BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1852707 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14548
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003/S106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ORIGINALLY IT WAS SUSPECTED THE RIGHT VENTRICULAR LEAD FRACTURED DUE TO HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. HOWEVER, THE PHYSICIAN REOPENED THE DEVICE POCKET AND FOUND IT WAS NOT THE LEAD ITSELF THAT WAS ATTRIBUTING TO THE HIGH IMPEDANCES, IT WAS A SET SCREW ISSUE. THE PHYSICIAN TUGGED ON BOTH LEADS AND THE RIGHT VENTRICULAR LEAD SEEMED TIGHT. THE LEAD WAS DISCONNECTED FROM THE PACEMAKER AND CONNECTED TO THE ANALYZER AND APPROPRIATE MEASUREMENTS WERE OBTAINED. THE LEAD WAS RECONNECTED TO THE DEVICE AND DEVICE BASED TESTING SHOWED GOOD IMPEDANCES, THRESHOLD AND SENSING MEASUREMENTS. THE SYSTEM WAS RECHECKED THE FOLLOWING MORNING AND ALL EVERYTHING APPEARED FINE.

    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 87 YR Life Threatening 4469| 4470| S606