BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2780991 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13347
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    June 12, 2009
    Report Date
    September 27, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1620-09 TO Z-1621-09
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE HAD A COMPROMISED LOW-VOLTAGE CAPACITOR THAT DID NOT MEET DESIGN SPECIFICATION. DESPITE THIS COMPROMISED CAPACITOR, CURRENT LEAKAGE WAS NOT SUFFICIENT TO ADVERSELY IMPACT DEVICE LONGEVITY. NORMAL PACING, SENSING, AND DEFIBRILLATION THERAPY FUNCTIONS WERE VERIFIED DURING TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A MONITORING VOLTAGE OF 2.65 VOLTS AFTER 36 MONTHS OF IMPLANT. A SAVE TO DISK WAS RECEIVED FOR ANALYSIS WHICH FOUND THE DEVICE HAD REACHED MIDDLE OF LIFE 2 DUE TO CHARGE TIME. THE DEVICE WAS EXPLANTED APPROXIMATELY THREE YEARS LATER DUE TO NORMAL BATTERY DEPLETION. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR T177| 0185