BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1000716 · Received February 15, 2008

    Report

    Report Number
    6000030-2008-00762
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    May 11, 2005
    Report Date
    June 7, 2005
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    THE PT REPORTED SHE WAS NOT GETTING NEEDED SYMPTOM RELIEF AND WOULD LIKE TO FIND A PHYSICIAN CLOSER TO HOME. THE PT REFERRED TO THE MEDTRONIC PAIN WEBSITE FOR LISTINGS. THE HCP REPORTED THE PT HAD INCREASED PAIN AND THE CATHETER WAS OUT OF THE INTRATHECAL SPACE. SURGERY WAS PERFORMED TO REPLACE THE CATHETER TO THE CORRECT POSITION. THE PT WAS REPORTED TO BE DOING BETTER. THE DRUG USED IN THE PUMP WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8709AA J11974R05

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R