BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2050491 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04247
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION WAS PERFORMED AND THE ICD WAS SUCCESSFULLY REPLACED. BOTH LEADS WERE CAPPED AND REPLACED AS WELL. THE ICD IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS. ONCE ANALYSIS IS COMPLETED, THIS REPORT WILL BE UPDATED.

    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. MICROSCOPIC INSPECTIONS OF THE SEAL PLUGS FOUND THEM TO BE INTACT. ALL SETSCREWS MOVED FREELY AND WITHOUT ISSUE. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, 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 WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE FIELD OBSERVATIONS OF NOISE AND OVERSENSING. THIS DEVICE MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    THE ICD WAS RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED EPISODES DUE TO NOISE OVERSENSING ON A COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD. IN ADDITION THERE WAS NOISE OBSERVED ON THE SHOCK CHANNEL OF THE IMPLANTED DEFIBRILLATION LEAD. 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 Required Intervention