BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1032793 · Received April 23, 2008

    Report

    Report Number
    6000030-2008-02167
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    January 15, 2008
    Report Date
    March 26, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED WITHDRAWAL FROM SPINAL OPIOID; THE SYMPTOMS WERE NOT SPECIFIED. THE HCP ATTEMPTED TO ASPIRATE FROM THE SIDE PORT AND WAS UNSUCCESSFUL; THE CATHETER WAS OCCLUDED. THE DISTAL PORTION OF THE CATHETER WAS REVISED. THE PT OUTCOME WAS REPORTED AS "ONGOING" AS THE PT WAS HAVING DIFFICULTY WITH A CSF LEAK, BUT IT WAS RESOLVING. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WAS NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8731 N002266719

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANTED| LOT# NGP013235N| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863720