BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSV II TWO PIECE SYSTEM WITH ANTECHAMBER

    MDR report key: 533360 · Received March 11, 2004

    Report

    Report Number
    9612007-2004-00015
    Event Type
    Malfunction
    Date Received
    March 11, 2004
    Report Date
    March 11, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT A PT DIAGNOSED WITH NPH (NORMAL PRESSURE HYDROCEPHALUS) AND HAD AN OSVII VALVE IMPLANTED IN 2004. INITIALLY IMPROVED CONDITION, AND THEN SYMPTOMS APPEARED SUCH AS HEADACHES, SEIZURES, VENTRICLES DECREASED IN SIZE, AND A SUBDURAL HEMATOMA. DR. REPLACED THE OSVII WITH A CODMAN PROGRAMMABLE VALVE. HIS OBSERVATION OF THE VALVE IS THAT IT IS HYPERFUNCTIONING AND OVERDRAINING CSF. UPON REMOVAL THE FLUID FLOWED FREELY AND THERE IS NO EVIDENCE OF OBSTRUCTION. THE PT REQUIRED THE VALVE REVISION TO CORRECT THE SYMPTOMS. THE PT IS NOW DISCHARGED WITH AN IMPROVED NEUROLOGICAL STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSV II TWO PIECE SYSTEM WITH ANTECHAMBER OSV II JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * 123415

    Patients

    Seq Age Sex Outcome Treatment
    1 *