BEUDAMED
    FDA Adverse Event Other Summary report: N

    IDEAS PORT TITANIUM

    MDR report key: 486342 · Received September 29, 2003

    Report

    Report Number
    1049753-2003-00001
    Event Type
    Other
    Date Received
    September 29, 2003
    Date of Event
    June 2, 2003
    Report Date
    August 11, 2003
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 1997, PATIENT WITH SIGNIFICANT HISTORY OF SICKLE CELL ANEMIA HAD A VENOUS ACCESS DEVICE IMPLANTED. AT APPROXIMATELY 6 YEARS POSTOPERATIVELY, DURING SICKLE CELL CRISIS, THE PATIENT COMPLAINED OF PAIN IN THE RIGHT ARM AND EXPERIENCED EDEMA IN THE RIGHT ARM AND FOREARM. AN ULTRASOUND WAS PERFORMED AT THE SITE THAT DEMONSTRATED A CLOT IN THE RIGHT INTERNAL JUGULAR VEIN AND NO FLOW IN THE SUBCLAVIAN ARTERY. ACCORDING TO THE REPORT, THE VENOUS ACCESS DEVICE WAS SUBSEQUENTLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDEAS PORT TITANIUM VENOUS ACCESS PORT LJT CRYOLIFE, INC. NA T101597-41

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| O| R