BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM

    MDR report key: 3143376 · Received May 24, 2013

    Report

    Report Number
    2183502-2013-00252
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SMITHS MEDICAL
    Product Code
    LNY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    FROM CLINICAL TRIAL STUDY ORGANIZER: IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN PT FOR ADMINISTRATION OF CLINICAL TRIAL DRUG ON (B)(6) 2012. ACCORDING TO THE REPORT, IT WAS DIFFICULT TO OBTAIN SAMPLES OF CEREBROSPINAL FLUID AND DIFFICULT TO FLUSH THE SYSTEM DURING THE PT'S MOST RECENT INFUSION APPOINTMENT (DATE NOT PROVIDED). THE DEVICE WAS SURGICALLY EXPLANTED ON (B)(6) 2013. PT WAS DISCHARGED FROM HOSPITAL CARE ON (B)(6) 2013. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232911 PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM LNY - CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL LNY SMITHS MEDICAL 21-1500 1768497

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention