BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 517491 · Received March 15, 2004

    Report

    Report Number
    MW1031518
    Event Type
    Injury
    Date Received
    March 15, 2004
    Date of Event
    February 9, 2004
    Report Date
    March 15, 2004
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HERE IN 2003 FOR REVISION AND REPLACEMENT OF INTRATHECAL INFUSION CATHETER. PT RETURNED TO OR IN 2004 FOR REVISION OF INTRATHECAL CATHETER DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INTRATHECAL CATHETER LKK MEDTRONIC 89 CM STERILE *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R