BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM

    MDR report key: 2926296 · Received January 18, 2013

    Report

    Report Number
    2183502-2012-00658
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 3, 2012
    Manufacturer
    SMITHS MEDICAL MD, INC.
    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 EVALUATION. 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 EVALUATION.

    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 REPORT, ON (B)(6) 2012, COULD NOT BE ACCESSED TO ALLOW FOR ADMINISTRATION OF SCHEDULED CLINICAL TRIAL. IN (B)(6) 2012, THE PT HAD SURGERY TO REVISE THE SYSTEM. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27723 PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM LNY-CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL LNY SMITHS MEDICAL MD, INC. 21-1500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention