BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2170282 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09958
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    March 15, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EIGHT MONTHS LATER, THE DEVICE WAS ELECTIVELY REPLACED. THE DEVICE HAS SINCE BEEN RETURNED AND IS CURRENTLY IN ANALYSIS. WHEN ANALYSIS IS COMPLETE, THIS REPORT WILL BE UPDATED. UPON RECEIPT AT OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS 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 WAS OBSERVED. THE DEVICE WAS EXPLANTED PRIOR TO REACHING END OF LIFE (EOL).

    Additional Manufacturer Narrative · 1

    THE DEVICE AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN SERVICE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXHIBITING CROSS-TALK ON THE VENTRICULAR CHANNEL WITH SOME PACING INHIBITION. THE PATIENT HAD MILD SYMPTOMS REPORTED. TECHNICAL SERVICES DISCUSSED PROGRAMMING OPTIONS TO ALLEVIATE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 0158| T125| 4469