BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1952253 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23603
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    March 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1620-09 TO Z-1621-09
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. 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

    A REQUEST HAS BEEN MADE FOR THE DEVICE TO BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) BY CHARGE TIME AFTER THREE YEARS. CURRENT MONITORING VOLTAGE WAS 2.51 V AND CHARGE TIME WAS 23.3 SECONDS. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THIS DEVICE IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY. THIS ADVISORY WAS ORIGINALLY COMMUNICATED (B)(6), 2007. THE DEVICE WAS EXPLANTED AND ANOTHER BOSTON SCIENTIFIC DEVICE WAS SUCCESSFULLY IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention E102| T175| 1762| 0125| 1790