BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3043575 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02525
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 28, 2013
    Report Date
    September 5, 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

    --

    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

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS BROUGHT BACK TO THE CLINIC TO ATTEMPT DEVICE INTERROGATION. THE DEVICE WAS UNABLE TO BE INTERROGATED AND THE PRM DISPLAYED AN UNSUPPORTED SOFTWARE MESSAGE. THE MAGNET RATE OF THE DEVICE WAS 100, THEREFORE, THE DEVICE APPEARED TO BE FUNCTIONING AS DESIGNED. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED TROUBLESHOOTING TECHNIQUES. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED AND RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED. TECHNICAL SERVICES WAS CONSULTED AND INSTRUCTED THE HEALTH CARE PROFESSIONAL (HCP) THROUGH INTERROGATION TROUBLESHOOTING. IT WAS FOUND THAT THE PROGRAMMER RECORDER MONITOR (PRM) HAD OUTDATED SOFTWARE VERSIONS. IT WAS UNKNOWN IF THIS WAS THE CAUSE OF THE INABILITY TO INTERROGATE. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147008 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR S606| 4457| 4469