BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 8005954 · Received October 25, 2018

    Report

    Report Number
    1226348-2018-10753
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    January 20, 2017
    Report Date
    October 2, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. 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 ¿OBSTRUCTIVE HYDROCEPHALUS CAUSED BY AN UNRUPTURED ARTERIOVENOUS MALFORMATION SUCCESSFULLY TREATED BY ENDOSCOPIC THIRD VENTRICULOSTOMY AFTER SHUNT DYSFUNCTION¿ BY CHARLES CHAMPEAUX, CÉLINE BOTELLA, ETIENNE LEFEVRE, BERTRAND DEVAUZ, PUBLISHED TURK NEUROSURG 28 (3): 500-504, 2018, DOI: 10.5137/1019-5149.JTN.19435-16.2, IT WAS REPORTED THAT 2 YEARS AFTER IMPLANT OF AN UNKNOWN HAKIM PROGRAMMABLE VALVE, THERE WAS OBSTRUCTION OF THE DISTAL CATHETER WITH HYDROCEPHALUS SYMPTOMS AND SUSPECTED INFECTION; THEREFORE, THE DEVICE WAS REVISED AND THE PATIENT TREATED WITH ANTIBIOTICS. PER THE ARTICLE: ¿TWO YEARS LATER, HE PRESENTED TO THE LOCAL MEDICAL EMERGENCY UNIT FOLLOWING A FALL AND COMPLAINING OF DROWSINESS, ABDOMINAL PAIN AND INCONTINENCE. C-REACTIVE PROTEIN (CRP) WAS 89 MG/L. THE BODY CT SCAN SHOWED A MINOR COMPRESSION-FRACTURE OF THE SUPERIOR PLATE OF L2, A SUBHEPATIC COLLECTION SURROUNDING THE DISTAL END OF THE PERITONEAL CATHETER, AND ACUTE HYDROCEPHALUS. HE WAS SUBSEQUENTLY TRANSFERRED TO OUR DEPARTMENT. A NEW SHUNT DYSFUNCTION WAS ASCERTAINED POSSIBLY ASSOCIATED WITH AN INFECTION OF THE VALVE¿ THE LEFT LATERAL VENTRICLE WAS WASHED UNTIL THE CEREBROSPINAL FLUID (CSF) BECAME CLEAR AND THE SYSTEM REMOVED. A STANDARD CLOSURE WAS ACHIEVED. THE RIGHT VP SHUNT WAS ENTIRELY EXTRACTED AND SENT FOR MICROBIOLOGY ANALYSIS. 20 ML OF CSF WAS REMOVED THROUGH A LUMBAR PUNCTURE TO INITIATE THE FLOW THROUGH THE VENTRICULOSTOMY AND ALSO SENT FOR MICROBIOLOGICAL ANALYSIS¿THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND HE WAS DISCHARGED 7 DAYS AFTER THE PROCEDURE. THE VENTRICULAR CATHETER CULTURE GREW SOME COLONIES OF STAPHYLOCOCCUS WARNERI, BUT THE SHUNT WAS NOT PROVEN TO BE INFECTED. HE WAS TREATED 14 DAYS ORALLY BY AMOXICILLIN WITH CLAVULANIC ACID.¿ 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
    847154 NI SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1