BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2151472 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07800
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT ATRIAL (RA) PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 3,000 OHMS WITH NO CAPTURE. OVERSENSING WAS OBSERVED, WHICH WAS ALSO REPRODUCED DURING ISOMETRIC TESTING. THE PATIENT IMPLANTED WITH THIS DEVICE REPORTED SYMPTOMS OF AN INCREASE IN FATIGUE AND SHORTNESS OF BREATH FOR APPROXIMATELY TWO TO THREE WEEKS. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE RA LEAD WAS EXPLANTED AND REPLACED. NO OTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    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 64 YR 4087| T180| 0185