BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA CATHETER

    MDR report key: 1022765 · Received March 28, 2008

    Report

    Report Number
    6000030-2008-01673
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 19, 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

    IT WAS REPORTED THAT THE PT EXPERIENCED INCREASED SPASTICITY AND LACK OF EFFICACY DESPITE SEVERAL DOSE INCREASES UP TO 200 MCG/DAY. A CATHETER DYE STUDY WAS UNSUCCESSFUL SO THE PT WAS TAKEN TO THE OPERATING ROOM WHERE IT WAS FOUND THAT THE CATHETER WAS SHEARED. THE PATIENT'S CATHETER WAS REPLACED. FOLLOWING REPLACEMENT, THE HCP DID NOT WANT TO CHANGE THE DRUG CONCENTRATION, BUT THE PATIENT'S DOSE WAS DECREASED TO THE LOWEST POSSIBLE DOSE WITH THE 2000 MCG/ML CONCENTRATION (96 MCG/DAY). THE PATIENT WAS OBSERVED OVERNIGHT AND COMPLAINED OF SOME INCREASED FLACCID LEG SYMPTOMS. THE HCP PERFORMED A DRUG REMOVAL AND REPLACEMENT PROCEDURE TO DECREASE THE CONCENTRATION, AND THE DOSE WAS DECREASED TO 41 MCG/DAY. THE PT WAS DISCHARGED HOME AND RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MANUFACTURING 8709 L38028

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED:| IMPLANTED:| LOT# NGV004942N| EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 8637