BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1863730 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16333
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 20, 2010
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED AND IS UNDERGOING DETAILED LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    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. ALL LOW VOLTAGE POWER SUPPLY MEASUREMENTS WERE CURRENTLY WITHIN AN APPROPRIATE RANGE; HOWEVER, FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE Q3 2010 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS EARLIER THAN EXPECTED. THE MONITORING VOLTAGE WAS 2.44V WITH A CHARGE TIME OF 14.1 SECONDS. THE DEVICE WAS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW (SRW) ADVISORY THAT WAS ISSUED ON 4/05/2007. TECHNICAL SERVICES DISCUSSED THE SRW CRITERIA OF REACHING 2.65V WITHIN 32 MONTHS, BUT THIS INFORMATION WAS NOT AVAILABLE. THE DEVICE WAS EXPLANTED AND WAS REPLACED WITH ANOTHER BOSTON SCIENTIFIC ICD.

    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 53 YR Required Intervention 0158| T177| E102