BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1040272 · Received May 8, 2008

    Report

    Report Number
    6000030-2008-02477
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 9, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT RECENTLY HAD A PUMP REPLACEMENT DUE TO VOLUME DISCREPANCIES (SEE MFG. REPORT # 2182207200801301). THE CATHETER WAS CHECKED INTRA-OPERATIVELY AND FOUND TO BE PATENT WITH GOOD CEREBROSPINAL FLUID FLOW. AFTER IMPLANT OF THE NEW PUMP 2 REFILLS HAD BEEN PERFORMED, BOTH WITH VOLUME DISCREPANCIES WHICH SHOWED NOTHING HAD INFUSED. AT THE FIRST REFILL VISIT THE EXPECTED RESERVOIR VOLUME WAS 9 MLS AND THE ACTUAL VOLUME ASPIRATED WAS 20 MLS. AT THE NEXT VISIT THE EXPECTED RESERVOIR VOLUME WAS 30.9 MLS, AND THE ACTUAL RESERVOIR VOLUME WAS 39 MLS. THE PUMP HAD NO MOTOR STALLS. A CATHETER DYE STUDY WAS ATTEMPTED (DATE NOT REPORTED) BUT THE HCP WAS UNABLE TO GET ANY CSF FLOW AND FELT RESISTANCE WHILE TRYING TO PUSH DYE THROUGH THE CATHETER. A CATHETER REVISION OR REPLACEMENT WAS PLANNED. THE PT HAD INCREASED PAIN AND WAS TAKING ORAL PAIN MEDICATION ON AN AS-NEEDED BASIS. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. 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 MANUFACTURING 8709 N073301020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| PUMP MODEL 867340 LOT# NGV024855N| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK