BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3920024 · Received July 8, 2014

    Report

    Report Number
    2124215-2014-13649
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 19, 2014
    Report Date
    September 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    (B)(4). DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS RECENTLY SEEN FOLLOWING 11 INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION. THE DEVICE NEVER DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) HOWEVER AFTER THE BOSTON SCIENTIFIC SALES REPRESENTATIVE PERFORMED A CAP REFORM, THE DEVICE DECLARED END OF LIFE (EOL) AND DISPLAYED A CODE INDICATING A LONG CHARGE TIME. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED WITHOUT INCIDENT. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396234 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R T165| 0184| 4086