BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1209879 · Received October 22, 2008

    Report

    Report Number
    2182207-2008-06761
    Event Type
    Injury
    Date Received
    October 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: OTHER= CATHETER. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: JHAS S, TULI S. INTRATHECAL CATHETER-TIP INFLAMMATORY MASSES: AN INTRAPARENCHYMAL GRANULOMA. J NEUROSURG SPINE. 2008; 9(2): 196-199. THE AUTHORS REPORT THE CASE OF A WOMAN WHO PRESENTED WITH AN INTRAPARENCHYMAL GRANULOMA IN HER LOWER THORACIC SPINAL CORD. ON IMAGING STUDIES, THERE WAS AN INTRAMEDULLARY ENHANCEMENT AT THE LEFT DORSAL ASPECT OF THE CORD IMMEDIATELY ADJACENT TO THE TIP OF AN INTRATHECAL ARACHNOID CATHETER USED FOR INTRASPINAL DRUG THERAPY. THERE WAS A GRANULOMATOUS COMPONENT THAT EXTENDED INTO THE SPINAL CORD. A 5-MM CASEATING CHALKLIKE GRANULOMA WAS CAREFULLY DISSECTED AWAY. THE CONCENTRATION OF MORPHINE AND THE DAILY DOSE SEEM TO CONTRIBUTE TO THE FORMATION OF CATHETER-TIP GRANULOMAS. TO THE AUTHORS' KNOWLEDGE, THIS IS THE FIRST REPORTED CASE OF AN INTRATHECAL CATHETER-TIP GRANULOMA GROWING INSIDE THE SPINAL CORD PARENCHYMA. REPORTABLE EVENT: WHEN THE PT PRESENTED TO THE EMERGENCY DEPARTMENT, SHE HAD HAD PROGRESSIVE LOWER EXTREMITY WEAKNESS OVER A 2- TO 3-YEAR PERIOD, MARKEDLY WORSE OVER THE PREVIOUS 3 WEEKS WITH LEFT LEG WEAKNESS AND A 2-DAY HISTORY OF URINARY INCONTINENCE. THORACIC SPINE MR IMAGING REVEALED A TZ WEIGHTED FOCAL INTRAMEDULLARY ENHANCEMENT AT THE LEFT DORSAL ASPECT OF THE CORD IMMEDIATELY ADJACENT TO THE TIP OF THE ARACHNOID CATHETER. THE MASS MEASURED ABOUT 5 MM IN DIAMETER AND WAS SURROUNDED BY EDEMA EXTENDING CEPHALAD TO THE MID T-8 LEVEL AND CAUDAL TO THE LEVEL OF T12-L1. AFTER REMOVAL HER PAIN WAS WELL MANAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LKK MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other PROGRAMMER MODEL UNK N=1| CATHETER MODEL UNK N=1