BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2910930 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16732
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED WITH PROGRAMMING CHANGES. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED IN VENTRICULAR TACHYCARDIA (VT) ZONE WHICH ACCELERATED THE RATE INTO VENTRICULAR FIBRILLATION (VF) ZONE. SHOCK FOR VF SLOWED THE RATE TO VT-1 ZONE. A SHOCK THERAPY WAS DELIVERED, HOWEVER SLOWED THE ARRHYTHMIA BACK INTO A VT-1 ZONE WHERE THERAPY WAS EXHAUSTED. NO FURTHER THERAPY WAS ABLE TO BE DELIVERED FOR THIS PATIENT UNTIL THE EPISODE ENDED. AS A RESULT, THE RHYTHM ACCELERATION DUE TO ATP DELIVERY RESULTED IN AN UNSUCCESSFUL CONVERSION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. PROGRAMMING CHANGES WERE MADE TO LOWER THE ZONE.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17928 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R 0158| T135| T175