BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 861330 · Received June 5, 2007

    Report

    Report Number
    6000030-2007-01917
    Event Type
    Malfunction
    Date Received
    June 5, 2007
    Report Date
    May 21, 2007
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2006, THE PT DEVELOPED LIVER FAILURE AND ASCITIS; THE PUMP POCKET KEPT FILLING WITH FLUID. THE PHYSICIAN DID NOT BELIEVE THE POCKET FLUID WAS RELATED TO THE ASCITIS OR TO THE LIVER FAILURE. DURING DEVICE EXPLANT THEY FOUND "THE PUMP FLIPPING AROUND IN THE POCKET AND FLUID AROUND THE PUMP THAT THE REFILL DOCTOR REFUSED TO REMOVE ANY LONGER," THE CATHETER WAS FOUND DISCONNECTED FROM THE PUMP. THE PT REPORTED THEY HAD EXPERIENCED NO PAIN RELIEF FROM THE PUMP THERAPY; THE PT FEELS BETTER SUBSEQUENT TO HAVING THE PRODUCT REMOVED. THE DRUG USED IN THE PUMP IS MORPHINE. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN. SEE MFR REPORT # 6000030-2007-01916.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709AA N005424124

    Patients

    Seq Age Sex Outcome Treatment
    1 YR PROGRAMMER MODEL UNK LOT # UNK| CATHETER MODEL 8703W LOT#L564741| IMPLANTED| EXPLANTED