BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 970382 · Received December 27, 2007

    Report

    Report Number
    6000030-2007-04594
    Event Type
    Injury
    Date Received
    December 27, 2007
    Report Date
    November 28, 2007
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED, THAT SHE WAS EXPERIENCING AN INCREASE IN HER BASELINE PAIN. SHE ALSO REPORTED, THAT HER CATHETER WAS CONFIRMED TO BE FRACTURED IN 2007; HOWEVER, THE HCP HAD TOLD HER THAT TRYING TO RETRIEVE THE PIECE THAT HAD BROKEN OFF IN HER SPINE MAY BE TOO MUCH OF A RISK. THE PATIENT STATED, THAT HER PUMP WAS CURRENTLY TURNED OFF. THE HCP FURTHER REPORTED THAT THE PATIENT'S PUMP WAS USED TO DELIVER MORPHINE SULFATE. A MYELOGRAM WAS DONE IN 2006 AND REVEALED A "CATHETER FRAGMENT ENTERING THE SUBARACHNOID SPACE AT L1-2 LEVEL WITH THE TIP OF THE CATHETER EXTENDING SUPERIORLY WITH THE CONUS MEDULLARIS." THE HCP REPORTED, THE PATIENT OUTCOME AS "NON-SERIOUS ILLNESS" AND REPORTED THAT THE PATIENT WOULD TAKE UNSPECIFIED ORAL NARCOTIC PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8079 J0177975R

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNKNOWN| EXPLANTED| EXPLANTED| PUMP MODEL 8627L18