BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR MAX II

    MDR report key: 1781701 · Received August 3, 2010

    Report

    Report Number
    2124215-2010-15290
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    May 27, 2010
    Report Date
    December 13, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-875/897-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A TS REPRESENTATIVE DISCUSSED THAT THERE ARE 90 DAYS BETWEEN ERI AND EOL AND IF SOMETHING HAD CHANGED IN PROGRAMMING, PACING, OR IMPEDANCES, THIS COULD HAVE CAUSED THE DEVICE TO REACH ERI MUCH SOONER. AT THIS TIME, THIS DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE HAD NORMAL TELEMETRY FUNCTIONS. 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 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. LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE PACEMAKER REACHED END OF LIFE (EOL) WITHOUT EVER DISPLAYING THE ELECTIVE REPLACEMENT INDICATOR (ERI). NO ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED TO DISCUSS THIS BEHAVIOR.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1280

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 1280| 4092| 4480