BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 800587 · Received January 3, 2007

    Report

    Report Number
    6000030-2006-02420
    Event Type
    Injury
    Date Received
    January 3, 2007
    Report Date
    December 2, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTS A SORE BUMP DEVELOPING IN THE CENTER OF THEIR SPINE APPROXIMATELY WHERE THE CATHETER WAS IMPLANTED. THE BUMP IS DESCRIBED AS THE SIZE OF A LARGE MARBLE AND SORE ESPECIALLY TO THE TOUCH. THE PATIENT IS WORRIED THE CATHETER HAS DISLODGED OR IS BLOCKED. THE PATIENT PLANNED TO DISCUSS THIS WITH THEIR HCP. THE PATIENT REPORTED NO OTHER SYMPTOMS BESIDES GENERAL SORENESS IN THE AREA. THE DRUG USED IN THE PUMP IS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE ON THE DAE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK LKK RICE CREEK MANUFACTURING 8709AA J12565R08

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention PROGRAMMER MODEL 8840| IMPLANTED| LOT # UNK| EXPLANTED| IMPLANTED| LOT# NGV011966N| EXPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863740