BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1874833 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17760
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 6, 2010
    Report Date
    October 12, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS ISSUE IS DISCUSSED IN THE Q3 2010 PRODUCT PERFORMANCE REPORT.

    Additional Manufacturer Narrative · 1

    THE ICD WAS SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE THE DEVICE HAS BEEN RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER BEING IMPLANTED 43 MONTHS. ERI WAS REACHED DUE TO AN EXTENDED CHARGE TIME OF 21.5 SECONDS. THERE WAS A CONCERN THAT THE BATTERY HAD DEPLETED EARLIER THAN EXPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE ICD WAS RETURNED.

    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 Required Intervention