BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDM CATHETER

    MDR report key: 1910418 · Received November 18, 2010

    Report

    Report Number
    2021898-2010-00298
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    December 1, 2009
    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
    UK
    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 INFO. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFO ON INDIVIDUAL EVENTS. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFO PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE DESCRIBED FAILURE RATES WERE WITHIN EXPECTED RANGES FOR EVD PROCEDURES. TOMA AK, CAMP S, ET AL. EXTERNAL VENTRICULAR DRAIN INSPECTION ACCURACY: IS THERE A NEED FOR CHANGE IN PRACTICE?. NEUROSURGERY 2009 DECEMBER; VOL.6, NO. 6:1197-1201.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A STUDY THAT REVIEWED 183 POST-EVD INSERTION SCANS, WHERE MEDTRONIC EDM CATHETERS AND COMPETITOR CATHETERS WERE USED. THE SOURCE LITERATURE REPORTED THAT A TOTAL OF 62 PTS REQUIRED EVD REVISION OR REINSERTION PROCEDURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R