BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2041700 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01067
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    May 3, 2011
    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

    AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, OR SHOULD THIS DEVICE GET RETURNED THIS REPORT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    TWO MONTHS LATER THE DEVICE WAS EXPLANTED AND REPLACED. SHOULD THIS DEVICE GET RETURNED, IT WILL BE ANALYZED AND AT TIME, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, IT WAS NOTED THIS DEVICE REACHED THE REPLACEMENT INDICATOR WHILE IMPLANTED. THE DEVICE PASSED LABELED LONGEVITY REQUIREMENTS. TECHNICIANS NOTED THIS DEVICE WILL EMIT BEEPING TONES WHEN THE DEVICE REACHES ERI WHEN THE FEATURE IS TURNED ON. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THIS DEVICE OPERATED APPROPRIATELY ACCORDING TO IT'S PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS BOSTON SCIENTIFIC SALES REPRESENTATIVE CALLED TO REPORT TONES THAT WERE EMITTED FROM DEVICE. ONE WEEK LATER NEW INFORMATION INDICATES THIS DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO AN EXTENDED CHARGE TIME OF 20.5 SECONDS. TECHNICAL SERVICES DISCUSSED THE EXTENDED CHARGE TIME LIMIT, WHICH THIS DEVICE HAS EXCEEDED AND RECOMMENDED A DEVICE REPLACEMENT WITHIN 90 DAYS AFTER THE DATE ERI WAS REACHED. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT ADVISORY.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 4087| 1850| 0154| T125