BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DS VR

    MDR report key: 1041950 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34689
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 21, 2008
    Report Date
    June 4, 2010
    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

    A SAVE TO DISK WAS COMPLETED AND RETURNED FOR ANALYSIS. ANALYSIS OF THE STORED INFORMATION INDICATED THIS ICD DOES APPEAR TO BE DEPLETING PREMATURELY. THE INFORMATION PROVIDED INDICATES THIS ICD REMAINS IMPLANTED. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY 21 MONTHS LATER INDICATED THIS DEVICE HAD A MONITORING VOLTAGE OF 2.52 VOLTS. THERE WAS NO INDICATION THAT ELECTIVE REPLACEMENT INDICATOR (ERI) HAD YET BEEN DECLARED. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT RECOMMENDED REPLACING THE DEVICE WITHIN ONE MONTH OF DECLARING ERI. APPROXIMATELY FOUR MONTHS LATER THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS. 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 A COMPROMISED LOW-VOLTAGE CAPACITOR, 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 (ICD), WHICH HAS BEEN IMPLANTED FOR 33 MONTHS, EXHIBITED A DECLINE IN MONITORING VOLTAGE IN A SPAN OF 3 MONTHS THAT WAS FELT TO BE TOO FAST. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION BUT HAS NOT YET REACHED A MONITORING VOLTAGE OF 2.65 VOLTS.

    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 64 YR Other THE DEVICE 0184/114334 WAS IMPLANTED 15-JUN-2005