BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1781247 · Received August 3, 2010

    Report

    Report Number
    2124215-2010-15196
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    April 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE WEEK POST IMPLANT, THE LEAD WAS STILL EXHIBITING ACCEPTABLE UNIPOLAR IMPEDANCE MEASUREMENTS AND THEREFORE, REMAINS IN UNIPOLAR CONFIGURATION. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT'S PACING SYSTEM CONSISTS OF A BOSTON SCIENTIFIC PACEMAKER AND COMPETITIVE ATRIAL AND RIGHT VENTRICULAR LEADS. POST IMPLANT CHECK OF THE SYSTEM NOTED RIGHT VENTRICULAR BIPOLAR IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. HOWEVER, IMPEDANCE WAS 430 OHMS IN UNIPOLAR CONFIGURATION.

    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