BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2171149 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09912
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 27, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THIS DEVICE SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS INVESTIGATION WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, 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. BENCH TESTING VERIFIED THAT ALL MANUAL LEAD IMPEDANCE MEASUREMENTS WERE WITHIN THEIR NORMAL RANGE AND ALSO VERIFIED THAT DEVICE WAS CAPABLE OF DELIVERING BOTH BRADY AND TACHY THERAPIES AS PROGRAMMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention T135| 0185