BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGLIDE

    MDR report key: 3021290 · Received March 21, 2013

    Report

    Report Number
    3021290
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY INC
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) IN VERY CRITICAL CONDITION WITH SIGNS AND SYMPTOMS (S/S) OF HERNIATION AND A CHANGE IN TYPICAL SEIZURE PATTERN WITH DECEREBRATE POSTURE. SHUNT WAS TAPPED URGENTLY TO STABILIZE HER, WITH 5 ML REMOVED AND SENT FOR CULTURE. CULTURE SHOWED GRAM NEGATIVE BACTERIA RODS. SHE WAS TAKEN TO THE OPERATING ROOM (OR) EMERGENTLY WHERE SHE UNDERWENT REMOVAL OF LEFT FRONTAL VENTRICULOPERITIONEAL (VP) SHUNT WITH INSERTION OF EXTERNAL VENTRICULAR DRAIN (EVD). SHE HAS INFECTION. ID CONSULTING. CURRENTLY IN PEDIATRIC INTENSIVE CARE UNIT (PICU).======================MANUFACTURER RESPONSE FOR SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS, BIOGLIDE VENTRICULAR CATHETER (PER SITE REPORTER).======================KNOWN ISSUE. RECALLED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VP SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117887 BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG MEDTRONIC NEUROSURGERY INC * C25040

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR