Case Report Template - V1

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

Participants

• Sales Rep

  Chris Kantorak

  Dan Schoenecker

  David Schwartz

  Joe Greenwald

  Mark Ballinger

• Clinical Support Lead

  Select Alaine Keebaugh Craig Walters Eddie Kelly Geoffrey Bates Shruti Gupta Tim Goble

  • Alaine Keebaugh
  • Craig Walters
  • Eddie Kelly
  • Geoffrey Bates
  • Shruti Gupta
  • Tim Goble

• Other MRI members

  Yes

  No

  N/A

General Information

• Date

  Date

• Scanner

  Siemens Magnetom

  Scanner 2

  Scanner 3

• Patient position

  Prone

  Supine

  Others

• Hospital

  Select Akon Baptist - Memphis Brainlab Brigham & Women Children Healthcare of Atlanta Cincinnati Children Hospital Cleveland Clinic Hospital Cook Children Medical Center Emory Healthcare Geisinger Glenbrook Hackensack Univ. Medical Center Henry Ford Health Sys Joan and Stanford Weill Medical College John Hopkins (Research) Lebonhuer (Memphis) Loyola Mayo MD Anderson Cancer Center Memorial Sloan-Kettering Cancer Center Methodist Hospital NBR Northwestern Memorial NY Psychiatric Institute Ohio State University Oregon Health & Science University Robert Wood Johnson Spectrum Swedish Thomas Jefferson Tocagen UCLA UCSD UCSF Medical Center UMASS Medical Center University of Colorado University of Utah University of Wisconsin UPMC UT San Antonio UVA VA - San Francisco Valley Biosystem, Inc. Wake Forest Willis Knighton Yale University

  • Akon
  • Baptist - Memphis
  • Brainlab
  • Brigham & Women
  • Children Healthcare of Atlanta
  • Cincinnati Children Hospital
  • Cleveland Clinic Hospital
  • Cook Children Medical Center
  • Emory Healthcare
  • Geisinger
  • Glenbrook
  • Hackensack Univ. Medical Center
  • Henry Ford Health Sys
  • Joan and Stanford Weill Medical College
  • John Hopkins (Research)
  • Lebonhuer (Memphis)
  • Loyola
  • Mayo
  • MD Anderson Cancer Center
  • Memorial Sloan-Kettering Cancer Center
  • Methodist Hospital
  • NBR
  • Northwestern Memorial
  • NY Psychiatric Institute
  • Ohio State University
  • Oregon Health & Science University
  • Robert Wood Johnson
  • Spectrum
  • Swedish
  • Thomas Jefferson
  • Tocagen
  • UCLA
  • UCSD
  • UCSF Medical Center
  • UMASS Medical Center
  • University of Colorado
  • University of Utah
  • University of Wisconsin
  • UPMC
  • UT San Antonio
  • UVA
  • VA - San Francisco
  • Valley Biosystem, Inc.
  • Wake Forest
  • Willis Knighton
  • Yale University

• Software Version

• Type of Procedure

• Surgeon

• MRI Tech

• Target

• Fellow(s)

• Uni or Bilateral

  Unilateral

  Bilateral

Procedure (If you want to add note for your answer, just double click on the border)

• Clearpoint product used

  Yes

  No

  N/A

• Is the Surgeon/Fellow trained to use product with completed -0079?

  Yes

  No

  N/A

• Is there a defined workflow and checklist for this procedure?

  Yes

  No

  N/A

• Was the workflow and checklist used during the procedure?

  Yes

  No

  N/A

• Where there deviations from the workflow and checklist during this procedure?

  Yes

  No

  N/A

• Were there any MR related scan issues?

  Yes

  No

  N/A

• Were there any Software issues?

  Yes

  No

  N/A

• Were there any product complaints during the procedure?

  Yes

  No

  N/A

• What info is there to pass along for the next case?

  Yes

  No

  N/A

• Action items to address?

  Yes

  No

  N/A

• Was there any discussion on potential next case or new use of product?

  Yes

  No

  N/A

Time (military)

• Patient arrived to the MRI suite

  Date

• Anesthesia, Patient Asleep, Foley, etc.

  Date

• Patient pinned

  Date

• Marking grid/Incision

  Date

• SmartFrame build complete

  Date

• Trajectory planning complete

  Date

• Alignment complete

  Date

• Insertion complete

  Date

• Therapy complete (if applicable)

  Date

• Out of Room

  Date

Total Time

• Patient IN to OUT of room

  Date

• Patient pinned to insertion

  Date

• Initial Scanning and entry point planning

  Date

• Surgical Time from Incision to complete build

  Date

• Scanning and Target replanning

  Date

• Time for Alignment

  Date

• Anesthesia Time

  Date

• Time for Therapy

  Date

• Closing and out of room

  Date

Left Side

• Projected Error

• Trajectory View

  Select X Value Y Value 2D radial error

  • X Value
  • Y Value
  • 2D radial error

• Actual Error

• Trajectory View

  Select X Value Y Value 2D radial error

  • X Value
  • Y Value
  • 2D radial error

• Was bias compensation used?

  Yes

  No

  N/A

• Did bias compensation work?

  Yes

  No

  N/A

• What was the final 2D radial error after compensation?

  Yes

  No

  N/A

• How did you rule out other factors in order to use bias compensation?

  Yes

  No

  N/A

Right Side

• Projected Error

• Trajectory View

  Select X Value Y Value 2D radial error

  • X Value
  • Y Value
  • 2D radial error

• Actual Error

• Trajectory View

  Select X Value Y Value 2D radial error

  • X Value
  • Y Value
  • 2D radial error

• Was bias compensation used?

  Yes

  No

  N/A

• Did bias compensation work?

  Yes

  No

  N/A

• How did you rule out other factors in order to use bias compensation?

  Yes

  No

  N/A

• What was the final 2D radial error after compensation?

  Yes

  No

  N/A

• How did you rule out other factors in order to use bias compensation?

  Yes

  No

  N/A