BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2173153 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10474
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY DETERMINED THAT THE DEVICE HAD NORMAL TELEMETRY OPERATIONS, AS WELL AS NORMAL PACING AND SENSING FUNCTIONS. A REVIEW OF THE DEVICE'S MEMORY REVEALED THAT A RATE FAULT RESET WAS STORED IN THE RESET COUNTER. LABORATORY TESTING HAS SHOWN THAT THE AUTO LEAD DETECT FEATURE CAN CAUSE A RATE FAULT RESET TO OCCUR, DUE TO THE MAX TRACKING RATE PROTECTION NOT BEING INITIALIZED. THIS TYPE OF RESET OCCURS PRIOR TO LEAD ATTACHMENT. ONCE A LEAD IS DETECTED, THE AUTO LEAD DETECT FEATURE WILL BE DISABLED, ALLOWING THE MAX TRACKING RATE PROTECTION TO BE INITIALIZED, PREVENTING THE RATE FAULT RESETS FROM OCCURRING. THIS BEHAVIOR DOES NOT HAVE ANY IMPACT ON THE THERAPY PROVIDED TO THE PATIENT AS IT ONLY OCCURS PRIOR TO LEAD ATTACHMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS RETURNED WITH NO ADDITIONAL INFORMATION. THERE WERE NO KNOWN ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION, FUNCTIONALITY OR LONGEVITY. THIS DEVICE FAILED INITIAL ANALYSIS WHEN RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. FURTHER ANALYSIS TO BE COMPLETED.

    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 77 YR S601| 4470