BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3212559 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08444
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    TO DATE THIS DEVICE REMAINS IN SERVICE AND HAS NOT BEEN RETURNED AND THEREFORE A TECHNICAL ANALYSIS CANNOT BE CONDUCTED. WITHOUT A RETURNED DEVICE IT IS NOT POSSIBLE TO DEFINITELY CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TWO YEARS POST IMPLANT, THIS DEVICE REACHED ELECTIVE REPLACEMENT NEAR (ERN). ANALYSIS WAS REQUESTED OF THE DEVICE AS PREMATURE BATTERY DEPLETION (PBD) WAS SUSPECTED DUE TO POSSIBLE HIGH OUTPUTS OR EARLY DISCHARGE OF THE BATTERY. ALL OTHER MEASUREMENTS WERE REVIEWED AND ARE WITHIN NORMAL AND ACCEPTABLE RANGES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313903 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S502

    Patients

    Seq Age Sex Outcome Treatment
    1