BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM

    MDR report key: 3143373 · Received May 24, 2013

    Report

    Report Number
    2183502-2013-00253
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    LNY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER 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 (B)(6): IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN PT FOR ADMINISTRATION OF CLINICAL TRIAL DRUG ON (B)(6) 2012. ACCORDING TO THE REPORT, ON (B)(6) 2013, THE DEVICE WAS NON-FUNCTIONAL DURING INFUSION ATTEMPTS THROUGH THE SYSTEM. THE SYSTEM WAS SURGICALLY IMPLANTED ON (B)(6) 2013. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232910 PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM LNY - CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL LNY SMITHS MEDICAL MD 21-1500 1661867

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention