BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1032790 · Received April 23, 2008

    Report

    Report Number
    6000030-2008-02135
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    January 1, 2003
    Report Date
    March 20, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004/S39
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER DISLODGED FROM THE INTRATHECAL SPACE. THE HCP REPLACED THE DEVICE SYSTEM. NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES LIORESAL. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8709 J10924R44

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PUMP MODEL #8627L18| EXPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED| IMPLANTED