BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK VENTRICLEAR II CATHETER

    MDR report key: 3844650 · Received May 20, 2014

    Report

    Report Number
    2021898-2014-00160
    Event Type
    Other
    Date Received
    May 20, 2014
    Date of Event
    January 10, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS DISCOVERED BY MEDTRONIC NEUROSURGERY IN A REVIEW OF JOURNAL ARTICLE "HEMORRHAGIC COMPLICATIONS OF VENTRICULOSTOMY: INCIDENCE AND PREDICTORS IN PTS WITH INTRACEREBRAL HEMORRHAGE" THAT A VENTRICLEAR II CATHETER (3.0 MM DIAMETER) OR AN UNK LARGER-DIAMETER "TRAUMA" CATHETER (4.9 MM DIAMETER) WAS PLACED IN 69 PTS. TWENTY-TWO PTS HAD POST-VENTRICULOSTOMY HEMORRHAGE. NINETEEN OF THE 22 PTS HAD INTRAPARENCHYMAL HEMORRHAGING, 3 HAD SUBARACHNOID HEMORRHAGING, AND 1 HAD SUBDURAL HEMORRHAGING. ONE PT EXPERIENCED SIMULTANEOUS INTRAPARENCHYMAL AND SUBDURAL HEMORRHAGES, AND 1 PT HAD BOTH INTRAPARENCHYMAL AND SUBARACHNOID HEMORRHAGES. THE MAJORITY OF BLEEDS WERE SMALL AND SUBCLINICAL. ONLY ONE PT HAD A CLINICALLY SIGNIFICANT EPIDURAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299259 UNK VENTRICLEAR II CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other