BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBIS SIGMA VALVE

    MDR report key: 107789 · Received July 25, 1997

    Report

    Report Number
    9612007-1997-00015
    Event Type
    Injury
    Date Received
    July 25, 1997
    Date of Event
    May 27, 1997
    Report Date
    June 26, 1997
    Manufacturer
    ELEKTA IMPLANTS, SA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ORBIS SIGMA VALVE WAS IMPLANTED ON 5/25/1997 IN A 13 Y/O BOY. AS NO CLINICAL EFFECTIVENESS WAS OBSERVED (DROWSINESS, CT SCAN HYDROCEPHALUS SIGNS), THE PT WAS EXPLANTED ON 5/27/97. DURING REVISION, THE VALVE WAS TESTED AND FOUND NOT PATENT. THERE WAS NO REPORT OF INJURY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORBIS SIGMA VALVE Implant HYDROCEPHALUS VALVE JXG ELEKTA IMPLANTS, SA NA 20397066

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention