BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2052652 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03994
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    March 7, 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

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A CHARGE TIME (CT) OF 17.4 SECONDS, AND IT WAS QUESTIONED IF THIS CT WAS NORMAL. TECHNICAL SERVICES (TS) DISCUSSED THE CT BEHAVIOR. ADDITIONAL INFORMATION WAS PROVIDED THAT DURING A NORMAL DEVICE FOLLOW-UP CHECK, THE CT WAS FOUND TO BE 20.5 SECONDS AND THE BATTERY VOLTAGE WAS 2.57. TS ADVISED TO PERFORM ANOTHER MANUAL CAPACITOR REFORMATION WHICH RESULTED IN A DECREASED CT OF 17.2 SECONDS. TS DISCUSSED THE MIDLIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY BEHAVIOR AND ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO CT. IT WAS NOTED THAT THIS WOULD BE DISCUSSED FURTHER WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention T175| 0185