BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1852715 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14777
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS (NOVEMBER 27, 2007) ADVISORY POPULATION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION VIA A LATITUDE RED ALERT THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED END OF LIFE (EOL) DUE TO AN EXTENDED CHARGE TIME THAT WAS OUT OF THE EXTENDED CHARGE TIME LIMIT FOR THE DEVICE. THE DEVICE WAS EXPLANTED AND HAS BEEN RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THE DEVICE IS A PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY.

    Description of Event or Problem · 1

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    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 80 YR Required Intervention 1763| 0125| T177