BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLEABLE SHUNT TUNNELERS

    MDR report key: 693571 · Received March 29, 2006

    Report

    Report Number
    9612007-2006-00010
    Event Type
    Malfunction
    Date Received
    March 29, 2006
    Report Date
    March 29, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    ---
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE SURGEON IMPLANTED THE DEVICE AND THE PT EXPERIENCED A HIGH FEVER WITHIN 12 HOURS. THE PT BECAME VERY ILL. CSF CULTURES WERE TAKEN AND NO BACTERIAL INFECTION WAS FOUND. STEROIDS WERE GIVEN. THE SHUNT IS STILL IN THE PT. A TUNNELER 990-010 WAS ALSO USED. THIS CURRENT MDR IS LINKED TO MDR# 9612007-2006-00009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLEABLE SHUNT TUNNELERS OSV II --- INTEGRA NEUROSCIENCES IMPLANTS S.A. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *