BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 7739146 · Received August 1, 2018

    Report

    Report Number
    1226348-2018-10543
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    September 13, 2017
    Report Date
    July 10, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE "SYMPTOMATIC COMMUNICATING HYDROCEPHALUS IN A CONTEMPORARY COHORT OF HIGH GRADE GLIOMA PATIENTS" IT WAS REPORTED THAT ONE UNKNOWN PATIENT WHO RECEIVED AN UNKNOWN HAKIM PROGRAMMABLE VALVE HAD INFECTION POST OPERATIVELY. THERE ARE NO FURTHER DETAILS REGARDING THE INFECTION, DEVICE OR TREATMENT. PER THE ARTICLE: "HIGH GRADE GLIOMA (HGG) TREATMENT HAS SEEN A PARADIGM SHIFT WITH INTENSIFIED REGIMES, BUT HOSPITALIZATION BURDEN IS PARTIALLY ATTRIBUTED TO SIDE EFFECTS OF THERAPY. SYMPTOMATIC COMMUNICATING HYDROCEPHALUS (HC) IS A POTENTIAL COMPLICATION. AIM OF THIS STUDY WAS TO INVESTIGATE ITS INCIDENCE, RISK FACTORS AND TREATMENT IN A CONTEMPORARY COHORT." FURTHER, "TREATMENT AND OUTCOME OF GLIOMA PATIENTS WITH HC ALL AFFECTED PATIENTS WERE TREATED WITH VENTRICULOPERITONEAL SHUNTS, USING ADJUSTABLE DIFFERENTIAL PRESSURE VALVES. IMPROVEMENT OF SYMPTOMS WAS OBSERVED IN SEVEN PATIENTS, WHEREAS ONE PATIENT REMAINED UNCHANGED AFTER CSF DIVERSION. WITHIN 30 DAYS AFTER SHUNT IMPLANTATION THE MEAN EVANS' RATIO HAD DECREASED TO 0.32 ± 0.05. COMPLICATIONS WERE ENCOUNTERED IN ONE CASE, WHERE A SHUNT INFECTION OCCURRED TWO MONTHS AFTER IMPLANTATION. MEDIAN OVERALL SURVIVAL AFTER SHUNT IMPLANTATION WAS 4 MONTHS." AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580260 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R