BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 1910390 · Received November 18, 2010

    Report

    Report Number
    2021898-2010-00306
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    December 1, 2007
    Report Date
    October 20, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THESE REPORTABLE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE AND PT INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFORMATION ON INDIVIDUAL EVENTS. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE DESCRIBED FAILURE RATES WERE WITHIN EXPECTED RANGES FOR CSF SHUNTING PROCEDURES. GREENFIELD JP, SCHWARTZ TH. CATHETER PLACEMENT FOR OMMAYA RESERVOIRS WITH FRAMELESS SURGICAL NAVIGATION: TECHNICAL NOTE. STEREOTACT FUNCT NEUROSURG 2008; 86: 101-105.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A STUDY OF 20 PTS THAT REC'D AN OMMAYA RESERVOIR WITH MEDTRONIC CATHETERS. THE SOURCE LITERATURE REPORTED THAT 2 PTS REQUIRED REVISIONS DUE TO INFECTION, AND ONE PT DEVELOPED A HEMORRHAGE ALONG THE CATHETER TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CATHETER JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R