BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2042357 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01329
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    August 9, 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 MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. AT THIS TIME, THERE IS NO FURTHER INFORMATION TO PROVIDE. THEREFORE, THE INVESTIGATION IS CONSIDERED COMPLETE UNTIL SUCH TIME THAT NEW INFORMATION WOULD BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THERE WAS ADDITIONAL INQUIRY AS TO CHARGE TIME AND DEVICE BEHAVIOR. HOWEVER, ALL INDICATIONS OF DEVICE BEHAVIOR INDICATE THAT THIS DEVICE IS PERFORMING WITHIN NORMAL LIMITS ACCORDING TO THE LABELING SPECIFICATIONS OF THIS DEVICE (EXTENDED ERI CHARGE TIME LIMIT: > 26.1 SEC FROM 3.00 TO 2.55 V AND THIS DEVICE HAS NOT REACHED THESE PARAMETERS TO DATE). THIS DEVICE HAS CLEARED THE SHORTENED REPLACEMENT WINDOW ADVISORY BEHAVIOR AND HAS NOT YET REACHED ELECTIVE REPLACEMENT INDICATOR. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THE BEHAVIOR OF THIS DEVICE. THIS REPORT WAS ORIGINALLY FILED IN ERROR, DUE TO THE TONE OF THE LONGEVITY INQUIRY. THE DECISION FOR THIS REPORT HAS BEEN AMENDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY (B)(6) 2009 POPULATION PRODUCT ADVISORY INITIALLY COMMUNICATED ON (B)(6) 2007, DISPLAYED A MONITORING VOLTAGE MEASUREMENT OF 2.68 VOLTS, AND THEN ONLY THREE MONTHS LATER EXHIBITED A MONITORING VOLTAGE MEASUREMENT OF 2.63 VOLTS AND A CHARGE TIME MEASUREMENT OF 21 SECONDS. THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED BY THE MEDICAL PERSONNEL. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DID NOT RECOMMEND IMMEDIATE DEVICE CHANGEOUT. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 0158| T180