BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1029159 · Received April 14, 2008

    Report

    Report Number
    2182207-2008-01987
    Event Type
    Injury
    Date Received
    April 14, 2008
    Report Date
    April 2, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REF: MAGILL ST, WANT P, ELLER JL, BURCHIEL KJ. "DIFFERENTIATING INTRATHECAL CATHETER TIP GRANULOMAS FROM NORMAL MAGNETIC RESONANCE IMAGE DISTORTION CAUSED BY METALLIC CATHETER TIPS. "NEUROSURGERY 2008;62(1): 242-248. THE ARTICLE OBJECTIVE IS TO CHARACTERIZE THE NORMAL IMAGE DISTORTION PRODUCED BY METALLIC INTRATHECAL CATHETER TIPS AND DEFINE FEATURES THAT DIFFERENTIATE THEM FROM A CATHETER TIP GRANULOMA. THREE MEDTRONIC INC. INTRATHECAL CATHETER MODEL (M8709, M8711, AND M8731) WERE PLACED IN A WATER-FILLED PHANTOM, WHICH WAS SECURED WITH A SPINAL COIL AND SCANNED WITH A 1.5-T MAGNETIC RESONANCE IMAGING (MRI) SCANNER. MRI SCANS FROM TWO PATIENTS RECEIVING INTRATHECAL OPIATE THERAPY WITHOUT A GRANULOMA AND ONE PT WITH A GRANULOMA WERE ANALYZED FOR COMPARISON. IT WAS NOT CLEAR WHICH MODEL THE PT WITH THE GRANULOMA HAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R PROGRAMMER MODEL UNK| IMPLANTABLE INFUSION PUMP MODEL UNK