BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA CATHETER

    MDR report key: 1051452 · Received May 21, 2008

    Report

    Report Number
    6000030-2008-02709
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD NOT BEEN GETTING THERAPY FOR ABOUT THREE MONTHS, NO SPECIFIC SYMPTOMS WERE REPORTED. THE CATHETER WAS FOUND TO BE FRACTURED. A REVISION SURGERY WAS PERFORMED. THE PUMP WAS REPLACED. THE CATHETER WAS BROKEN AT THE PORTION WHERE IT CONNECTS TO THE PUMP. IT WAS REPAIRED; THE SPINAL SEGMENT WAS CUT WHERE IT WAS ANCHORED DOWN AND 1ML OF CSF WAS ASPIRATED TO CLEAR OUT DRUG FROM THE CATHETER PIECE, 72.1 CM WAS ADDED TO THE IMPLANTED SPINAL SEGMENT. THE PUMP WAS USED TO DELIVER BACLOFEN. THE TOTAL PRIME VOLUME WAS TO BE 0.358 ML AND THE PRIME BOLUS WAS 358 MCG (PUMP WAS TO BE PROGRAMMED WITH A DRUG CONCENTRATION OF 1000 MCG/ML AND A DAILY DOSE OF 50 MCG/DAY). THE DOSING REGIMEN PRIOR TO THE REVISION WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MANUFACTURING 8709 J10881R48

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| LOT# NGV010677N| IMPLANTABLE INFUSION PUMP MODEL 863740