BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARES ANTIBIOTIC-IMPREGNATED CATHETER KIT

    MDR report key: 3080739 · Received April 9, 2013

    Report

    Report Number
    3080739
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTORNIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY IN USER FACILITY MEDWATCH REPORT (B)(4) THAT A (B)(6) MALE UNDER WENT AN INSERTION OF A VENTRICULOPERITONEAL SHUNT ON (B)(6) 2013. POSTOPERATIVELY, IT WAS NOTED THAT HE HAD A DISTENDED ABDOMEN. POSTOPERATIVE SHUNT IMAGING SHOWED SOME GAS WITHIN THE COLON, HOWEVER, THE SHUNT TUBING WAS NOTED TO BE COILED WITHOUT ANY SIGNS OF MALPOSITION. HOWEVER, HE CONTINUED TO HAVE THE ABDOMINAL DISTENTION AND WAS MADE NPO. PER DISCUSSION WITH THE FAMILY, HE WAS NOTED TO BE A GASSY CHILD, THEREFORE HE WAS STARTED ON SUPPOSITORIES AND SIMETHICONE DROPS. AFTER HAVING A BOWEL MOVEMENT, IT WAS NOTED THAT THERE WAS SHUNT TUBING EXITING FROM THE RECTUM. EXTERNALIZATION OF THE SHUNT OCCURRED ON (B)(6) 2013; IN ADDITION IT WAS NOTED TUBING WAS NOTED ENTERING THE TRANSVERSE COLON - THIS WAS DIVIDED AND THE REMAINDER REMOVED THROUGH THE RECTUM. THE COLON WAS REPAIRED. ON (B)(6) 2013, REMOVAL THROUGH THE RECTUM. THE COLON WAS REPAIRED. ON (B)(6) 2013, REMOVAL OF EXTERNAL VENTRICULAR DRAIN OCCURRED AND PLACEMENT OF NEW INTERNALIZED VENTRICULAR DRAIN PLACE. PT DID WELL, REMAINED HEMODYNAMICALLY STABLE WITHOUT SIGNS OF INFECTION AND WAS DISCHARGED TO HOME ON (B)(6) 2013. PLEASE REFER MFR# 2021898-2013-00134.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144768 ARES ANTIBIOTIC-IMPREGNATED CATHETER KIT JXG - SHUNG, CENTRAL NERVOUS SYSTEM ADN COMPOENNTS JXG MEDTORNIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Hospitalization| R