BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOR

    MDR report key: 19557 · Received September 30, 1994

    Report

    Report Number
    1832085-1994-00001
    Event Type
    Injury
    Date Received
    September 30, 1994
    Date of Event
    September 8, 1994
    Report Date
    September 14, 1994
    Manufacturer
    VASCOR MEDICAAL CORPORATION
    Product Code
    DTD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON SEP. 8, 1994 A PHYSICIAN WAS IMPLANTING A PACEMAKER. DURING THE COURSE OF THE OPERATION THE PT'S VENTRICLE WAS PERFORATEED WITH A PACING LEAD. THE PERFORATION RESULTED IN A PARICARDIAL AFFUSION AND TAMPINOD. A THORACOTOMY WAS PERFORMED AND THE PERICARDIUM WAS OPENED AND THE FLUID EVACUATED. AT THIS TIME THE PT WAS IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOR Implant PACING LEAD DTD VASCOR MEDICAAL CORPORATION 111-256

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention