BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1041322 · Received May 9, 2008

    Report

    Report Number
    6000030-2008-02512
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 10, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    SINCE THE PUMP WAS IMPLANTED 2 WEEKS AGO, THE PT HAD A DECREASE IN SYMPTOM RELIEF AND EXPERIENCED SWELLING IN DIFFERENT PARTS OF HIS BODY. THE MEDICATION DOSAGE WAS INCREASED THE FOLLOWING WEEK. A CATHETER DYE STUDY WAS PERFORMED LATER THAT SAME WEEK WHICH SHOWED THE CATHETER HAD DISLODGED FROM THE INTRATHECAL SPACE. THE PUMP FLOW RATE WAS NOT DECREASED AND CATHETER REPLACEMENT WAS PLANNED FOR THE FOLLOWING WEEK. THE PT WAS REPORTED TO HAVE RECOVERED WITHOUT SEQUELAE. THE PUMP WAS USED TO DELIVER MORPHINE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8731 N135136015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PUMP MODEL # 863720 IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED: