BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1032930 · Received April 23, 2008

    Report

    Report Number
    6000030-2008-02154
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A SPINAL CORD PROCEDURE WHERE SPINAL HARDWARE WAS BEING REMOVED. DURING THE PROCEDURE, THE SURGEON REMOVED THE DISTAL PORTION OF A PREVIOUSLY IMPLANTED CATHETER AND PULLED OUT THE DISTAL PORTION. THE PT PRESENTED ADDITIONAL COMPLICATIONS RELATED TO THE PROCEDURE (NOT SPECIFIED). THE SURGEON ATTEMPTED TO REPLACE THE DISTAL PORTION OF THE CATHETER; HE WAS UNABLE TO ACCESS THE INTRATHECAL SPACE ON THREE OR FOUR ATTEMPTS. THE CATHETER WAS NOT REPLACED; THE EXISTING CATHETER WAS LEFT INSIDE PT. THE PT WAS IN RECOVERY AFTER THE SPINAL SURGERY AND HIS CONDITION WAS REPORTED AS SERIOUS. THE PUMP WAS USED TO DELIVER A MIXTURE OF BACLOFEN 4000MCG/ML AND FENTANYL. THE PHYSICIAN BELIEVED THAT THE PT WAS NOT GETTING THE MEDICATION. THE MFR REP WAS NOT ABLE TO INTERROGATE PT'S PUMP; THE HEALTH CARE TEAM WAS PLANNING TO PROGRAM THE PUMP TO THE LOWEST RATE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 N096505015

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PROGRAMMER MODEL PROGRAMMER| IMPLANTABLE INFUSION PUMP MODEL 8627L18| LOT# NGH038492R| EXPLANTED: