BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE

    MDR report key: 3211176 · Received July 8, 2013

    Report

    Report Number
    1226348-2013-20637
    Event Type
    Injury
    Date Received
    July 8, 2013
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. (B)(4).

    Description of Event or Problem · 1

    CASE 1: AN (B)(6) HYPERTENSIVE WOMAN HAD A 10-MONTH HISTORY OF GAIT DISTURBANCE, DEMENTIA, AND URINARY INCONTINENCE. COMPUTED TOMOGRAPHY (CT) OF THE HEAD SHOWED MODERATELY ENLARGED LATERAL VENTRICLES WITH AN EVANS INDEX OF 31.4%. UNDER A DIAGNOSIS OF IDIOPATHIC NORMAL-PRESSURE HYDROCEPHALUS, A VP SHUNT WAS PLACED VIA A RIGHT FRONTAL HORN PUNCTURE. INTRAOPERATIVE BLEEDING FROM THE CORTICAL VEIN UNDER THE EXPOSED DURA WAS RELATIVELY STRONG, SO ANOTHER BURRHOLE WAS NEEDED FOR VENTRICULAR CATHETER CANNULATION. SHE EXPERIENCED GENERALIZED CONVULSION 4 HOURS AFTER THE OPERATION. HEAD CT SHOWED A 4.8 X 4.7 CM SUBCORTICAL HEMATOMA CLOSE TO THE VENTRICULAR CATHETER. WE DID NOT TREAT THE HEMATOMA SURGICALLY. T2-WEIGHTED MAGNETIC RESONANCE (MR) IMAGING BEFORE THE OPERATION SHOWED NO EVIDENT ORGANIC LESIONS SUCH AS VASCULAR MALFORMATION OR BRAIN TUMOR. T2-WEIGHTED MR IMAGING WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310867 UNKNOWN VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention