BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1781222 · Received August 3, 2010

    Report

    Report Number
    2124215-2010-15320
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    February 27, 2010
    Report Date
    June 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY ANALYZED. 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 Q2 2010 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONTACTED OUR INTERNAL TECHNICAL SERVICE DEPARTMENT AND REPORTED HEARING TONES BEING EMITTED FROM THE DEVICE. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REPRESENTATIVE DISCUSSED THAT OUR DEVICE WILL EMIT 16 TONES EVERY SIX HOURS WHEN IT REACHES THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND THAT THE PATIENT SHOULD HAVE THE DEVICE CHECKED. THE PATIENT ALSO REPORTED THAT HE WAS FEELING FINE AND NO ADVERSE EFFECTS WERE REPORTED. AT A LATER DATE, THIS ICD WAS SUCCESSFULLY EXPLANTED AND RETURNED FOR DISPOSAL. THERE WERE NO ALLEGATIONS AGAINST THE LONGEVITY OR FUNCTIONALITY OF THIS DEVICE.

    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 79 YR T175| 0185