BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 1890178 · Received November 3, 2010

    Report

    Report Number
    2124215-2010-21452
    Event Type
    Death
    Date Received
    November 3, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS REMAINED IMPLANTED AND THEREFORE, WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE PATIENT WITH THIS PACING SYSTEM PASSED AWAY. THE PATIENT HAD AN EXTREMELY CALCIFIED AORTIC VALVE AND PRESENTED WITH THREE TO FIVE SECOND PAUSES ON TELEMETRY DUE TO SINUS NODE DYSFUNCTION. DURING THE IMPLANT PROCEDURE, THE PATIENT DEVELOPED INTERMITTENT COMPLETE HEART BLOCK. IT WAS REPORTED THAT THE PACING SYSTEM WAS IMPLANTED AND FUNCTIONING APPROPRIATELY; HOWEVER, THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 Death