BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1040042 · Received May 7, 2008

    Report

    Report Number
    6000030-2008-02429
    Event Type
    Injury
    Date Received
    May 7, 2008
    Report Date
    April 8, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED INCREASED PAIN. THE CATHETER WAS FOUND TO BE OCCLUDED (TROUBLESHOOTING METHOD NOT REPORTED) AND WAS REPLACED. THE PT OUTCOME WAS REPORTED AS GOOD. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8703W L48425

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED| PUMP MODEL # 8627-18| EXPLANTED