BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1052742 · Received May 23, 2008

    Report

    Report Number
    2182207-2008-02795
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A CATHETER ACCESS PORT (CAP) PROCEDURE, THEY HAD DIFFICULTY ASPIRATING FLUID THROUGH THE CAP. THE PT WAS GOING TO BE BROUGHT BACK TO THE OFFICE FOR ANOTHER ATTEMPT TO ASPIRATE THE CATHETER. NO DEVICE TROUBLESHOOTING WAS DONE. THE PT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WAS NOT REPORTED; THE MFR'S DEVICE TRACKING SYSTEM INDICATES BACLOFEN. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC NEUROMODULATION 8709SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTABLE INFUSION PUMP MODEL 863720| EXPLANTED| LOT# NGP313150H| PROGRAMMER MODEL 8840