You are on page 1of 6

Brief Statement

Medtronic SureScan pacing systems, including the Advisa DR MRI and There are no known contraindications for the use of pacing as a therapeutic
Revo MRI SureScan pacing systems, are MR-Conditional and as such are modality to control heart rate. The patients age and medical condition,
designed to allow patients to undergo MRI under the specified conditions however, may dictate the particular pacing system, mode of operation, and
for use. implant procedure used by the physician.
Indications R  ate-responsive modes may be contraindicated in those patients who
A complete SureScan pacing system is required for use in the MRI cannot tolerate pacing rates above the programmed Lower Rate
environment. D  ual chamber sequential pacing is contraindicated in patients with chronic
The Advisa DR MRI SureScan Model A2DR01 IPG is indicated for use as or persistent supraventricular tachycardias, including atrial fibrillation or
a SureScan pacing system consisting of an Advisa DR MRI SureScan IPG flutter
implanted with two CapSureFix MRI SureScan 5086MRI leads A  synchronous pacing is contraindicated in the presence (or likelihood) of
The Revo MRI SureScan Model RVDR01 IPG is indicated for use as a SureScan competition between paced and intrinsic rhythms
pacing system consisting of a Revo MRI SureScan IPG with two CapSureFix S ingle chamber atrial pacing is contraindicated in patients with an AV
MRI SureScan 5086MRI leads conduction disturbance
Medtronic SureScan pacing systems are indicated for the following: A  TP therapy is contraindicated in patients with an accessory antegrade
Rate adaptive pacing in patients who may benefit from increased pacing pathway
rates concurrent with increases in activity Warnings and Precautions
Accepted patient conditions warranting chronic cardiac pacing include: Changes in patients disease and/or medications may alter the efficacy of
Symptomatic paroxysmal or permanent second or third-degree AV block the devices programmed parameters. Patients should avoid sources of
Symptomatic bilateral bundle branch block magnetic and electromagnetic radiation to avoid possible underdetection,
S ymptomatic paroxysmal or transient sinus node dysfunctions with or inappropriate sensing and/or therapy delivery, tissue damage, induction
without associated AV conduction disorders of an arrhythmia, device electrical reset, or device damage. Do not place
Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia transthoracic defibrillation paddles directly over the device. Use of the
or some forms of symptomatic tachyarrhythmias device should not change the application of established anticoagulation
Vasovagal syndromes or hypersensitive carotid sinus syndromes protocols.
The systems are also indicated for dual chamber and atrial tracking modes in Patients and their implanted systems must be screened to meet the MRI
patients who may benefit from maintenance of AV synchrony. Dual chamber Conditions of Use. Do not scan patients who do not have a complete

UC201204244b EN Medtronic, Inc. 2013. Minneapolis, MN. All Rights Reserved. Printed in USA. 12/2013
modes are specifically indicated for treatment of conduction disorders that Medtronic SureScan pacing system consisting of a SureScan device (Advisa
require restoration of both rate and AV synchrony, which include: MRI or Revo MRI) and two CapSureFix SureScan leads; patients who have
Various degrees of AV block to maintain the atrial contribution to cardiac broken, abandoned or intermittent leads; or patients who have a lead
output impedance value of < 200 or > 1,500 .

SureScan MRI
V VI intolerance (for example, pacemaker syndrome) in the presence of Potential Complications
persistent sinus rhythm Potential complications include, but are not limited to, rejection
phenomena, erosion through the skin, muscle or nerve stimulation,
Antitachycardia pacing (ATP) is indicated for termination of atrial
oversensing, failure to detect and/or terminate arrhythmia episodes,
tachyarrhythmias in bradycardia patients with one or more of the above

Pacing Systems
acceleration of tachycardia, and surgical complications such as hematoma,
pacing indications.
infection, inflammation, and thrombosis. Potential lead complications
Contraindications include, but are not limited to, valve damage, fibrillation, thrombosis,
Medtronic SureScan pacing systems are contraindicated for: thrombotic and air embolism, cardiac perforation, heart wall rupture,
Concomitant implantation with another bradycardia device cardiac tamponade, pericardial rub, infection, myocardial irritability, and
Concomitant implantation with an implantable cardioverter defibrillator pneumothorax. Other potential complications related to the lead may
include lead dislodgement, lead conductor fracture, insulation failure,
threshold elevation, or exit block. The SureScan system has been designed
www.medtronic.com to minimize potential complications in the MRI environment. Potential pacemakers and MRI access
MRI complications include, but are not limited to, lead electrode heating
World Headquarters Medtronic USA, Inc.
and tissue damage resulting in loss of sensing or capture or both, or
induced currents on leads resulting in continuous capture, VT/VF, and/or
finally coming together
Medtronic, Inc. Toll-free: 1 (800) 328-2518 hemodynamic collapse.
710 Medtronic Parkway (24-hour technical support for See the device manuals before performing an MRI Scan for detailed information
Minneapolis, MN 55432-5604 physicians and medical regarding the implant procedure, indications, MRI conditions of use,
USA professionals) contraindications, warnings, precautions, and potential complications/adverse
Tel: (763) 514-4000 events. For further information, call Medtronic at 1 (800) 328-2518 and/or consult
Fax: (763) 514-4879 Medtronics website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the
order of a physician. Medtronic SureScan pacing systems Advisa MRI and Revo MRI are MR-Conditional and as such, are designed to
allow patients to be safely scanned by an MRI machine when used according to the specified MRI conditions for use. A
complete SureScan pacing system, including a Medtronic MRI SureScan IPG (Advisa MRI or Revo MRI) and two CapSureFix
MRI SureScan leads are required for use in the MRI environment.
Risks of Scanning
What Is a Pacemaker? Non-MRI Labeled Pacemakers

Pacemaker
When people refer to a pacemaker, they are actually Since 2008, the safety and risk concerns of MRIs in cardiac
discussing a pacing system, which includes the device patients have been documented in 17 studies.1-17
pacemaker, and leads. MRI can put pacemaker patients at risk for any of the following16:
A pacemaker is a small device that is implanted under the skin, typically
Lead Heating Induced Arrhythmias Device Interactions
just below the collarbone. The device delivers therapies to treat irregular Tissue damage may affect May lead to a single or Pacemaker malfunction or
interrupted, or slow heartbeats. pacing therapy. intermittent stimulation, failure may affect pacing
The conductive pacing or sustained tachycardia. therapy.
A pacemaker can be programmed in different pacing modes based on the
lead acts as an antenna, The gradient and The gradient, radiofrequency,
patients condition. For example, a patient with complete heart block would picking up radiofrequency radiofrequency fields will and static fields may adversely
be programmed in an asynchronous mode and paced at a fixed rate. energy. A portion of this induce voltages in pacemaker affect the electrical operation
energy is dissipated as heat leads that will be applied to of the pacemaker system if
in the cardiac tissue near the pacing lead electrodes. its operation is not protected
Leads are thin, soft, insulated wires the tip electrode. If these voltage pulses are from the effects of those
about the size of a spaghetti noodle. large enough, they may fields.
The leads carry the electrical directly stimulate the heart.
impulse from the pacemaker
to your heart and relay
information about the
hearts natural activity Lead heating can
back to your pacemaker. Dual chamber be associated with
pacemaker with change in energy
two leads needed to pace the
heart (Pacing Capture
Threshold) and may
cause tissue damage.
Specifically Engineered for
Meeting the Need of MRI MRI Safety
Pacemaker Implants in an Aging Population. SureScan Pacing System
The number of pacemakers currently implanted in the United States Device Design Solutions
is approximately 1.5 million18,19 SureScan Pacing Mode technology
Circuit design immune to interference
Minimize ferromagnetic content

Meeting the Need of MRI


Isolated circuit board
Average Age of Pacemaker Patient Digital (Hall Sensor) versus
mechanical sensor (Reed Switch)
13%
Age 2564
86% Lead Design
Age 65+ Lead inner conductor
Elderly patients are the coil design mitigates lead heating
primary users of MRI:
individuals over age 65
are twice as likely to
need an MRI compared
to younger recipients.20 CapSureFix SureScan
MRI Pacing Lead
The First Pacing Systems
Evidence of Safety FDA-Approved for MRI Use
5 years post-approval worldwide clinical experience* SureScan Pacing Systems are labeled
More than 2,700 patients studied MR-Conditional
without adverse impact on patient outcomes or pacemaker system functions 21-23 MR Under specific conditions of use, there are no known
hazards or risks
Device conditions
Thousands of MRI scans performed in the United States ** Cardiology conditions
Radiology conditions
Lead heating model analyzed over

2 million scanning scenarios


to evaluate risk of tissue damage in MRI environment SureScan pacing systems have completed clinical evaluation, regulatory
review, and FDA approval and are safe for use when used according to the MRI
conditions for use as defined in the SureScan manual
The implanted system must consist solely of a Medtronic Advisa MRI Model
A2DR01or Revo MRI Model RVDR01 SureScan device and two CapSureFix MRI
SureScan Model 5086MRI leads
Any other pacing system combination may result in a hazard to the patient

Evidence
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
Human Body Library Lead Paths
Refer to the SureScan Pacing System Conditions for Use located in
the device manuals prior to scanning a patient. Consult Medtronics website
* CE Mark received September 2008 and FDA-approval February 2011.
** As of November 2013. at www.medtronic.com/mri or call Medtronic at 1 (800) 328-2518.
Radiology Checklist and Conditions for Use Doe, John
123 Main St.
Any Town, MN 55555

Radiology Checklist
Implant Date Serial# Model#
01/02/2010 PTN600772A RVDR01
01/02/2010 LFP005555V 5086MRI52
01/02/2010 LFP005556V 5086MRI58
Please contact us with changes at 1 (800) 551-5544.

MRI Procedure Requirements Implanted Device Identification

Step 1: Screen Patient Doe, John


123 Main St.
Confirm that the patient does not have any lead extenders, lead adaptors, or abandoned
 erify that patient has a complete SureScan Pacing System (consisting of a Revo
V Any Town, MN 55555 leads.
Implant Date Serial# Model#
MRI or Advisa MRI SureScan IPG and two01/02/2010
CapSureFix MRI SureScan
PTN600772A A2DR01 leads) Step 2: Schedule
01/02/2010 LFP005555V 5086MRI52

1. Use the patient ID card to identify the device and leads implanted.
01/02/2010 LFP005556V
Please contact us with changes at 1 (800) 551-5544.
5086MRI58
Contact cardiology to obtain clearance documents, including:
Implanted Device Identification 1. SureScan Programming Order.
For Medical Questions, Contact Your Physician
Doe, John
Schedule a health professional who will monitor patient during MRI exam.
I have a Revo MRI SureScan pacemaker implanted.
123 Main St.
Any Town, MN 55555
This patient has a complete MR Conditional pacing system
implanted, consisting of a SureScan pacemaker and two
Schedule a trained professional who will program the patients pacemaker in and out of
Implant Date Serial# Model#
SureScan leads. For important MRI safety information, visit
www.medtronic.com/mri or call 1 (800) 551-5544.
SureScan mode.
01/02/2010 PTN600772A RVDR01 If medical questions or emergency, call:
01/02/2010
01/02/2010
LFP005555V
LFP005556V
5086MRI52
5086MRI58
First Name Last Name, MD
(000) 000-0000 My device may
Step 3: Prep Patient for Scan
First Name Last Name, MD trigger metal
Please contact us with changes at 1 (800) 551-5544. (000) 000-0000 detection systems.
Confirm a health professional, who has completed radiology SureScan training, is present
Implanted Device Identification
Ensure device is programmed in SureScan mode prior to the MRI examination.
UC200904855 EN Medtronic, Inc. 2010. www.medtronic.com 04/2010

For Medical Questions, Contact Your Physician Step 4: Conduct MRI Scan Using the Following Guidelines
Doe, John I have an Advisa MRI SureScan pacemaker implanted.
123 Main St. This patient has a complete MR Conditional pacing system Horizontal cylindrical bore magnet MRI system of 1.5 Tesla must be used in Normal
Any Town, MN 55555 implanted, consisting of a SureScan pacemaker and two
SureScan leads. For important MRI safety information, visit
www.medtronic.com/mri or call 1 (800) 551-5544.
Operating Mode.
Implant Date Serial# Model#
01/02/2010 PTN600772A A2DR01 If medical questions or emergency, call: Gradient systems with maximum gradient slew rate performance per axis of 200 Teslas
01/02/2010 LFP005555V 5086MRI52 First Name Last Name, MD
01/02/2010 LFP005556V 5086MRI58 (000) 000-0000
First Name Last Name, MD
My device may
trigger metal
per meter per second (T/m/s) must be used.
Please contact us with changes at 1 (800) 551-5544. (000) 000-0000 detection systems.
Whole body averaged SAR must be 2W/kg, head averaged SAR must be 3.2W/kg.
Implanted Device Identification
Proper patient monitoring must be provided during the MRI scan. This includes visual and
UC200904855 EN Medtronic, Inc. 2010. www.medtronic.com 04/2010
For Medical Questions, Contact Your Physician
I have a Revo MRI SureScan pacemaker implanted.
2. CallThisMedtronic at 1MR(877)
patient has a complete MRI-7677
Conditional pacing system to
verbal contact with the patient, and monitoring heart rate using instrumentation such as
implanted, consisting of a SureScan pacemaker and two
verify the
SureScan patients
leads. For important pacing system.
MRI safety information, visit pulse oximetry or electrocardiography. An external defibrillator must be available nearby
www.medtronic.com/mri or call 1 (800) 551-5544.
3. UseFirstthe
If medical patient records to verify a
questions or emergency, call: during the MRI procedure.
Name Last Name, MD
complete
(000) 000-0000Revo MRI or Advisa MRI
Step 5: Manage Patient Post-Scan
My device may
First Name Last Name, MD trigger metal

system has been implanted.


(000) 000-0000 detection systems.

UC200904855 EN Medtronic, Inc. 2010. www.medtronic.com 04/2010

4. Performing an x-ray can help identify Ensure a trained professional programs patients device back to previous settings.
radiopaque MRI symbols.
For Medical Questions, Contact Your Physician
I have an Advisa MRI SureScan pacemaker implanted.
This patient has a complete MR Conditional pacing system
implanted, consisting of a SureScan pacemaker and two
SureScan leads. For important MRI safety information, visit
www.medtronic.com/mri or call 1 (800) 551-5544.
If medical questions or emergency, call:
First Name Last Name, MD
Steps to become a References
1
N
 aehle CP, Zeijlemaker V, Thomas D, et al. Evaluation of cumulative effects of MR
imaging on pacemaker systems at 1.5 Tesla. Pacing Clin Electrophysiol. December
12
 yrda K, Khairy P. Implantable rhythm devices and electromagnetic interference:
D
myth or reality? Expert Rev Cardiovasc Ther. July 2008;6(6):823-832.

SureScan Center
2009;32(12):1526-1535. 13
Gimbel JR. Magnetic resonance imaging of implantable cardiac rhythm devices
2
Goldsher D, Jahshan S, Roguin A. Successful cervical MR scan in a patient at 3.0 tesla. Pacing Clin Electrophysiol. July 2008;31(7):795-801.
several hours after pacemaker implantation. Pacing Clin Electrophysiol. October 14
Nordbeck P, Bauer WR. [Safety of cardiac pacemakers and implantable
2009;32(10):1355-1356. cardioverter-defibrillators in magnetic resonance imaging. Assessment of the
3
Gimbel JR. Unexpected asystole during 3T magnetic resonance imaging aggregate function at 1.5 tesla.] Dtsch Med Wochenschr. March 2008;133(13):624-
of a pacemaker-dependent patient with a modern pacemaker. Europace. 628. [Article in German.]
September 2009;11(9):1241-1242. 15
Tandri H, Zviman MM, Wedan SR, Lloyd T, Berger RD, Halperin H. Determinants
4
Naehle CP, Strach K, Thomas D, et al. Magnetic resonance imaging at 1.5-T in of gradient field-induced current in a pacemaker lead system in a magnetic

Visit www.mrisurescan.com patients with implantable cardioverter-defibrillators. J Am Coll Cardiol. August 4,


2009;54(6):549-555. 16
resonance imaging environment. Heart Rhythm. March 2008;5(3):462-468.
Roguin A, Zviman MM, Meininger GR, et al. Modern pacemaker and implantable
Roguin A. Magnetic resonance imaging in patients with implantable cardioverter/defibrillator systems can be magnet resonance imaging safe: in
On the website you can:
5

cardioverter-defibrillators and pacemakers. J Am Coll Cardiol. August 4, vitro and in vivo assessment of safety and function at 1.5 T. Circulation. August 3,
2009;54(6):556-557. 2004;110(5):475-482.
6
Mollerus M, Albin G, Lipinski M, Lucca J. Cardiac biomarkers in patients with 17
Medtronic, Inc. Revo MRI SureScan pacing system clinical summary. http://
1. Complete the Radiology training permanent pacemakers and implantable cardioverter-defibrillators undergoing manuals/medtronic.com.
an MRI scan. Pacing Clin Electrophysiol. October 2008;31(10):1241-1245. 18
K alin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and
2. Create a SureScan patient workflow process for your MRI Center 7
Pulver AF, Puchalski MD, Bradley DJ, et al. Safety and imaging quality of MRI in
pediatric and adult congenital heart disease patients with pacemakers. Pacing
defibrillator patients. PACE. April 2005;28(4):326-328.
19
Z  han C, Baine WB, Sedrakyan A, Steiner C. Cardiac device implantation in the
Clin Electrophysiol. April 2009;32(4):450-456. United States from 1997 through 2004: a population-based analysis. Gen Intern
3. Register your MRI center so patients with a SureScan pacing system 8
Nordbeck P, Weiss I, Ehses P, et al. Measuring RF-induced currents inside Med. January 2008;23(suppl 1):13-19.
are able to locate your center when they need an MRI scan implants: impact of device configuration on MRI safety of cardiac pacemaker
leads. Magn Reson Med. March 2009;61(3):570-578.
20
G lobal Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment
A Global Strategic Business Report. San Jose, CA. 2002.
9
Sutton R, Kanal E, Wilkoff BL, et al. Safety of magnetic resonance imaging of 21
R amza, et al. Real-World Experience with Pacemakers Designed for Safe
patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical MRI Use: SureScan Post-Approval Study, presented at Heart Rhythm Society
study design. Trials. December 2, 2008;9(1):68. Conference, May 2013.
10
Naehle CP, Meyer C, Thomas D, et al. Safety of brain 3-T MR imaging with 22
Wilkoff BL, Bello D, Taborsky M, et al. Magnetic resonance imaging in patients
transmit-receive head coil in patients with cardiac pacemakers: pilot prospective with a pacemaker system designed for the magnetic resonance environment.
study with 51 examinations. Radiology. December 2008;249(3):991-1001. Heart Rhythm. January 2011;8(1):65-73.
11
Calcagnini G, Triventi M, Censi F, et al. In vitro investigation of pacemaker lead 23
G imbel JR, Bello D, Schmitt M, et al. Randomized trial of pacemaker and lead
heating induced by magnetic resonance imaging: role of implant geometry. system for safe scanning at 1.5 Tesla. Heart Rhythm. May 2013;10(5):685-691.
J Magn Reson Imaging. October 2008;28(4):879-886.

You might also like