BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1871147 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17580
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE'S PROGRAMMED PARAMETER SETTINGS AND THERAPY HISTORY WERE USED TO ESTIMATE EXPECTED BATTERY USE TO DATE, THEN COMPARED TO ACTUAL USE. OUR ANALYSIS SHOWED THIS DEVICE DID NOT MEET LONGEVITY EXPECTATIONS. FINAL ANALYSIS CONCLUDED PREMATURE BATTERY DEPLETION OCCURRED DUE TO A COMPROMISED LOW-VOLTAGE CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION. DESPITE THIS COMPROMISED CAPACITOR, TESTING CONFIRMED THE DEVICE HAD NORMAL PACING, SENSING, AND DEFIBRILLATION THERAPY FUNCTIONS. THIS DEVICE IS INCLUDED IN THE MAY 12, 2006 ADVISORY ISSUED BY GUIDANT (NOW BOSTON SCIENTIFIC CRM) REGARDING PREMATURE BATTERY DEPLETION POTENTIAL IN A SMALL SUBSET OF ICD AND CRT-D DEVICES DUE TO A FAILURE OF A CAPACITOR FROM A SINGLE LOT. THIS ISSUE IS DISCUSSED IN THE Q3 2010 VERSION OF OUR PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT REPORTED HEARING BEEP TONES EMITTED FROM THIS DEVICE. THE DEVICE WAS SUBSEQUENTLY REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI) DECLARATION, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR 0185| T177