BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE PROGRAMMABLE CHPV (823113)

    MDR report key: 14117920 · Received April 14, 2022

    Report

    Report Number
    MW5109023
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    July 13, 2018
    Report Date
    April 13, 2022
    Manufacturer
    J&J CODMAN INSTRUMENT DIV / CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    VP SHUNT IMPLANTED (B)(6) 2018. SHUNT MALFUNCTION 3 WKS LATER. HEAD BEGIN BLEEDING. SHUNT CAUSED 1ST BRAIN BLEED, EMERGENCY CARE RECEIVED; 7 DAYS LATER 2ND BRAIN BLEED. THIS ONE CRITICAL. TUBING IN MY THROAT WAS SLIT TO SHUT OFF SHUNT. SHUNT WOULD TURN ON AND BACK ON HIGH BY ITSELF. I COULD HEAR IT HUMMING. I AM LEFT WITH MORE SEVERE HEADACHES THEN BEFORE. VISION LOSS, CAN'T DRIVE AT NIGHT. NO PERIPHERAL VISION. I HAVE TO SEE A THERAPIST MONTHLY DUE TO ANXIETY ISSUES. I WILL BE ON FLUID DRAINING MEDS, ANXIETY MEDS AND HEADACHE MEDS THE REST OF MY LIFE. I WORK FOR THE FIRE DEPT BUT CAN'T APPLY FOR PROMOTION BECAUSE I CAN'T TAKE CLASSES DUE TO BEING UNABLE TO RETAIN NEW INFORMATION. I HAVE BEEN ON FMLA EVERY YEAR SINCE THE SURGERY. SOME DAYS THE PAIN IS TO BAD TO GET OUT OF BED. RAIN AFFECTS IT REALLY BAD. RAIN WAS NOT AN ISSUE BEFORE THE SHUNT WAS IMPLANTED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974437 VALVE PROGRAMMABLE CHPV (823113) SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG J&J CODMAN INSTRUMENT DIV / CODMAN & SHURTLEFF, INC. 171548

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| L| S| H ACETAZOLAMIDE ER 500 MG| DULOXETINE 40 MG| ONDANSETRON OFT 4 MG| PROMETHAZINE 12.5 MG| TOPRIMATE 25 MG