BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1032788 · Received April 23, 2008

    Report

    Report Number
    6000030-2008-02138
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 21, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD FLIPPED IN THE POCKET AND THE CATHETER WAS KINKED. THE HCP WAS UNABLE TO ACCESS THE RESERVOIR PORT AND REFILL THE PUMP. THE PUMP STARTED TO ALARM AND RAN DRY FOR THREE WEEKS. THE PT EXPERIENCED WITHDRAWAL SYMPTOMS (NOT SPECIFIED) AND HAD THROWN UP BLOOD. SHE HAD BEEN DISCHARGED FROM HER PREVIOUS PAIN CLINIC, HAD MOVED, AND WAS UNABLE TO FIND AN HCP TO REFILL THE PUMP OR REVISE THE PUMP. IT WAS ALSO REPORTED THAT THE PT COULDN'T FIND AND HCP TO REFILL THE PUMP BECAUSE IT WAS "PLUGGED." THE PT WAS AT HOME AND HER CONDITION WAS 'FAIR.' IT WAS REPORTED THAT THE PUMP WAS REVISED (DATE NOT REPORTED). THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE DEVICE SYSTEM WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. 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 J0058151R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| PUMP MODEL #863720| IMPLANTED| IMPLANTED| CATHETER MODEL 8575 LOT# N105436| EXPLANTED