BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2173250 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10439
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    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, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHILE THIS PATIENT, IMPLANTED WITH THIS PACEMAKER, WAS VISITING HER SON IN THE HOSPITAL, SHE EXPERIENCED A VENTRICULAR FIBRILLATION ARREST AND HAD TO BE EXTERNALLY RESCUED. IT WAS DETERMINED THAT THE DEVICE WAS UNDERSENSING P-WAVES AND THEN DUE TO THE CROSS CHAMBER BLANKING, THE VENTRICULAR PACE WOULD COME APPROXIMATELY FOLLOWING THE INTRINISIC VENTRICULAR EVENT THAT WAS BEING BLANKED. THE PATIENT'S ATRIAL SENSITIVITY SETTINGS WERE ADJUSTED DUE TO LOW P-WAVE MORPHOLOGY. THE PHYSICIAN IS PLANNING TO UPGRADE THE PATIENT TO A TACHYCARDIA DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R S603| 4076