BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 7986376 · Received October 19, 2018

    Report

    Report Number
    1226348-2018-10742
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    November 11, 2017
    Report Date
    October 1, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE HAVE NOT BEEN SUCCESSFUL. 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 ¿CHRONIC OVERDRAINAGE SYNDROME: PATHOPHYSIOLOGICAL INSIGHTS BASED ON ICP ANALYSIS: A CASE-BASED REVIEW¿ BY LAURA V. SAINZ & KONSTANTIN HOCKEL & MARTIN U. SCHUHMANN, PUBLISHED CHILDS NERV SYST (2018) 34:401¿408, HTTPS://DOI.ORG/10.1007/S00381-017-3650-4, IT WAS REPORTED THAT IMPLANT OF AN UNKNOWN HAKIM PROGRAMMABLE VALVE WITHOUT SIPHONGUARD, THE PATIENT HAD OVERDRAINAGE SYNDROME THAT RESULTED IN DEVICE REVISION. PER THE ARTICLE: ¿IN THIS REPORT, WE PRESENT THE CASE OF A YOUNG WOMEN, SHUNTED SINCE THE POSTNATAL PERIOD, WHO SUFFERED THE MOST SEVERE DISABLING HEADACHE ATTACKS DESPITE AN OPEN SHUNT AND UNCHANGED VENTRICLES. ICP RECORDING WAS PERFORMED DURING A HEADACHE ATTACK AND THE FOLLOWING 36 H. A SHUNT REVISION WAS PERFORMED, AND A NEW ADJUSTABLE VALVE PLUS AN ADJUSTABLE GRAVITATIONAL UNIT WAS PLACED. THE CLINICAL PICTURE, THE ICP RECORDINGS, AND THE MANAGEMENT OF OPERATING PRESSURES OF THE VALVE TO MAKE THE HEADACHE ATTACKS DISAPPEAR ARE BEST EXPLAINED BY ABNORMAL DYNAMICS OF CHRONICALLY DISTENDED CEREBRAL VEINS, AS A CONSEQUENCE OF CHRONIC CEREBROSPINAL FLUID (CSF) OVERDRAINAGE.¿ IT WAS REPORTED THAT THIS IS A (B)(6) WOMAN WHO RECEIVED THE VALVE IN THE POST-NATAL PERIOD WHO EXPERIENCED DISABLING HEADACHES IN CONJUNCTION WITH CHRONIC OVER DRAINAGE SYNDROME. 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
    826726 NI SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other