BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGLIDE

    MDR report key: 2973701 · Received February 21, 2013

    Report

    Report Number
    2973701
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY INC
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CT SCAN OF THE PATIENT'S HEAD WAS OBTAINED TO EVALUATE HIS ABNORMAL HEAD SHAPE AND HE WAS FOUND TO HAVE A DISCONNECTION OF HIS VENTRICULAR CATHETER FROM HIS SNAP TOP ASSEMBLY. IN FACT, THERE HAD BEEN BONE GROWING IN BETWEEN THE CATHETER AND THE CAP OF THE SNAP TOP ASSEMBLY. THE PATIENT DID NOT EXHIBIT ANY SIGNS OR SYMPTOMS OF INCREASED INTRACRANIAL PRESSURE. HOWEVER, OPHTHALMOLOGIST EXAMINATION REVEALED THE PRESENCE OF PAPILLEDEMA.======================MANUFACTURER RESPONSE FOR SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS, BIOGLIDE VENTRICULAR CATHETER (PER SITE REPORTER).======================THE MANUFACTURER IS AWARE OF THIS PROBLEM AND HAS ISSUED A RECALL ON THIS BIOGLIDE CATHETER, (FDA RECALL #'S Z-1124-2009 TO Z-1134-2009).WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VENTRTICULAR SHUNT FOR HYDROCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76556 BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG MEDTRONIC NEUROSURGERY INC * C14789

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR