BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1871487 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17213
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 8, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DETAILED ANALYSIS, THIS EVENT WILL BE UPDATED AND FILED.

    Additional Manufacturer Narrative · 1

    DETAILED LABORATORY ANALYSIS ATTEMPTED TO DETERMINE IF THE DEVICE'S RATE OF BATTERY DEPLETION WAS WITHIN NORMAL LIMITS, OUR TECHNICIANS COMPARED THE OBSERVED RATE OF BATTERY USAGE TO THE EXPECTED RATE OF BATTERY USAGE. THE RESULTS SHOWED THAT THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. LABORATORY TECHNICIANS AND ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, THE ERI TO EOL TIME PERIOD WAS SHORTENED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED WITH NO ALLEGATIONS. UPON INITIAL LABORATORY TESTING REVEALED THAT A POSSIBLE OUT OF SPECIFICATION CONDITION WAS PRESENT. DETAILED ANALYSIS WILL BE PERFORMED TO DETERMINE THE ROOT CAUSE OF THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1871

    Patients

    Seq Age Sex Outcome Treatment
    1