BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT

    MDR report key: 49163 · Received November 8, 1996

    Report

    Report Number
    49163
    Event Type
    Injury
    Date Received
    November 8, 1996
    Date of Event
    August 20, 1996
    Report Date
    October 29, 1996
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD PORT IMPLANTED ON 9/25/92. ON 8/19/96, THE PT WAS ADMITTED FOR NECK AND SUPRA CAVA SWELLING AND SHORTNESS OF BREATH. CT SCAN REVEALED EXTENSIVE THROMBOSIS IN THE SUPERIOR VENA CAVA AND LEFT BRACHIAL CEPHALIC VEIN AROUND THE CATHETER. PHYSICIAN NOTES STATE THAT PORT FLUSHED INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL-PORT Implant PORT-A-CATH LJT COOK PACEMAKER CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention