BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1771633 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-14223
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 8, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE HAD TWO COMPROMISED LOW-VOLTAGE CAPACITORS, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THAT WAS IMPLANTED ON (B) (6) 2006 REACHED ELECTIVE REPLACEMENT INDICATOR. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other