BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC CONTROL SYSTEMS

    MDR report key: 35439 · Received June 28, 1996

    Report

    Report Number
    35439
    Event Type
    Injury
    Date Received
    June 28, 1996
    Date of Event
    February 19, 1996
    Report Date
    February 29, 1996
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS AN 84 YR OLD MALE PT WHO HAD A PRIOR PACEMAKER IMPLANTED FOLLOWING AORTIC VALVE REPLACEMENT BECAUSE OF HEART BLOCK. HE WAS FOLLOWED BY HIS CARDIOLOGIST AND HAS BEEN DOCUMENTED TO HAVE PACEMAKER MEDIATED TACHYCARDIA. ON 2/19/96, HE WAS SEEN IN DAY SURGERY TO HAVE THE PULSE GENERATOR CHANGED UNDER GENERAL ANESTHESIA. THE OLD PULSE GENERATOR WAS REMOVED. THE ATRIAL AND VENTRICULAR LEADS WERE NORMAL AND CONNECTED TO A CO'S PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC CONTROL SYSTEMS Implant MAESTRO PULSE GENERATOR DXY CARDIAC CONTROL SYSTEMS, INC. 505 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization ATRIAL LEAD-MODEL 439-04