    October 8, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE S-ICD WAS PERFORMED. THE MEMORY WAS REVIEWED AND REVEALED THAT THE DEVICE HAD EXPERIENCED A MEMORY CORRUPTION WHICH LED TO A RESET IN ORDER TO SELF-CORRECT THE INCONSISTENCY. THE S-ICD WAS THEN EXPOSED TO A SIMULATED HEART LOAD CONDITION IN THE PRIMARY SENSING VECTOR TO TEST THE SENSING AND DEFIBRILLATION FUNCTIONS. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO OUT OF RANGE MEASUREMENTS OR INTERRUPTIONS IN SHOCK THERAPY OUTPUT. LABORATORY ANALYSIS CONCLUDED THAT THE S-ICD EXPERIENCED A MEMORY INCONSISTENCY DURING INDUCTION TESTING WHICH LED TO A DEVICE RESET. THE RESET DID SELF-CORRECT THE MEMORY AND THE DEVICE IS ABLE TO SENSE AND DELIVER THERAPY. THE CAUSE OF THE MEMORY INCONSISTENCY WAS NOT ABLE TO BE DETERMINED THROUGH LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), INDUCTION TESTING WAS PERFORMED. A VENTRICULAR FIBRILLATION (VF) WAS ABLE TO BE INDUCED AND INITIALLY THE S-ICD WAS SENSING THE ARRHYTHMIA CORRECTLY. WHEN THE S-ICD STARTED TO CHARGE, IT STARTED UNDERSENSING THE VF. AS A RESULT, THE CHARGE WAS ABORTED, AND A SHOCK WAS NOT DELIVERED. EXTERNAL DEFIBRILLATION WAS PROVIDED TO CONVERT THE VF INTO NORMAL SINUS RHYTHM. THE S-ICD WAS REMOVED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    A MEMORY DOWNLOAD WAS PERFORMED AND REVIEWED BY A BOSTON SCIENTIFIC ENGINEER. IT WAS DETERMINED THAT THE DEVICE EXPERIENCED A DEVICE MEMORY INTEGRITY CHECK CONDITION. THE DEVICE MAY HAVE HAD AN UNEXPECTED FIRMWARE CODE POTENTIALLY DUE TO A SINGLE EVENT UPSET (SEU) WHILE THE DEVICE WAS IN SHELF MODE. THIS UNEXPECTED MEMORY CONDITION COULD HAVE CONTRIBUTED TO THE SENSING ANOMALY OBSERVED DURING INDUCTION. BASED ON THE MEMORY ANALYSIS, THE SENSING ANOMALY OCCURRED WHEN THE DEVICE WAS CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645963 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A209

    Patients

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