1. Medtronic Revo MRI™ SureScan® Pacing System
Training for Cardiology
Welcome to the Revo MRI SureScan Pacing System Training for Cardiology
UC# - UC EN
The Revo MRI™ SureScan® pacing system is MR Conditional designed to allow patients to undergo MRI under the specified Conditions for Use. A complete system, consisting of a Medtronic Revo MRI SureScan IPG implanted with two CapSureFix MRI™ SureScan® 5086MRI leads is required for use in the MRI environment.

2. Objectives Describe the importance of MRI
Identify the hazards and risks for patients and their implanted pacing systems in the MRI environment
Describe the components of the Revo MRI™ SureScan® pacing system
Explain SureScan® Technology and its importance
Explain the Clinical Implementation of the Revo MRI™ SureScan® pacing system
List the learning outcomes:
As a result of participating in this training session, you will be able to:
-Describe the importance of MRI
-Identify the hazards and risks for patients and their implanted pacing systems in the MRI environment
-Describe the Revo MRI SureScan™ pacing system consisting of the Revo MRI SureScan™ IPG, two CapSureFix MRI™ SureScan 5086MRI leads.
Define the differences between the CapSureFix MRI™ SureScan 5086MRI and the 5076 lead
-Explain SureScan™ technology and its importance
-Explain the clinical implementation on how to program the SureScan feature and identify a complete Revo MRI SureScan™ pacing system

3. MRI Basics What are some of the basics of MRI?
What are the hazards and risks for patients and their implanted Revo MRI™ SureScan® pacing system in the MRI environment
State that you will first focus on the basics and importance of MRI.

4. MR Conditional Labeling
ASTM Standard F2503 Defines Three Terms related to MRI:
MR Safe
MR Unsafe
State that the ASTM, also known as the ASTM-International, (American Society of Test and Measurement) is the standard that governs medical devices in the MRI environment. ASTM uses three terms to indicate safety of medical devices in the MRI environment.
Ask: “Which label is assigned to the Revo MRI SureScan pacing system?”
Answer: MR Conditional
MR Conditional

5. MRI Basics - Users Other GP/FP 9% 16% Cardiologists 15% Neurologists
24%
Ask: Which physicians are most likely to prescribe MRIs today?”
Image source: RSNA research, radiologists. December 2008.
16%
Oncologists
Orthopedic
* RSNA research, radiologists. December 2008. 5 5

6. Differential Diagnostic PowerCT
MRI
Point out the two different images.
Ask:
- “What differences do you see between the CT image versus the MRI scan?”
- “Where is the tumor?”
- “How might the differences you see in these two images be important?”
Image source courtesy of Torsten Sommer, Director, Department of Radiology, German Red Cross Hospital Bonn, Academic Institution of the University of Bonn, Marktstr, Neuwied, Germany
Image source: courtesy of Torsten Sommer, Director, Department of Radiology, German Red Cross Hospital Bonn, Academic Institution of the University of Bonn, Marktstr, Neuwied, Germany 6 6

7. Significant Unmet Clinical NeedCT
MRI
Delayed diagnosis
Missed diagnosis
Increased risk from
alternative imaging
modalities
Point out the visual benefit of this imaging tool by stating the following:
“Here are two images of a patient with an ischemic brain injury. On the left, is computed tomography, while the one on the right is an MRI. It’s easy to see the diagnostic difference between the two and to conclude that precluding patients from access to this type of diagnostic tool presents a great risk.”
Conclude by stating that the Revo MRI SureScan Pacing System is the result of rigorous and comprehensive testing and provides a solution for patients and physicians.
Note The most sensitive non-invasive test available today for intracranial hemorrhage is MRI. Knowing whether or not a stroke is hemorrhagic is critical before initiating thrombolytic therapy, as it may make THE difference between potential cure versus massive intracranial hemorrhage and death.
An untreated compressed spinal cord following trauma can result in permanent paralysis within just a few hours. The only reliable non-invasive way to precisely and reliably diagnose spinal cord compression is with MRI.
Finally, stroke is one of the most common causes of death in the US in general and in this population in particular. A non-invasive 30 second diffusion weighted MR imaging study of the brain may be the single most reliable way mankind has today to specifically and sensitively diagnose ischemic brain injury. In a few dozen seconds, perfusion weighted MRI can reliably highlight ischemic brain tissue at risk for stroke extension. As with the ischemic heart, "time is brain", and we can ill afford a delay in initiating appropriate therapeutic intervention - or initiating the wrong therapy. These extremely sensitive diagnostic tools are simply not available to pacemaker patients today.
Image source: Brain images courtesy knol.com.
Image source: Brain images courtesy knol.com. 7 7

8. CT versus MR – What Is the Difference?
Unique soft tissue differentiation abilities
Uses magnetic energy and RF
Contrast (if used) has low risk
Can be confining, noisy, scary
High capital costs CT
Better for bony tissue
Uses ionizing radiation (multiple CT means added risk to patient as x-ray dose is cumulative)
Contrast (if used) iodine-based, thus allergy reactions
Equipment costs less
Ask: “How do MR and CT differ?”
Point out the differences by contrasting the two systems bullet point by bullet point.
Slide References
ACR Appropriateness Criteria

9. Knowledge Check 3. What does MR Conditional mean? ANSWER
The item has regulatory approval for use in MR when certain specific Conditions for Use are met.
Ask: “What does MR Conditional mean?”
Listen for the following answer:
The item has regulatory approval for use in MR when certain specific conditions are met.

10. Hazards and Risks to the Patient and Pacing System
State that you want to discuss the hazards and risks to a patient and pacing system not designed for use in the MRI environment. Also the changes that have been made to ensure safety.

11. Hazards and Risks to Pacing Systems & Patients
State each of these fields, alone or in combination, may interact with the pacemaker and/or pacing lead, resulting in potential hazards and risks to the pacing system and the patient.
- Gradient and RF field can create energy along the lead causing cardiac arrhythmia
- Gradient fields can cause sensed energy that inhibits pacing
- RF energy can cause lead tip heating, resulting in tissue damage and loss of capture
Play video with audio
Slide reference
Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4):
Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4):

12. Summary of Hazards and Risks
Since 2008, the safety and risk concerns of MRIs in cardiac device patients have been documented in 17 studies.1-17
MRI can put pacemaker patients at risk for any of the following16:
Explain that MRI uses strong magnetic fields (Static, RF, and Gradient) to create images. Each of these fields contribute to specific safety concerns for pacemaker patients. So by putting an active implanted device, with complex electronic circuitry, and a lead which effectively functions as an antenna, into an environment with three powerful electromagnetic fields clearly creates the potential for interaction.
State we evaluated and tested each hazard category. Enhancements were made to both the pacemaker and lead with the goal of designing for inherent safety by mitigating the risks due to MRI related hazards. Preclinical testing demonstrated that each of these hazards- case heating, force, torque, vibration, and device interaction were adequately addressed. We also tested lead heating and unintended cardiac stimulation to the extremes of the MRI environment – and testing demonstrated that the Revo MRI SureScan pacing system poses low overall risk.
Slide references
1 Naehle CP, et al. Pacing Clin Electrophysiol. 2009;32:
2 Goldsher D, et al. Pacing Clin Electrophysiol. 2009;32:
3 Gimbel JR. Europace. 2009;11:
4 Naehle CP, et al. J Am Coll Cardiol. 2009;54:
5 Roguin A. J Am Coll Cardiol. 2009;54:
6 Mollerus M, et al. Pacing Clin Electrophysiol. 2008;31:
7 Pulver AF, et al. Pacing Clin Electrophysiol. 2009;32:
8 Nordbeck P, et al. Magn Reson Med. 2009;61:
9 Sutton R, et al. Trials. 2008;9:68.
10 Naehle CP, et al. Radiology. 2008;249:
11 Calcagnini G, et al. J Magn Reson Imaging. 2008;28:
12 Dyrda K, Khairy P. Expert Rev Cardiovasc Ther. 2008;6:
13 Gimbel JR. Pacing Clin Electrophysiol. 2008;31:
14 Nordbeck P, Bauer WR. Dtsch Med Wochenschr. 2008;133: [Article in German.]
15 Tandri H, et al. Heart Rhythm. 2008;5:
16 Roguin A, et al. Circulation. 2004;110:
17 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval.
1 Naehle CP, et al. Pacing Clin Electrophysiol. 2009;32:
2 Goldsher D, et al. Pacing Clin Electrophysiol. 2009;32:
3 Gimbel JR. Europace. 2009;11:
4 Naehle CP, et al. J Am Coll Cardiol. 2009;54:
5 Roguin A. J Am Coll Cardiol. 2009;54:
6 Mollerus M, et al. Pacing Clin Electrophysiol. 2008;31:
7 Pulver AF, et al. Pacing Clin Electrophysiol. 2009;32:
8 Nordbeck P, et al. Magn Reson Med. 2009;61:
9 Sutton R, et al. Trials. 2008;9:68.
10 Naehle CP, et al. Radiology. 2008;249:
11 Calcagnini G, et al. J Magn Reson Imaging. 2008;28:
12 Dyrda K, Khairy P. Expert Rev Cardiovasc Ther. 2008;6:
13 Gimbel JR. Pacing Clin Electrophysiol. 2008;31:
14 Nordbeck P, Bauer WR. Dtsch Med Wochenschr. 2008;133: [Article in German.]
15 Tandri H, et al. Heart Rhythm. 2008;5:
16 Roguin A, et al. Circulation. 2004;110:
17 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval.

13. Knowledge Check
1. Identify two of the hazards and risks to a pacing system and patients in an MRI environment?
ANSWER
Any of the following:
Case heating, force and torque, vibration, device interactions, lead heating, and unintended cardiac stimulation
Explain that you want to do three quick knowledge checks of the topics covered so far.
Ask: “What are two hazards and risks to a pacing systems and patients in an MRI environment?”
Listen for the following answers:
Possible answers: Case heating, force and torque, vibration, device interactions, lead heating and unintended cardiac stimulation 13 13

14. What is SureScan? MRI Conditions for Use
SureScan® Technology
What is SureScan?
MRI Conditions for Use
State that you will now discuss the importance of SureScan Technology and its components.

15. SureScan Technology SureScan technology is designed to:
Provide appropriate pacing therapy in MRI environment
Verify integrity of pacing system prior to an MRI scan to ensure patient safety
Mitigate risk due to hazardous effects of MRI-induced interference
Provide ease of use
Provide a communication aid for clinicians
Programmable: On and Off
Explain that the programmable SureScan feature allows pacemaker patients to undergo MRI scans while being safely supported with appropriate pacing therapy.
State We need to stress this is not just asynchronous pacing and that it has a number of redundant safety mechanisms that assure patient safety and system performance in the MRI: lead impedance, battery, reversion to SureScan vs. VVI.
Point out that it is designed to:
- Provide appropriate pacing therapy in MRI environment
- Verify integrity of pacing system prior to an MRI scan to ensure patient safety
- Mitigate risk due to hazardous effects of MRI-induced interference
- Provide ease of use
- Provide a communication aid for clinicians
Add that the SureScan feature must be programmed On prior to an MRI scan and Off following an MRI scan, and that programming steps are demonstrated later in this training.

16. What is SureScan? SureScan Technology
Brand given to Revo MRI IPG and the CapSureFix MRI SureScan 5086MRI leads
Corresponding software feature viewable via the 2090 programmer
Specific MRI Conditions for Use
Explain that SureScan technology is the brand given to Revo MRI Pacemaker and the CapSureFix MRI™ SureScan™ 5086MRI leads.
Describe how SureScan technology is represented in Revo MRI:
- Specific changes made to the device and lead design
- Corresponding programmable software viewable via 2090
- Specific Conditions for Use

17. Revo MRI SureScan Pacing System Important Risk Information
A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSureFix MRI SureScan 5086MRI leads is required for use in the MRI environment.
Any other pacing system combination may result in a hazard to the patient during an MRI scan.
When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing.
Refer to the Revo MRI SureScan Pacing System Conditions for Use located in the device manuals prior to scanning a patient. Consult Medtronic’s website at or call Medtronic at 1 (800)
State While these design changes provide the pacemaker patient access to MRI, the following important Risk Information applies.
Review important risk information for the Revo MRI SureScan pacing system.
Explain that there are certain system requirements associated with using the Revo MRI SureScan Pacing System.
- A complete SureScan pacing system is required for use in the MRI environment including:
a Revo MRI SureScan IPG (pacemaker) and
Two CapSureFix MRI SureScan 5068MRI leads
- Any other combination may result in a hazard to the patient during an MRI scan.
- The SureScan feature must be programmed to “On” prior to scanning a patient according to the specified conditions of use.
Add that the criteria are listed in the product manual, as well as on the programmer screen.

18. MRI Conditions for Use: Cardiology Requirements
Patients and their implanted systems must be screened to meet the following requirements:
no previously implanted (active or abandoned) medical devices, leads,
lead extenders or lead adaptors
no broken leads or leads with intermittent electrical contact as confirmed
by lead impedance history
a SureScan pacing system that has been implanted for a minimum of
6 weeks in the left or right pectoral region
pacing capture thresholds of ≤ 2.0 volts (V) at a pulse width of 0.4 ms
a lead impedance value of ≥ 200 ohms (Ω) and ≤ 1500 Ω
no diaphragmatic stimulation at a pacing output of 5.0 V at 1.0 ms
in patients whose device will be programmed to an asynchronous pacing
mode when MRI SureScan is on
Explain that patients and their implanted systems must be screened to meet the requirements as listed on the slide. 18 18

19. MRI Conditions for Use: Radiology Requirements
Horizontal cylindrical bore magnet, clinical MRI systems with a static
magnetic field of 1.5 Tesla (T) must be used.
Gradient systems with maximum gradient slew rate performance per
axis of ≤ 200 Tesla per meter per second (T/m/s) must be used.
The scanner must be operated in Normal Operating Mode:
- The whole body averaged SAR must be ≤ 2.0 watts per kilogram (W/kg).
- The head SAR must be < 3.2 W/kg.
The patient must be positioned within the bore such that the isocenter
(center of the MRI bore) is superior to the C1 vertebra or inferior to the
T12 vertebra.
The proper patient monitoring must be provided during the MRI scan.
The methods include visual and verbal contact with the patient,
electrocardiography, and pulse oximetry (plethysmography).
Specify the following additional radiology requirements:
- Horizontal cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be used
- MRI systems with a gradient slew rate performance per axis of ≤ 200 Tesla per meter per second (T/m/s) must be used
- The scanner must be operated in Normal Operating Mode:
The whole body averaged specific absorption rate (SAR) must be ≤ 2.0 watts per kilogram (W/kg).
The head SAR must be < 3.2 W/kg.
- The patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to the C1 vertebra or inferior to the T12 vertebra
- Proper patient monitoring must be provided during the MRI scan. The methods include visual and verbal contact with the patient, electrocardiography, and pulse oximetry (plethysmography) 19 19 19

20. MRI Conditions for Use: Positioning Criteria
Superior to C1 or
Patient must be positioned within bore such that the isocenter (center of MRI bore) is:
Inferior to T12
There are no restrictions on the anatomy that can be scanned, provided all criteria are met.
State The landmark, or the center of, view such that the isocenter (or center of MRI bore) is superior to C1 or inferior to T12. The anatomy within that region can still be imaged as long as the isocenter is superior to C1 or inferior to T12. 20 20

21. MRI Conditions for Use: Training Requirements
A health professional who has completed cardiology SureScan training must be present during the programming of the SureScan feature.
A health professional who has completed radiology SureScan training must be present during the MRI scan.
State the final Conditions for Use is the SureScan training requirement for Radiology and Cardiology health professionals. 21 21

22. The Stages of the Patient Care Pathway Process1 2 3 4 5
Revo MRI Implant
Referred for MRI
MRI Scheduling and Pre-Screening
Patient Presents for MRI
MRI Scan Received
Sure Scan Mode On
Sure Scan Mode Off
State that this outlines the steps needed for the patient to undergo a MRI procedure
Discuss when the patient is referred for an MR procedure there is a pre-screen and schedule process that needs to be conducted before check-in and the MR scan.
Ask participants to walk through the patient care pathway and review the Conditions for Use as needed.
Walk through the process while highlighting the following:
As you can see the Patient Care Pathway is broken into five categories:
1-First, the patient has a Revo MRI SureScan pacing system implanted
2-Then patient is referred for the MR procedure. The referring physician will follow their current process and contact the radiology department. Radiology will have to determine if, based on the area of anatomical interest and the diagnostic being requested, the conditions for use can be applied. They will likely gather this information from Medtronic’s website. If the conditions for use can be met they will then contact this patient’s cardiologist. The scan will need to be coordinated such that the patient can either visit the cardiology clinic for programming beforehand or the cardiology health professional is available at the scanning center.
3-At that time, the cardiology conditions for use will be satisfied.
4-The patient then proceeds to the radiologist for their MRI procedure. Once the patient presents for their MRI exam, they will again identify the presence of their implanted pacing system via the screening form. This will trigger the Technologist to confirm the appropriate Conditions for Use. At this time the SureScan feature can be programmed to ON, prior to scanning the patient.
5-After the patient has completed the MRI scan, the patient can be programmed back to the pre-scan settings along with checking the pacing capture threshold to ensure that there is a proper safety margin.

23. Knowledge Check
True or False: Pacing capture thresholds must be checked before and after an MRI scan?
ANSWER
True.
Explain that you want to do four quick knowledge checks.
Ask: True or False. Pacing capture thresholds must be checked before and after an MRI scan
Answer: True. 23 23

24. Knowledge Check
2. True or False: You CANNOT utilize MRI to scan the lungs for a tumor with Revo MRI SureScan pacing system?
ANSWER
False. The criteria state that the patient should be positioned within the MR such that the iso-center of the transmit coils are landmarked above C1 or below T12. This should not restrict the anatomy that can be scanned, including any anatomy within the chest cavity.
Ask: True or False: You CANNOT utilize MRI to scan the lungs for a tumor with Revo MRI?
Answer: False. The criteria state that the patient should be positioned within the MR such that the iso-center of the transmit coils are landmarked above C1 or below T12. This should not restrict the anatomy that can be scanned, including any anatomy within the chest cavity. Some (including of course our competitors) have "misinterpreted" this criteria as preventing chest scans and this is incorrect.

25. Clinical Implementation
Identifying a complete system
Programming the SureScan feature
State that you will now discuss the importance of positive system identification.
Ask “How can I be sure that the Revo MRI system is indeed what is implanted within this patient that I’m going to scan?”
State that Medtronic has developed a variety of tools that are available to make positive system identification. They include the radiopaque symbols on device and leads visible on an x-ray, the patient programmer printout, and the Patient ID card.
Add Let's take a closer look at each of these.

26. Identifying a complete system
State that Medtronic has developed a variety of tools that are available to make positive system identification.
Radiopaque MRI symbols visible on an x-ray
Patient programmer printout
Patient ID card

27. System Identification
Radiopaque MRI symbols can be used to identify a complete Revo MRI SureScan pacing system. The device MRI symbol is a wavy line, as shown here. A similar wavy line is visible on the lead, adjacent to the IPG.
Remind participants that the Radiopaque MRI symbols help identify the make and model.
Point out the wavy line included as part of the device’s radiopaque symbol. A similar wavy line is visible on the lead, adjacent to the IPG.

28. System Identification
The programmer printout contains device and lead information, which can be used to identify a complete Revo MRI SureScan pacing system.
The programmer printout can be used to identify the complete Revo MRI SureScan pacing system, the reference to MRI is present in the device information for the IPG and two leads, indicating the complete system is MR Conditional and thus safe to scan according to Conditions for Use.
Explain that another method for determining whether the patient is eligible for an MRI Scan is to study the information on the patient programmer printout.
Point out that for the Revo MRI pacing system, each component of the system contains “MRI” as part of the model name, indicating the system is MR Conditional, and thus safe to scan according to the conditions of use.
Note: For example the cardiology community will program the MRI SureScan Settings most appropriate for each patient. The radiology community can use this programmer print out as a tool for positive system identification for a complete MRI SureScan pacing system as the Device Information portion at the bottom of the print out contains the implanted device and lead information. For the Revo MRI SureScan pacing system, each component of the system contains “MRI” as part of the model name, indicating the system is MR Conditional, and thus safe to scan according to the conditions for use.

29. System Identification
In addition to radiopaque MRI symbols and the programmer printout, the Patient ID Card can be used to identify a complete Revo MRI SureScan pacing system.
Explain that the Patient ID card can also provide necessary system information.
Direct participants to the Patient ID card on the slide.
Point out that this patient has a complete Revo MRI SureScan pacing system.
Add that this can be verified in two ways, by looking at the statement on the front of the card, “This patient has a complete MR conditional pacing system…” and at the model #s on the back of the card as seen in this example
Ask: participants what the model numbers for the components of the MRI system are:
Answer:
- Revo MRI IPG - RVDR01
- Lead MRI
Notice this patient has a complete Revo MRI SureScan pacing system. You can verify this in two ways on the card: the model numbers on the front of the card, and the statement, “This patient has a complete MR conditional pacing system" on the back of the card.
The back of the patient ID card states: “This patient has a complete MR Conditional pacing system implanted, consisting of a SureScan pacemaker and two SureScan leads.”

30. System Identification Patient ID Card – Incomplete System
Point out that this patient ID card indicates that the patient has incomplete MR conditional system.
Ask: “Are these patients eligible for an MRI Scan?”
Answer: No, the patients must have an MR conditional pacemaker and 2 CapSureFix MRI SureScan 5086MRI leads.
The back of the patient ID card does not state: “This patient has a complete MR Conditional pacing system implanted, consisting of a SureScan pacemaker and two SureScan leads.” included on these cards.

31. Knowledge Check
3. List the three tools used to identify a complete SureScan System.
ANSWER
Medtronic has developed a variety of tools that are available to make positive system identification.
1) Radiopaque MRI symbols visible on an x-ray
2) Patient programmer printout
3) Patient ID card
Ask: List the three tools used to identify a SureScan System.
Answer: Medtronic has developed a variety of tools that are available to make positive system identification.
- Radiopaque MRI symbols visible on an x-ray
- Patient programmer printout
- Patient ID card

32. Programming of SureScan
Demonstration
State that you will now lead the class through a programming demonstration of SureScan.

33. Programming Steps 33 Walk participants through the steps:
Revo MRI RVDR01
Walk participants through the steps:
- After turning on the programmer, place the programming head over the device. The programmer will automatically recognize, load the software and interrogate the device.
- Touch the small pacemaker icon on the right hand side to access the Parameters screen (shown above).
- Touch Additional Features to continue. 33

34. Access SureScan 34 Walk participants through the steps:
Revo MRI RVDR01
Walk participants through the steps:
- Touch the MRI SureScan programming field and you will automatically be advanced to the next screen.
Point out that if the device has reached RRT (elective or recommended replacement due to low battery voltage) SureScan programming is also not allowed. 34

35. The SureScan Checklist
Revo MRI RVDR01
Revo MRI RVDR01
Walk participants through the steps:
- Confirm that the MRI SureScan checklist criteria are met by clicking on it with the stylus.
- Touch OK to advance to the next programming screen 35

36. Program the Pacing Mode
Revo MRI RVDR01
Walk participants through the steps:
- The MRI SureScan programming screen automatically appears and MRI SureScan is ON but NOT programmed.
- To continue you must select the MRI SureScan Pacing mode.
- Touch the Mode programming field to continue, and to advance the slide. 36

37. Program the Pacing Mode
Revo MRI RVDR01
Walk participants through the steps:
-The MRI mode choices automatically appear.
-You must select DOO, VOO or AOO (asynchronous modes) or ODO ( a mode that provides sensing but NO pacing, essentially the pacemaker is OFF). Some information to help make the appropriate mode:
Pacing percentage counters
Rate histograms and
Patient’s indication for pacing
Perform an Underlying Rhythm Test
Ask: “Which mode should you consider if the patient has adequate underlying rhythm and no evidence of heart block?”
Answer: “For patients with an adequate underlying rhythm and no evidence of heart block, consider ODO. For others consider asynchronous pacing for the duration of the scan.”
- Touch the DOO field to be automatically directed to the next programming screen (and to advance the slide)
Note: Pacing mode and rate (if applicable) are to be programmed per the physician’s discretion. Based on whether the patient needs pacing support or not, an asynchronous pacing mode (DOO, AOO, or VOO) or sensing only mode (ODO) can be programmed. Sensed events will be ignored by the device when MRI SureScan is programmed to On, regardless of the programmed mode. 37

38. Program a Pacing Rate 38 Walk participants through the steps:
Revo MRI RVDR01
Walk participants through the steps:
- Choosing a Mode will automatically advance you to the next screen.
Note that your mode choice (DOO) populates the Mode field. Since we have selected an asynchronous mode we must also choose a pacing rate. Had we selected ODO, the Rate and other fields would not appear.
Ask: “What other fields populate when you select an asynchronous mode?”
Answer: “The AV delay fields, and Pacing Output fields are automatically populated. These are non-programmable parameters during SureScan operation.”
- Touch the MRI Lower Rate programming field to access your rate choices (and to advance the slide). 38

39. Program a Pacing Rate 39 Walk participants through the steps:
Revo MRI RVDR01
Walk participants through the steps:
The rate choices are from 30 PPM to 120 PPM in 5 PPM increments. Consider choosing a rate that overdrives the patients intrinsic rate , if one exists.
Let’s assume we’ve been asked to program a rate of 80PPM. Touch 80 on the screen to populate the rate field and advance the slide. 39

40. Confirm the Pacing Rate
Revo MRI RVDR01
Discuss: that SureScan is now operational.
Note the Mode in the upper left corner, the Therapy/Detection and MRI messages, and the change in the rhythm.
Note also that programming SureScan has automatically changed the pacing outputs to 5V and 1.0 ms. If the pacemaker had been programmed to values greater than 5.0V or 1.0 ms, the higher of these values would have been used for SureScan programming.
- For documentation of the Programming Touch Print (and to advance the slide) 40

41. Confirm SureScan Programming and Print
State that SureScan is now operational. Note the Mode in the upper left corner, the Therapy/Detection, the MRI messages, and the change in the rhythm. Note also that programming SureScan has automatically changed the pacing outputs to 5V and 1.0 ms. If the pacemaker had been programmed to values greater than 5.0V or 1.0 ms, the higher of these values would have been used for SureScan programming.
Note for documentation of the Programming, touch Print (and to advance the screen). 41

42. Example of Programmer Printout
Point out that this is an example of the documentation. 42

43. Return to the Original Parameters
Walk participants through the steps:
Upon completion of the scan, and once the patient reaches a safe area for you to work, use the following to disable SureScan.
- Interrogate the device as before. You will be automatically directed to the MRI SureScan programming screen. In order to program any parameter you must first disable MRI SureScan. Device check and programming parameters to be verified for applicability for each patient.
- To disable, simply touch the MRI SureScan programming field to change the parameter from “On” to “Off”.
- Touch Program to complete the steps (and advance the slide)
Note Programming MRI-SureScan Off automatically restores all:
Pre-scan programmed parameters, these are noted on the programming screen
Diagnostics
Detections originally programmed.
- Once SureScan is programmed off, perform atrial and ventricular pacing threshold tests to confirm the programmed outputs are at least at a 2X safety margin.
- Reprogram if necessary. 43

44. This concludes the demonstration
Return to the Original Parameters
Revo MRI RVDR01
This concludes the demonstration
Walk participants through the steps:
MRI SureScan is now “Off” and originally programmed parameters have been restored.
Note In order to make any changes to these simply touch Close and then OK and the Parameters Icon and proceed normally. A notation has been entered in the Observations window on the Quick Look screen: “ MRI SureScan On (date) MRI SureScan Off (date) Data was not collected during MRI SureScan.”
Device check and programming parameters to be verified for applicability for each patient.
- If you wish to provide documentation of this final programming step – Touch Print. (touch print to advance the slide). 44

45. Brief Statement
The Revo MRI™ SureScan® pacing system is MR Conditional and as such is designed to allow patients to undergo MRI under the specified Conditions for Use.
Indications
The Revo MRI™ SureScan® Model RVDR01 IPG is indicated for use as a system consisting of Medtronic Revo MRI SureScan IPG implanted with two CapSureFix MRI™ SureScan® 5086MRI leads. A complete system is required for use in the MRI environment.
The Revo MRI SureScan Model RVDR01 IPG is indicated for the following:
Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity
Accepted patient conditions warranting chronic cardiac pacing include:
- Symptomatic paroxysmal or permanent second- or third-degree AV block
- Symptomatic bilateral bundle branch block
- Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders
- Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias
State that the Brief Statement clearly defines the device indications, contraindications, warnings, and precautions.
Ask participants to review the brief statement.

46. patients with one or more of the above pacing indications.
The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include:
Various degrees of AV block to maintain the atrial contribution to cardiac output
VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm
Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia
patients with one or more of the above pacing indications.
Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications.
The device has been designed for the MRI environment when used with the specified MR Conditions for Use.
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47. Contraindications
The device is contraindicated for:
Implantation with unipolar pacing leads
Concomitant implantation with another bradycardia device
Concomitant implantation with an implantable cardioverter defibrillator
There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate.
The patient’s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implantation procedure used by the physician.
Rate responsive modes may be contraindicated in those patients who cannot tolerate pacing rates
above the programmed Lower Rate
Dual chamber sequential pacing is contraindicated in patients with chronic or persistent
supraventricular tachycardias, including atrial fibrillation or flutter
Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance
ATP therapy is contraindicated in patients with an accessory antegrade pathway

48. Warnings and Precautions
Changes in patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia device electrical reset or device damage. Do not place transthoracic defibrillation paddles directly over the device. Use of the device should not change the application of established anticoagulation protocols.
Do not scan the following patients:
Patients who do not have a complete SureScan® pacing system, consisting of a SureScan device
and two CapSureFix MRITM SureScan® 5086MRI leads;
Patients who have previously implanted devices, or broken or intermittent leads;
Patients who have a lead impedance value of < 200 Ω or > 1500 Ω;
Patients with a SureScan pacing system implanted in sites other than the left and right
pectoral region;
Patients positioned such that the isocenter (center of MRI bore) is inferior to C1 vertebra and
superior to the T12 vertebra
See the device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI Conditions of Use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic at and/or consult Medtronic’s website at
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49.
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