BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DS VR

    MDR report key: 1043355 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33296
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 8, 2008
    Report Date
    June 30, 2010
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED AN INCREASED CHARGE TIME (CT) OF 18.7 SECONDS, WHICH WAS .2 SECONDS FROM REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). A TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY AND THAT ERI MIGHT BE REACHED DURING THE NEXT AUTOMATIC CAPACITOR REFORMATION. THEY DISCUSSED DEMONSTRATING BEEPING TONES FOR THE PATIENT. THE DEVICE WAS LATER EXPLANTED AND RETURNED FOR ANALYSIS. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    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 0157/119242 WAS IMPLANTED 24-MAR-2004| THE DEVICE 6481 049623 WAS USED DURING THE EVENT.