BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2163525 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07780
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    October 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. NO DATE/INITIALS ARE NEEDED HERE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT 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 DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION AND NORMAL BATTERY DEPLETION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. A REQUEST FOR THE RETURN OF THE PRODUCT WAS MADE. IF THE PRODUCT IS RETURNED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO THE CHARGE TIME MEASUREMENTS EXCEEDING THE EXTENDED CHARGE TIME LIMIT. THE MONITORING VOLTAGE WAS 2.56 AND THE CHARGE TIME WAS 23.5 SECONDS. THE DEVICE REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    OUR COMPANY RECEIVED ADDITIONAL INFORMATION TWO MONTHS LATER THAT THE DEVICE WAS EXPLANTED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 0184| T165| 4469