BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1945604 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19934
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2010
    Report Date
    June 24, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO HISTORICAL BATTERY MONITORING VOLTAGE DATA WAS PROVIDED. TECHNICAL SERVICES ADVISED THAT THE DEVICE FOLLOW-UP INTENSIFY TO MONTHLY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE AND RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY EIGHT MONTHS LATER THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A HEALTHCARE PROFESSIONAL QUESTIONED THE ADVISORY STATUS OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THIS DEVICE IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY. THIS ADVISORY WAS ORIGINALLY COMMUNICATED (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR T165| 0185| 4479