BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1853433 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14597
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED AND RESUBMITTED UPON RETURN AND COMPLETION OF ANALYSIS.

    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 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, THIS DEVICE EXHIBITED LOSS OF CAPTURE ON THE RIGHT ATRIAL (RA) CHANNEL. A REVISION PROCEDURE WAS PERFORMED. THE RA LEAD WAS REPOSITIONED AND TESTS OF THE LEAD CONFIRMED IT WAS OPERATING AS EXPECTED. AFTER RECONNECTING THE LEAD TO THE DEVICE, NOISE WAS NOTED WITH NO SENSING AND AN IMPEDANCE MEASUREMENT GREATER THAN 2500 OHMS. THE LEAD WAS DISCONNECTED, AND LEAD TESTING AGAIN NOTED NORMAL MEASUREMENTS. THE LEAD WAS RECONNECTED TO THE DEVICE SEVERAL TIMES, BUT THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE OBSERVED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S208

    Patients

    Seq Age Sex Outcome Treatment
    1