BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 VR

    MDR report key: 1116288 · Received August 14, 2008

    Report

    Report Number
    2124215-2008-37835
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    June 26, 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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A MONITORING VOLTAGE OF 2.60. IT WAS NOTED THAT THIS PATIENT HAD BEEN NON-COMPLIANT AND THIS WAS THEIR FIRST VISIT TO THE CLINIC SINCE IMPLANT. IT WAS ALSO NOTED THAT THIS PATIENT HAD RECEIVED SEVERAL SHOCKS SINCE IMPLANT. A TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THE SHORTENED REPLACEMENT WINDOW (4/05/2007) ADVISORY AND THAT THE BATTERY MAY HAVE DEPLETED DUE TO THE ADVISORY MALFUNCTION OR DUE TO THE MULTIPLE SHOCKS DELIVERED. TS ADVISED INTENSIFYING PATIENT FOLLOW-UPS TO MONTHLY, AND DISCUSSED THE USE OF LATITUDE. THE BATTERY VOLTAGE LATER DECREASED TO 2.59V AND A LONGEVITY ESTIMATE WAS REQUESTED. TS AGAIN DISCUSSED MONTHLY FOLLOW UPS AND WERE NOT ABLE TO PROVIDE A LONGEVITY ESTIMATE DUE TO THE SRW ADVISORY BEHAVIOR. ANOTHER LONGEVITY ESTIMATE WAS REQUESTED AT A LATER DATE, AND IT WAS NOTED THAT THE PATIENT STARTED FEELING WHAT WAS BELIEVED TO BE DIAPHRAGMATIC STIMULATION (OR SOMETHING LIKE IT) FOR THE PAST 2 WEEKS. TS AGAIN DISCUSSED THAT THE PATIENT SHOULD CONTINUE TO BE FOLLOWED MONTHLY. FOR THE PATIENT'S SYMPTOMS, THEY DISCUSSED DAILY MEASUREMENT TIMING AND IF THE STIMULATION WAS FROM THE DAILY LEAD TEST, THE PATIENT WOULD FEEL IT AT THE SAME TIME EVERY DAY. THIS WAS GOING TO BE DISCUSSED FURTHER. IT WAS LATER NOTED THAT THE BATTERY VOLTAGE DECREASED TO 2.55, AND THE CHARGE TIME WAS 13.1 SECONDS. ANOTHER LONGEVITY ESTIMATE WAS REQUESTED; HOWEVER, TS STATED AGAIN THAT AN ACCURATE ESTIMATE COULD NOT BE PROVIDED DUE TO THE SRW ADVISORY. ADDITIONAL INFORMATION WAS PROVIDED THAT THE BATTERY VOLTAGE WAS LATER NOTED TO HAVE DECREASED TO 2.51, AND ERI INDICATORS WERE QUESTIONED. TS DISCUSSED ERI WOULD BE AT 2.50 V, IT WAS THEN NOTED THE PATIENT WOULD BE SCHEDULED FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other THE DEVICE 0158/148291 WAS IMPLANTED 13-JUL-2006