BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1052941 · Received May 27, 2008

    Report

    Report Number
    6000030-2008-02828
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 25, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT WAS NO LONGER GETTING PAIN RELIEF. THE RADIOLOGIST WAS UNABLE TO ASPIRATE THE CATHETER DURING A CATHETER DYE STUDY (DATE NOT REPORTED). THE PUMP AND CATHETER WERE REPLACED. BLACK RESIDUE WAS SEEN IN THE CATHETER PUMP CONNECTOR BY THE PHYSICIAN AT EXPLANT. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. 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 J0056579R

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 8627L18| LOT# NGH012118R