BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM

    MDR report key: 2850977 · Received November 19, 2012

    Report

    Report Number
    2183502-2012-00567
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    LNY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    FROM CLINICAL TRIAL STUDY ORGANIZER: IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN PATIENT FOR ADMINISTRATION OF CLINICAL TRIAL DRUG ON (B)(6) 2010. ACCORDING TO REPORT FROM CLINICAL TRIAL ORGANIZER THE PATIENT SHOWED SYMPTOMS OF INFECTION INCLUDING SUBFEBRILE TEMPERATURE AND SWELLING AT INFUSION SITE ON (B)(6) 2012. PATIENT WAS TREATED WITH PARACETAMOL. THE TREATING FACILITY REPORTED THAT TESTS OF PATIENT BLOOD SHOWED (B)(6) INFECTION. PATIENT WAS THEN TREATED WITH VANCOMYCIN AND CEFTRIAXON INFUSION. DEVICE WAS EXPLANTED ON (B)(6). PATIENT WAS DISCHARGED FROM HOSPITAL CARE ON (B)(6) WITH NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention