BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DS VR

    MDR report key: 1254092 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40893
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 24, 2008
    Report Date
    January 27, 2011
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES ADVISED THAT THE DEVICE FOLLOW-UP INTENSIFY TO MONTHLY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE AND RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. THE DEVICE WAS EXPLANTED MORE THAN TWO YEARS LATER, AND WAS REPLACED WITH ANOTHER BOSTON SCIENTIFIC ICD. THERE WAS STILL SOME CONCERN THAT THE DEVICE DEPLETED FASTER THAN EXPECTED. THE EXPLANTED DEVICE WILL BE RETURNED FOR LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH WAS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY, ORIGINALLY COMMUNICATED (B)(6), 2007, HAD A MONITORING BATTERY VOLTAGE OF 2.65 V AFTER 24 MONTHS OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2006| THE DEVICE 0148/147662 WAS IMPLANTED 16-MAY-2006