BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5693638 · Received June 1, 2016

    Report

    Report Number
    1723170-2016-01040
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    October 31, 2014
    Report Date
    June 23, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDS AND WEIGHTS WERE REQUESTED FROM THE AUTHOR, BUT NOT RECEIVED. CITATION: LEE DJ, ZWIENENBERG-LEE, M, SEYAL M, SHAHLAIE K. INTRAOPERATIVE COMPUTED TOMOGRAPHY FOR INTRACRANIAL ELECTRODE IMPLANTATION SURGERY IN MEDICALLY REFRACTORY EPILEPSY. J NEUROSURG. 2015; 122: 526¿531. DOI: 10.3171/2014.9.JNS13919. DEPTH ELECTRODES ARE OFTEN PLACED WITH A HIGH DEGREE OF ACCURACY USING STEREOTACTIC GUIDANCE BUT CAN OCCASIONALLY BE MALPOSITIONED AS A RESULT OF ERRORS IN DEPTH PLACEMENT AND/OR LEAD DEVIATION. SUBDURAL GRID AND STRIP ELECTRODES ARE MORE PRONE TO SUBOPTIMAL POSITIONING SINCE THEY ARE SOMETIMES PASSED THROUGH A BUR HOLE OR BEYOND CRANIOTOMY EDGES. 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. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO MALFUNCTION IS ALLEGED, THEREFORE NO DEVICE EVALUATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY A CROSS-FUNCTIONAL ENGINEERING TEAM WHO DETERMINED: THE USE OF THE "BRAIN BIOPSY MODULE" FOR "ELECTRODE PLANNING" AS REPORTED IN THE JOURNAL ARTICLE IS OFF-LABEL USE OF THE BIOPSY APPLICATION. THE "CRANIAL SOFTWARE PACKAGE" ON THE NAVIGATION SYSTEM INCLUDES SOFTWARE FOR ELECTRODE AND PROBE PLACEMENT PROCEDURES. THE JOURNAL ARTICLE CONCLUDED: THE O-ARM CAN BE EASILY INCORPORATED INTO STANDARD FRAME-BASED AND FRAMELESS DBS SURGERY WITH SIMPLE TECHNICAL MODIFICATIONS. THIS IMAGING TECHNIQUE HAS BEEN SHOWN TO PROVIDE ACCURATE DEPICTIONS OF LEAD LOCATIONS AND HAS THE POTENTIAL TO REDUCE THE NUMBER OF MALPOSITIONED DBS ELECTRODES THAT MIGHT REQUIRE SUBSEQUENT REVISION SURGERY.

    Description of Event or Problem · 1

    IN THEIR ARTICLE ENTITLED, INTRAOPERATIVE COMPUTED TOMOGRAPHY FOR INTRACRANIAL ELECTRODE IMPLANTATION SURGERY IN MEDICALLY REFRACTORY EPILEPSY, LEE, ZWIENENBERG-LEE, SEYAL, & SHAHLAIEIN WRITE THAT IN THIS RETROSPECTIVE STUDY, THEY EVALUATED 10 CONSECUTIVE PATIENTS WHO HAD UNDERGONE SUBDURAL AND/OR DEPTH ELECTRODE IMPLANTATION FOR EPILEPSY MONITORING BETWEEN NOVEMBER 2010 AND SEPTEMBER 2012. THE PATIENT SERIES INCLUDED 6 WOMEN AND 4 MEN, WITH AN AVERAGE AGE OF (B)(6) YEARS. ALL PATIENTS UNDERWENT PLACEMENT OF SUBDURAL ELECTRODES (STRIPS AND/OR GRIDS), AND 8 OF THE 10 PATIENTS HAD MESIAL TEMPORAL LOBE DEPTH ELECTRODES PLACED AS WELL (TABLE 1). THE STEALTHSTATION CRANIAL SOFTWARE PACKAGE (MEDTRONIC INC.) IS USED, WITH THE BRAIN BIOPSY MODULE SELECTED FOR ELECTRODE PLANNING. SURGICAL PLANS ARE DEVELOPED FOR SUBDURAL ELECTRODE PLACEMENT. PLACED IN 10 PATIENTS USING ICT CONFIRMATION; THE SERIES INCLUDED 45 TEMPORAL LOBE STRIPS, 48 FRONTAL LOBE STRIPS, AND 11 GRID ARRAYS. FOUR STRIPS WERE REPLACED BECAUSE OF SUBOPTIMAL POSITIONING, INCLUDING 1 ANTERIOR TEMPORAL AND 3 INFERIOR/VENTRAL TEMPORAL STRIPS. THIRTY DEPTH ELECTRODES WERE PLACED IN 8 OF THE 10 PATIENTS USING ICT TO CONFIRM FINAL IMPLANTATION. POSTOPERATIVE CT SCANS WERE ALSO OBTAINED IN THE FIRST 3 PATIENTS IN THIS SERIES AND WERE IDENTICAL TO THE ICT SCANS WITH RESPECT TO ELECTRODE LEAD LOCATIONS. ONE DEPTH ELECTRODE WAS REPLACED BECAUSE OF SUBOPTIMAL POSITIONING OF THE ELECTRODE TIP, WHICH WAS POSTERIOR AND LATERAL TO THE INTENDED HIPPOCAMPAL TARGET. THERE WERE NO SURGICAL SITE INFECTIONS IN THIS CLINICAL SERIES. IN CASES IN WHICH ELECTRODE REPOSITIONING WAS PERFORMED, THE OPERATIVE TIME WAS PROLONGED APPROXIMATELY 12 MINUTES TO REPOSITION ELECTRODES AND CONFIRM FINAL LOCATION WITH A REPEAT ICT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345000 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention