BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2041605 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01139
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT LOSS OF CAPTURE WAS NOTED FOLLOWING THE IMPLANT PROCEDURE. A CONNECTION ISSUE WAS SUSPECTED. AS A RESULT, THE POCKET WAS REOPENED. THE ATRIAL AND VENTRICULAR LEADS WERE REMOVED FROM THE HEADER AND RE-INSERTED. ALL MEASUREMENTS WERE APPROPRIATE. NO ADVERSE PATIENT EFFECTS NOTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention