BEUDAMED
    FDA Adverse Event Other Summary report: N

    HV LUMBAR VALVE SYS YELLOW, TALL CHILD/ADULTS

    MDR report key: 2111067 · Received May 24, 2011

    Report

    Report Number
    9612007-2011-00022
    Event Type
    Other
    Date Received
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    INTEGRA, BIOT
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION AT THIS TIME. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE FIRST LUMBOPERITONEAL (LP) SHUNT (MANUFACTURER UNSPECIFIED) IMPLANTED IN 1984 AND IT WORKED WELL UNTIL LATE LAST YEAR IN (B)(6) 2010 WHEN THE PATIENT BECAME SYMPTOMATIC WITH RAISED INTRACRANIAL PRESSURE (ICP). A JOHNSON & JOHNSON CODMAN VENTRICULOPERITONEAL (VP) PROGRAMMABLE HEAD SHUNT WAS PLACED IN (B)(6) 2010 WITH NO RELIEF OF SYMPTOMS OR DECREASE IN ICP. AN INTEGRA HORIZONTAL VERTICAL (HV) LUMBAR VALVE WAS IMPLANTED ON (B)(6) 2011 BUT SYMPTOMS PERSISTED AND THE PATIENT'S ICP REMAINED ELEVATED. THE CODMAN VALVE SETTING WAS CHANGED FROM 80 TO 50 BUT IT WORSENED THE PATIENT'S SYMPTOMS. THAT SETTING WAS RETURNED TO 80 AND THE PATIENT WAS ADMITTED ON (B)(6), 2011 FOR SHUNTOGRAMS SUGGESTED BY A CONSULTING PHYSICIAN. SHUNTOGRAMS DEMONSTRATED THAT ONLY 1 OF THE 3 SHUNTS FLOWED, THE INTEGRA HV LUMBAR SHUNT. THE INTEGRA HV LUMBAR VALVE IS WORKING BUT THE PATIENT'S HEADACHES WERE NOT GOING AWAY AND THE PRESSURE WAS STILL HIGH. THE PATIENT WAS STARTED ON TOPAMAX (TOPIRAMATE) AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011 WITH IMPROVED SYMPTOMS. ICP WAS NOT RETESTED. THE PATIENT STATED, HOWEVER, THAT HE WAS EXPERIENCING SIDE EFFECTS OF DIZZINESS, TIREDNESS, AND DIARRHEA FROM THE TOPAMAX. THE PATIENT WAS THEN TAKEN OFF OF THE TOPAMAX BECAUSE HIS PRESSURE CONTINUED TO BE HIGH. ON (B)(6) 2011, THE PATIENT WAS PRESCRIBED DIAMOX (ACETAZOLAMIDE) 1000 MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HV LUMBAR VALVE SYS YELLOW, TALL CHILD/ADULTS DP VALVE JXG INTEGRA, BIOT

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR