BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1022762 · Received March 28, 2008

    Report

    Report Number
    6000030-2008-01662
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 27, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID LEAK AND SEROMA; THE PT REPORTED NOT HAVING THERAPEUTIC EFFECT. A CATHETER BLOCKAGE WAS CONFIRMED AND SURGICAL REVISION WAS PERFORMED IN '08 AND THE PROBLEM WAS RESOLVED, ALTHOUGH THE PT WAS STILL NOT GETTING RELIEF FROM PAIN. THE HCP IS STILL TITRATING THE DOSE TO FIND RIGHT AMOUNT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED:| PUMP MODEL #: 863740