BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2173654 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10954
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 15, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THIS DEVICE SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS INVESTIGATION WILL BE REOPENED AND UPDATED AS NECESSARY. 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

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED AND REPLACED BY A BI-VENTRICULAR DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT DEVICE FOLOOW UP APPOINTMENT, THIS DEVICE WAS UNABLE TO BE INTERROGATED. A SECOND ATTEMPT TO INTERROGATE WILL BE DONE AT THE NEXT APPOINTMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S601

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR 4087| S601