BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 996515 · Received February 8, 2008

    Report

    Report Number
    6000030-2008-00632
    Event Type
    Injury
    Date Received
    February 8, 2008
    Date of Event
    October 16, 2007
    Report Date
    October 16, 2007
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PT EXPERIENCED INCREASED SPASTICITY, PRURITUS, AND MENTAL STATUS CHANGES. A CT REVEALED QUESTIONABLE CATHETER FRACTURE. THE HCP REPORTED THAT THE PT HAS TWO OTHER CATHETERS WHICH ARE STILL IMPLANTED AFTER PREVIOUS CATHETER TEARS. THE PT HAD SURGERY IN 2007, BUT THE HCP WAS UNSURE WHETHER ANY OF THE CATHETERS THAT WERE CURRENTLY IMPLANTED IN THE INTRATHECAL SPACE WOULD BE ABLE TO BE REMOVED. REFERENCE MFR REPORT #: 6000030-2008-00633, 6000030-2008-00634.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention CATHETER MODEL 8575 LOT# J0212417R| IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTABLE INFUSION PUMP MODEL 863740| LOT# NGV018587N| IMPLANTED