BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1852626 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14230
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    February 3, 2007
    Report Date
    July 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTROCARDIOGRAM, NUCLEAR, AND VITAL SIGNS WERE NORMAL AFTER THE EVENT. FLUIDS WERE PUSHED AND ENCOURAGED THE PATIENT TO SIT WHEN FEELING DIZZY. AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE WITHOUT ADDITIONAL COMPLICATION. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. THE DEVICE EVENTUALLY WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS. INITIAL ANALYSIS REVEALED A DEVICE ANOMALY. DETAILED ANALYSIS IS PENDING.

    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 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A SYNCOPAL EVENT WHILE VISITING A SICK FAMILY MEMBER IN THE HOSPITAL. THERE WERE NO ALLEGATIONS TOWARDS DEVICE INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4086| 0180| T167