BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2173811 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11255
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    December 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS DEVICE REMAINS ACTIVELY IN SERVICE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THIS MEDICAL DEVICE HAS BEEN RETURNED TO BOSTON SCIENTIFIC BUT ANALYSIS REMAINS INCONCLUSIVE TO DATE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. THE INVESTIGATION REMAINS OPEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, LABORATORY TECHNICIANS UTILIZED AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILATOR (ICD), WHICH IS PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY AND INITIALLY COMMUNICATED ON (B)(6) 2007, WAS PLANNED FOR CHANGEOUT DUE TO CONCERN FOR ABNORMAL BATTERY LONGEVITY. THE MONITORING VOLTAGE MEASUREMENT WAS NOTED AT 2.54 VOLTS. THE CHARGE TIME MEASUREMENT WAS NOT NOTED IN THE INITIAL EVENTED INFORMATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    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
    1 318 MO T165| 0184| 4479