BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2051824 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03629
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    June 2, 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

    THE DEVICE HAS BEEN RETURNED AND IS CURRENTLY IN ANALYSIS. WHEN ANALYSIS IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED ANALYSIS CONFIRMED THE ATRIAL RING HEADER WIRE WAS NOT PROPERLY WELDED DURING THE MANUFACTURING PROCESS. THIS FINDING LIKELY CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS OF THE HIGH ATRIAL PACING IMPEDANCE MEASUREMENTS FOUND FOLLOWING THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE KEPT DISPLAYING ATRIAL LEAD IMPEDANCES GREATER THAN 2,500 OHMS POST IMPLANT. THE PATIENT'S POCKET WAS REOPENED AND THE LEAD WAS TESTED THROUGH THE PACING SYSTEM ANALYZER AND NORMAL IMPEDANCES WERE NOTED. THE PHYSICIAN TRIED REINSERTING THE LEAD INTO THE DEVICE HEADER AND CHECKED CONNECTIONS AND OUT OF RANGE IMPEDANCES WERE STILL OBSERVED. THE PHYSICIAN ELECTED TO REMOVE THIS DEVICE AND IMPLANT A NEW DEVICE. IMPEDANCE MEASUREMENTS WERE NORMAL WITH THE NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R