BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1040047 · Received May 7, 2008

    Report

    Report Number
    6000030-2008-02424
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    January 1, 2007
    Report Date
    April 29, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD FLUID BUILD UP AROUND THE PUMP 6-8 MONTHS PRIOR TO CALLING THE MANUFACTURER. THE FLUID WAS PALPABLE, BUT NOT VISIBLE. SEVEN MONTHS PRIOR TO THE REPORT, AN ALARM WAS HEARD AND THE PT'S PUMP WAS REFILLED. SIX MONTHS PRIOR TO REPORT, THE PHYSICIAN REMOVED ONE HALF CUP OF FLUID. THE HCP TOLD THE PT THE FLUID WAS WATER OR CEREBROSPINAL FLUID. THE PT FELT 'WEIRD' FOR A MONTH PRIOR TO HER REFILL ON 04/25/2008. HER MUSCLES WERE TIGHT, BUT NOT TOO TIGHT, AND SHE FELT NERVOUS. AN X-RAY WAS TAKEN (DATE NOT REPORTED) AND NO PROBLEM WAS FOUND. THERE WERE NO VOLUME DISCREPANCIES. THE PT UNDERWENT CATHETER REVISION SURGERY IN 2008. HALF OF THE CATHETER WAS REPLACED BECAUSE A 'KNOT' WAS FOUND. THE PT WAS ADMITTED TO THE HOSPITAL. A MAGNETIC RESONANCE IMAGING HAD BEEN ORDERED BY THE HCP (REASON NOT REPORTED). THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 J12399R25

    Patients

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