BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 968187 · Received November 16, 2006

    Report

    Report Number
    2032836-2006-00001
    Event Type
    Injury
    Date Received
    November 16, 2006
    Date of Event
    August 31, 2006
    Report Date
    November 8, 2006
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN SURGERY FOR MITRAL AND AORTIC VALVE REPLACEMENT WITH CARDIOPULMONARY BYPASS. TEMPORARY CARDIAC PACEMAKER SJM MODEL 3085 IN USE ON PT. WHEN MOVING PT AT END OF CASE IT WAS NOTED THAT THE PT WAS BRADYCARDIC. PACEMAKER WOULD NOT STIMULATE THE VENTRICLE. PACEMAKER INDICATED VENTRICULAR OUTPUT ALARM AND ALARM OF ATRIAL OUTPUT SHORT. ALL CONNECTIONS WERE CHECKED. NO WIRES WERE CROSSED. PT BRADYCARDIC TO 30'S AND HYPOTENSIVE TO 60'S FOR UP TO 1.5 MIN. NO UNDERLYING NORMAL HEART RHYTHM. REPLACED PACEMAKER WITH SAME MODEL BACKUP PACEMAKER. CAPTURE AND RESTORING OF NORMAL RHYTHM. ALARM FOR ATRIAL OUTPUT SHORT REMAINED DESPITE SUCCESSFUL STIMULATION. REPLACED PACEMAKER WITH SAME MODEL BACKUP PACEMAKER. CAPTURE AND RESTORING OF NORMAL RHYTHM. ALARM FOR ATRIAL OUTPUT SHORT REMAINED DESPITE SUCCESSFUL STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL TEMPORARY CARDIAC PACEMAKER DTE OSYPKA MEDICAL GMBH 3085 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R