BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBIS SIGMA VALVE

    MDR report key: 167619 · Received May 15, 1998

    Report

    Report Number
    9612007-1998-00013
    Event Type
    Injury
    Date Received
    May 15, 1998
    Date of Event
    April 6, 1998
    Report Date
    April 23, 1998
    Manufacturer
    ELEKTA IMPLANTS SA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT FROM THE FIELD INDICATED THAT AN HYDROCEPHALUS PT WAS IMPLANTED WITH THE VALVE ON APRIL 4, 1996. ON SEPTEMBER 14, 1996, OVERDRAINAGE WAS NOTED. A COMPUTERIZED TOMOGRAPHY SCAN PERFORMED ON AUGUTST 21, 1996, BECAUSE OF SKIN INFECTION, AND REPLACED BY THE SAME VALVE MODEL, UNEVENTFULLY. THE DOCTOR REQUESTED A PRODUCT ANALYSIS TO DETERMINE THE CAUSE OF THE OVERDRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORBIS SIGMA VALVE Implant HYDROCEPHALUS SHUNT JXG ELEKTA IMPLANTS SA NA 20895132

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention