BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1003437 · Received February 21, 2008

    Report

    Report Number
    6000030-2008-00844
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Report Date
    January 22, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE CATHETER WAS KINKED AND WOULD BE REVISED IN 2008. DEVICE REGISTRATION SYSTEM INDICATES THE CATHETER WAS REPLACED. NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8703 J91085408

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT# NGV408089H| EXPLANTED:| IMPLANTABLE INFUSION PUMP