BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL DRAINAGE SET

    MDR report key: 330271 · Received May 4, 2001

    Report

    Report Number
    9612007-2001-00018
    Event Type
    Injury
    Date Received
    May 4, 2001
    Date of Event
    January 14, 2001
    Report Date
    February 13, 2001
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT AN EXTERNAL DRAINAGE SET DID NOT ALLOW CEREBRO SPINAL FLUID TO DRAIN OUT OF PT'S HEAD RESULTING IN HIGH INTRACRANIAL PRESSURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20695 EXTERNAL DRAINAGE SET EXTERNAL DRAINAGE SETS JXG NMT NEUROSCIENCES IMPLANTS S.A. NA 70599550

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention