BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3725777 · Received April 3, 2014

    Report

    Report Number
    1723170-2014-00338
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    March 1, 2004
    Report Date
    March 4, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WAS UNAVAILABLE FROM THE LITERATURE ARTICLE. EVENT DATE IS APPROXIMATED FROM THE DETAILS IN THE LITERATURE. THERE WAS INSUFFICIENT INFORMATION IN THE ARTICLE TO PERFORM A FULL INVESTIGATION AND DETERMINE THE ROOT CAUSE OF THE REPORTED CATHETER MALPOSITION. ADDITIONALLY, PER THE ARTICLE, THE AUTHOR SUSPECTS THAT THE DILATION OF THE TRACT AND ELEVATED ICP CONTRIBUTED TO THE CATHETER MALPOSITION. NO INFORMATION HAS BEEN RECEIVED FROM THE AUTHORS FOR EVALUATION. JOURNAL ARTICLE: TAKAHASHI. NAVIGATION-GUIDED OMMAYA RESERVOIR PLACEMENT: IMPLICATIONS FOR THE TREATMENT OF LEPTOMENINGEAL METASTASES. M. TAKAHASHI , R. YAMADA , Y. TABEI , O. NAKAMURA , N. SHINOURA. AFFILIATION DEPARTMENT OF NEUROSURGERY, KOMAGOME METROPOLITAN HOSPITAL, BUNKYO-KU, TOKYO, JAPAN. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED MALPOSITION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN ADVERSE EVENT IDENTIFIED DURING A LITERATURE REVIEW PERFORMED ON APPROXIMATELY 03/01/2004. IDENTIFIED IN JOURNAL ARTICLE: TAKAHASHI BETWEEN MARCH 2004 AND DECEMBER 2005, 85 NAVIGATION-GUIDED OMMAYA RESERVOIR PLACEMENTS WERE PERFORMED IN 77 PATIENTS (AGE RANGE: 17 - 79 YEARS, AVERAGE: 58.9 YEARS) WITH INTRACRANIAL MALIGNANCIES AT THE KOMAGOME METROPOLITAN HOSPITAL. IN 84 OF 85 PROCEDURES, COMPUTED TOMOGRAPHY (CT) SCANS TAKEN IMMEDIATELY AFTER THE OPERATION REVEALED APPROPRIATE CATHETER POSITIONING AND ALL SIDE HOLES INSIDE THE LATERAL VENTRICLE. CATHETER MALPOSITION WAS OBSERVED IN ONE CASE IN WHICH REVISION OF THE APPARATUS WAS REQUIRED BECAUSE OF A SUBCUTANEOUS FLUID COLLECTION CAUSED BY THE PROGRESSION OF AN ANAPLASTIC OLIGOASTROCYTOMA FOUR MONTHS AFTER INITIAL TUMOR RESECTION. THIS TRANSLATED TO A COMPLICATION RATE OF ONLY 1.2 % . INTRACRANIAL HEMORRHAGE, INCLUDING SUBDURAL HEMATOMAS, INTRAVENTRICULAR HEMORRHAGE, AND SUBARACHNOID HEMORRHAGE, DID NOT OCCUR, AND NONE OF THE PATIENTS EXPERIENCED CSF INFECTION. CATHETER MALPOSITION OCCURS IN 2.7 - 12.5 % OF OMMAYA RESERVOIR PLACEMENT PROCEDURES [4, 10, 17, 22] . IN THE PRESENT STUDY, CATHETER MALPOSITION OCCURRED IN ONLY ONE CASE IN WHICH REVISION OF THE RESERVOIR WAS REQUIRED SECONDARY TO DEVELOPMENT OF A SUBCUTANEOUS FLUID COLLECTION WITH TUMOR PROGRESSION (ANAPLASTIC OLIGOASTROCYTOMA) FOLLOWING CHEMOTHERAPY AND RESERVOIR PLACEMENT FOUR MONTHS EARLIER. A NEW CATHETER WAS PLACED USING THE SAME TRAJECTORY AS THAT USED FOR THE INITIAL RESERVOIR, BUT POSTOPERATIVE CT DEMONSTRATED CATHETER MALPOSITION IN SPITE OF THE FACT THAT SMOOTH CSF FLOW WAS OBTAINED INTRAOPERATIVELY. EVEN SO, THE PATIENT SUFFERED NO NEUROLOGICAL CONSEQUENCES AND REMAINS UNDER OBSERVATION. WE SPECULATE THAT DILATION OF THE TRACT AND ELEVATED ICP MAY HAVE RESULTED IN CATHETER MALPOSITION IN THIS PATIENT. THUS, WE ADVOCATE THE CREATION OF A NEW TRACT IF CATHETER REVISION IS REQUIRED. NAVIGATION-GUIDED OMMAYA RESERVOIR PLACEMENT: IMPLICATIONS FOR THE TREATMENT OF LEPTOMENINGEAL METASTASES. M. TAKAHASHI , R. YAMADA , Y. TABEI , O. NAKAMURA , N. SHINOURA. AFFILIATION DEPARTMENT OF NEUROSURGERY, KOMAGOME METROPOLITAN HOSPITAL, BUNKYO-KU, TOKYO, JAPAN. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED MALPOSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201058 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention