BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2173766 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10552
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 2, 2011
    Report Date
    August 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003/S106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, 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. 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. THE CLINICAL OBSERVATIONS WERE NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE FOR THIS PULSE GENERATOR, DIFFICULTIES WITH A SET SCREW WERE ENCOUNTERED. THE DEVICE SYSTEM HAD BEEN IMPLANTED AND THE PATIENT WAS READY TO BE TAKEN INTO RECOVERY WHEN IT WAS DISCOVERED THAT THE ASSOCIATED RIGHT ATRIAL LEAD HAD DISLODGED. THE POCKET HAD TO BE REOPENED. A NEW RA LEAD WAS IMPLANTED. WHEN THE DEVICE WAS ATTEMPTED TO BE RECONNECTED TO THE LEAD, THE PHYSICIAN WAS UNABLE TO TURN ONE OF THE SET SCREWS ON THE DEVICE. THE DEVICE WAS NOT ABLE TO BE RE-IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE IS TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 4480| S606| 4136| 4137