BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1951391 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22850
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    January 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Removal / Correction Number
    Z-0047-08 TO Z-0053-08
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED. THE PATIENT FAILED AT 21 JOULES WITH A REPORTED GREATER THAN 125 OHMS SHOCKING IMPEDANCE MEASUREMENTS. DFTS WERE SUCCESSFUL AT 31 JOULES WITH A 121 SHOCKING IMPEDANCE MEASUREMENT. A CHEST X-RAY WAS PERFORMED WHICH VERIFIED THE TERMINAL PINS WERE FULLY INSERTED THROUGH THE BACK OF THE DEVICE HEADER. THERE WERE NO OBVIOUS ANOMALIES NOTED WITH THE LEAD BODY. THE SALES REPRESENTATIVE PLANNED TO DISCUSS THE OPTION TO REVISE THE LEAD WITH THE PHYSICIAN.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION RECEIVED INDICATED A LEAD REVISION PROCEDURE PLANNED TO TAKE PLACE. THE DEVICE ALSO PLANNED TO BE REPLACED TO ACCOMMODATE THE 31 JOULE DFT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD REMAINS IN SERVICE WITH THE NEW DEVICE. ALL MEASUREMENTS APPEARED TO BE WITHIN NORMAL RANGE. 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 WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON INTERROGATION THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD DISPLAYED HIGH OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS IN THE CLINICAL EVENTS. THE CURRENT SHOCKING IMPEDANCE WAS 96 OHMS. IT APPEARED THAT THE IMPEDANCE HAD STARTED TRENDING UPWARD APPROXIMATELY FOUR MONTHS AGO. THERE HAS BEEN NO THERAPY RECENTLY DELIVERED. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED AT IMPLANT IN WHICH A 14 JOULE SHOCK WAS DELIVERED AND REPORTED A 37 OHMS IMPEDANCE MEASUREMENT. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED TESTING THE INTEGRITY OF THE SYSTEM TO VERIFY THE SYSTEM CAN EFFECTIVELY CONVERT THE PATIENT.

    Description of Event or Problem · 1

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    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention T175| 0184