BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 689104 · Received March 15, 2006

    Report

    Report Number
    2182270-2006-00427
    Event Type
    Injury
    Date Received
    March 15, 2006
    Report Date
    March 8, 2006
    Manufacturer
    NEUROLOGICAL DEVCE, MEDTRONIC DIVISION
    Product Code
    ---
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SURGERY FOR RETRIEVAL OF THE RETAINED CATHETER FRAGMENT. THE PATIENT HAD UNDERGONE A TRIAL OF INTRATHECAL MORPHINE IN 2005. THE DOSE WAS TITRATED UP TO 25MG/DAY OF INTRATHECAL MORPHINE WITH A SIGNIFICANT DECREASE IN HER CHRONIC PAIN WITHOUT ANY SIDE EFFECTS. THE CATHETER FRACTURED UPON REMOVAL IN 2005. THE NEUROSURGEON NOTED THAT THE 'SPINOUS PROCESSES BETWEEN L.3 AND L.4 WERE VERY LARGE AND THEY BASICALLY TOUCHED ERACH OTHER AND IT WAS PROBABLY HER SPINOUS PROCESSES THAT JUST CAUSED THE COMPOROMISE OF THE CATHETER THAT LEAD TO ITS EVENTUAL FRACTURE'. THE CATEHTER FRAGMENT WAS REMOVED INTACT. "SHE HAS NO SEQUELA FROM THAT FRACTURED CATHETER". THE HCP PLANNED TO IMPLANT A PUMP IN 2006. NO FURTHER INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER --- NEUROLOGICAL DEVCE, MEDTRONIC DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization