BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1852928 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15521
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    May 17, 2010
    Report Date
    July 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE INITIAL ALLEGATION OF HIGH PACING IMPEDANCE VALUES WAS NOT CONFIRMED BY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED AN INCREASE IN RIGHT VENTRICULAR (RV) PACING IMPEDANCE FROM 758 OHMS TO 1888 OHMS OVER THE PAST SEVERAL MONTHS. THE SHOCK IMPEDANCE VALUE WAS NOTED AS BEING 48 OHMS, THERE WAS ONE NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODE, AND THE THRESHOLD INCREASED FROM 1.6 V TO 2.0 V. THIS PATIENT IS GOING TO VISIT HIS/HER IMPLANT HOSPITAL IN THE NEAR FUTURE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THE RV PACING IMPEDANCE VALUE WAS MEASURED AS 2834 OHMS. THE PHYSICIAN ELECTED TO EXPLANT THIS ICD ALONG WITH THE REST OF THE IMPLANTED SYSTEM DUE TO THE POSSIBILITY OF INFECTION. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1871

    Patients

    Seq Age Sex Outcome Treatment
    1 4472| 1871| 0174