BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2170969 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10051
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    May 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS 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 FOLLOWING DEVICE PROGRAMMED SETTINGS WERE CHECKED AND BOTH THE MINUTE VENTILATION AND ACCELEROMETER SENSORS WERE ENABLED WHILE THE DEVICE WAS IMPLANTED. ATRIAL PACING PARAMETERS WERE PROGRAMMED TO 5 VOLTS AT 1 MS AND VENTRICLE PACING PARAMETERS WERE PROGRAMMED TO 2.5 VOLTS AT 0.5 MS. ANALYSIS CONCLUDED THE LONGEVITY WAS GREATLY INFLUENCED BY THE ATRIAL PACING PARAMETERS AND HAVING BOTH RATE SENSORS ENABLED. THIS DEVICE MET LONGEVITY REQUIREMENTS AND DID NOT EXHIBIT A PREMATURE BATTERY DEPLETION CONDITION.

    Additional Manufacturer Narrative · 1

    THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO OUR COMPANY, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS SHOWING A MAGNET RATE OF 90 BPM AFTER ONLY (B)(6) IMPLANTED. PACING OUTPUTS HAVE BEEN LOW IN BOTH CHAMBERS. TECHNICAL SERVICES RECOMMENDED BRINGING THE PATIENT IN FOR A DEVICE CHECK. NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR (B)(4)| (B)(4)| (B)(4)