BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1871548 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17286
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO BOSTON SCIENTIFIC CRM'S (B)(4) LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THE DEVICE DECLARED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. ADDITIONAL LAB ANALYSIS AND TESTING SHOWED ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF DEVICE INTERNAL BATTERY IMPEDANCE. THE EOL (END OF LIFE) INDICATOR WAS NOT DECLARED WHILE THE DEVICE WAS IN SERVICE. TESTING CONFIRMED ALL DEVICE THERAPIES WERE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE IS PENDING.

    Description of Event or Problem · 1

    THE DEVICE SUBSEQUENTLY WAS EXPLANTED AND REPLACED THREE WEEKS LATER WITH NO ADVERSE PATIENT EFFECTS. THE DEVICE'S REPORTING STATUS IS CHANGED TO SERIOUS INJURY FROM MALFUNCTION DUE TO EXPLANT WITH EARLY ERI PREVIOUSLY SUSPECTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS DEVICE DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI) ASSOCIATED WITH A MIDDLE OF LIFE 2 BATTERY MEASUREMENT AND AN EXTENDED CHARGE TIME THAT EXCEEDED SPECIFICATIONS. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION COMMUNICATED 11/27/2007. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T127

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR (B)(4)| (B)(4)| (B)(4)