BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 946332 · Received November 8, 2007

    Report

    Report Number
    2124215-2007-27033
    Event Type
    Injury
    Date Received
    November 8, 2007
    Date of Event
    August 9, 2007
    Report Date
    August 29, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION STATED THAT THIS ICD WAS REPLACED DUE TO THE INCREASED IMPEDANCES. ALL LEAD MEASUREMENTS WERE REPORTED WITHIN NORMAL RANGE AFTER EXPLANT. AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS RV LEAD REMAINS IN SERVICE WITHOUT ADDITIONAL COMPLICATION AND THE T175 HAS NOT BEEN RETURNED. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. THIS 1830 WAS FOUND TO BE AT MIDDLE OF LIFE 2 (MOL) UPON RETURN AND NO ERI TIMESTAMP HAD BEEN RECORDED. A REVIEW OF THE DAILY MEASUREMENTS CONFIRMED THAT THE VENTRICULAR LEAD IMPEDANCE MEASUREMENTS HAD BEEN FLUCTUATING SINCE (B)(6) 2007. THE RANGE RECORDED IS FROM 710-1659 OHMS. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED TESTS WHICH CONFIRMED THE PACING, SENSING, IMPEDANCE, HIGH VOLTAGE SHOCKING, AND RECORDING FUNCTIONS. CRITICAL THERAPY WAS CONFIRMED TO BE AVAILABLE. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS. 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 AND SHOWED GOOD LEAD INSERTION DEPTH BY SEAL RING MARKS IN THE RV PORT. 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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD INTERMITTENT RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD PACING IMPEDANCES OF GREATER THAN 2000 OHMS. ADDITIONAL INFORMATION PROVIDED STATED THAT THE PHYSICIAN CHANGED OUT THE DEVICE DUE TO IT BEING AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE PHYSICIAN NOTICED SOME CALCIFIED MATERIAL ON THE LEADS TIP AND BELIEVED IT WAS CAUSING THE INTERMITTENT READINGS. THIS LEAD WAS LEFT IN AND ALL MEASUREMENTS CHECKED OUT OKAY AT IMPLANT AND POST IMPLANT. FURTHERMORE, THIS RV LEAD HAD CONTINUED HIGH PACING IMPEDANCE MEASUREMENTS, INCREASED PACING THRESHOLDS, DECREASED R-WAVES. MEASUREMENTS REVERT BACK TO NORMAL WITH POCKET MANIPULATION. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED POSSIBLE CONNECTION OR LEAD FRACTURE ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R THE DEVICE (B)(4) WAS IMPLANTED:| THE DEVICE (B)(4) WAS IMPLANTED: