BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 211605 · Received February 12, 1999

    Report

    Report Number
    211605
    Event Type
    Death
    Date Received
    February 12, 1999
    Date of Event
    January 28, 1999
    Report Date
    February 10, 1999
    Manufacturer
    UNK
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE ED WITH SEIZURES ON 1/18. PATIENT HAD A VENTRICULOPERITONEAL SHUNT WHICH WAS PLACED APPROX 11 YEARS AGO IN ANOTHER COUNTRY DUE TO A HISTORY OF HYDROCEPHALUS. HE REPORTEDLY STARTED HAVING SEIZURES 3 DAYS AFTER THE VP SHUNT WAS PLACED. SINCE THEN HE HAS SUFFERED APPROX 1 SEIZURE PER YEAR WITH THE MOST RECENT IN AUG. 1998. DR. FELT THAT SHUNT FAILURE WAS POSSIBLY CONTRIBUTING TO THE SEIZURES. REPLACEMENT SURGERY ON 1/28/99. PATIENT TOLERATED REPLACEMENT SURGERY "AS MUCH AS POSSIBLE". PATIENT WAS THEN ADMITTED TO HOSPICE CARE. PATIENT DIED 2/5/1999 AT 2110 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant VENTRICULOPERITONEAL SHUNT JXG UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death