BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1041236 · Received May 9, 2008

    Report

    Report Number
    6000030-2008-02498
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 9, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS CRACKED OUTSIDE THE INTRATHECAL SPACE, SO THE PATIENT DID NOT RECEIVE THE BOLUS IN THE INTRATHECAL SPACE. THE CATHETER WAS REVISED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WAS NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 J12477R04

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PUMP MODEL 863720 LOT# NGP012781N| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN