Download MRI SureScan®Pacing Systems

MRI SureScan® Pacing Systems
Cardiology Checklist
MRI Procedure Requirements
1.Patient pre-screening requirements
complete SureScan® pacing system, which consists of an approved combination MRI SureScan device with
A
SureScan lead(s), is required for use in the MRI environment.
System has been implanted for more than 6 weeks
Pulse generator was implanted in the pectoral region
No lead extenders, lead adaptors, or abandoned leads
Leads are electrically intact (impedance between 200 and 1,500 ohms)
No broken or abandoned leads or leads with intermittent electrical contact as confirmed by lead impedance history
o diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be
N
programmed to an asynchronous pacing mode when MRI SureScan is On
2.Pre-scan pacemaker programming requirements
health professional who has completed cardiology SureScan training must be present during the programming
A
of the SureScan feature
Provide order for pacing support needed and the appropriate pacing rate during SureScan operation
– For patients who require pacing support, the MRI pacing mode must be set to DOO, AOO, VOO, or OVO while the MRI
SureScan feature is programmed On
– For patients who do not require pacing support, the MRI pacing mode should be set to ODO or OVO while the MRI
SureScan feature is programmed On
Perform threshold check to confirm that atrial and ventricular thresholds do not exceed 2.00 V at 0.4 ms
Confirm SureScan is programmed On prior to scan (see sample device programming on the back)
Print SureScan programming report for documentation to accompany patient to the MRI procedure
3.Post-scan pacemaker programming requirements
rogram SureScan Off after the MRI procedure; device returned to previous settings
P
(see programming steps on the back)
Check the pacing thresholds to ensure that there is a proper safety margin
For complete MRI Conditions for Use, operating and programming guidelines and restrictions, refer to the
SureScan Pacing System Reference Manual, call 1 (800) 505-4636, or visit www.medtronic.com/MRI.
SureScan Programming Steps
Prior to the MRI procedure
1. After accessing the Parameters screen, select [Additional
Features].
2. Select MRI SureScan programming field to On.
3. From here, you will need to:
• Program a mode (DOO, VOO, AOO, ODO, or OVO)
• Program a rate (for asynchronous modes only, 30-120)
Touch [PROGRAM] to complete the steps.
Touch [Print...] for documentation.
After the MRI procedure
1. Interrogate the device, and you will be automatically
brought to the SureScan programming screen.
2. Program SureScan Off. Pre-scan parameters are
automatically restored.
3. Check the pacing capture threshold to ensure that there is
a proper safety margin.
Doe, John
123 Main St.
Any Town, MN 55555
Implant Date
01/02/2010
01/02/2010
01/02/2010
Radiology Checklist
Advisa DR MRI® SureScan programming screen
Serial#
PTN600772A
LFP005555V
LFP005556V
Model#
A2DR01
50xxMRI52
50xxMRI58
Please contact us with changes at 1 (800) 551-5544.
Implanted Device Identification
Step 1: Screen Patient
Verify that patient has a complete SureScan Pacing System (consisting of an approved combination MRI SureScan device with
SureScan lead(s)) using one or more of the following methods:
• Use the patient ID card to identify the device and leads implanted
For Medical Questions, Contact Your Physician
Doe, John
123 Main St.
Any Town, MN 55555
Implant Date
01/02/2010
01/02/2010
01/02/2010
Serial#
PTN600772A
LFP005555V
LFP005556V
The 5076 MRI and 5086MRI
SureScan leads are the
only MR-Conditional leads
available from Medtronic.
Model#
A2DR01
50xxMRI52
50xxMRI58
Please contact us with changes at 1 (800) 551-5544.
Implanted Device Identification
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
(000) 000-0000
My device may
trigger metal
First Name Last Name, MD
detection systems.
(000) 000-0000
Revo MRI and Advisa MRI
SureScan pacemakers are the
only MR-Conditional pacemakers
available from Medtronic.
UC200904855 EN © Medtronic, Inc. 2010. www.medtronic.com 04/2010
• Use the patient records to verify a complete SureScan Pacing System has been implanted
• Perform an x-ray to identify radiopaque MRI symbols, if applicable. The SureScan devices contain a radiopaque marker.
The SureScan leads may or may not contain a radiopaque marker.
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
(000) 000-0000
My device may
trigger metal
First Name Last Name, MD
detection systems.
(000) 000-0000
Unique radiopaque symbol on the device
above the three-letter code.
UC200904855 EN © Medtronic, Inc. 2010. www.medtronic.com 04/2010
There are no radiopaque markers
on the 5076 lead. Check patient
records for lead model 5076.
Unique radiopaque symbol on the device
above the three-letter code.
Unique radiopaque helix on the 5086 leads.
• Use the patient information on the programmer. The patient information must be complete and accurate on the programmer if
this feature is to be used to determine whether the patient has a SureScan pacing system.
• Call Medtronic at 1 (877) MRI-7677 to verify the patient’s pacing system.
Confirm that the patient does not have any lead extenders, lead adaptors, or abandoned leads
Step 2: Schedule
Contact cardiology to obtain clearance documents, including:
1. SureScan Programming Order.
Schedule a health professional who will monitor patient during MRI exam.
Schedule a trained professional who will program the patient’s pacemaker in and out of SureScan mode.
Step 3: Prep Patient for Scan
Confirm a health professional, who has completed radiology SureScan training, is present
Ensure device is programmed in SureScan mode prior to the MRI examination
Step 4: C
onduct MRI Scan Using the Following Guidelines
Horizontal cylindrical bore magnet MRI system of 1.5 Tesla must be used in Normal Operating Mode
Static magnetic field with a spatial gradient ≤ 20 T/m (2,000 gauss/cm)
radient systems with maximum gradient slew rate performance per axis of ≤ 200 Teslas per meter per second (T/m/s)
G
must be used
Whole body averaged SAR must be ≤ 2W/kg, head averaged SAR must be ≤ 3.2W/kg
roper patient monitoring must be provided during the MRI scan. This includes visual and verbal contact with the patient, and
P
monitoring heart rate using instrumentation such as pulse oximetry or electrocardiography. An external defibrillator must be
available nearby during the MRI procedure.
Step 5: Manage Patient Post-Scan
Ensure a trained professional programs patient’s device back to previous settings
Brief Statement: Advisa DR MRI® and Advisa SR MRI™ SureScan® Pacing
Systems
The Advisa DR MRI and Advisa SR MRI SureScan pacing systems are MR
Conditional, and as such designed to allow patients to undergo MRI under the
specified conditions for use. A complete SureScan pacing system, which consists
of an approved combination (see http://www.mrisurescan.com/) MRI SureScan
device with SureScan lead(s), is required for use in the MRI environment. Consult
the device manuals to ensure all system components are MR Conditional.
Indications
The Advisa DR MRI SureScan Model A2DR01 and Advisa SR MRI SureScan Model
A3SR01 IPGs are indicated for use as a system. A complete SureScan pacing
system, including an Advisa DR MRI or Advisa SR MRI SureScan IPG and SureScan
lead(s), are required for use in the MRI environment.
The Advisa DR MRI and Advisa SR MRI SureScan systems are 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
The Advisa DR MRI 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
• V VI intolerance (for example, pacemaker syndrome) in the presence of persistent
sinus rhythm
• Vasovagal syndromes or hypersensitive carotid sinus syndromes
• Antitachycardia pacing (ATP) is indicated for termination of atrial
tachyarrhythmias in bradycardia patients with one or more of the above pacing
indications
Contraindications
The Advisa DR MRI and Advisa SR MRI SureScan systems are contraindicated for:
• 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 implant
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
• Asynchronous pacing is contraindicated in the presence (or likelihood) of
competition between paced and intrinsic rhythms
• Single chamber atrial pacing is contraindicated in patients with an AV
conduction disturbance
• ATP therapy is contraindicated in patients with an accessory antegrade pathway
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.
Patients and their implanted systems must be screened to meet the following
requirements:
• no lead extenders, lead adaptors, or abandoned leads
• 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
• a SureScan pacing system implanted in the left or right pectoral region
• pace polarity parameters set to Bipolar for programming MRI SureScan to On
•p
acing capture thresholds of ≤ 2.0 volts (V) at a pulse width of 0.4 milliseconds (ms)
• a lead impedance value of ≥ 200 ohms (Ω) and ≤ 1,500 Ω
• no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of
1.0 ms in patients whose device will be programmed to an asynchronous pacing
mode when MRI SureScan is on
Potential Complications
Potential complications include, but are not limited to, rejection phenomena,
erosion through the skin, muscle or nerve stimulation, oversensing, failure
to detect and/or terminate arrhythmia episodes, acceleration of tachycardia,
and surgical complications such as hematoma, infection, inflammation, and
thrombosis. Potential lead complications include, but are not limited to,
valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac
perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection,
myocardial irritability, and 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
to minimize potential complications in the MRI environment. Potential MRI
complications include, but are not limited to, lead electrode heating 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 hemodynamic collapse.
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 1 (800) 328-2518 and/or consult Medtronic’s website at
www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a
physician.
Indications
The Revo MRI SureScan Model RVDR01 IPG is indicated for use as a system
consisting of a Medtronic Revo MRI SureScan IPG implanted with two SureScan
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
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
• V VI 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.
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.
Patients and their implanted systems must be screened to meet the MRI
Conditions of Use. Do not scan patients who do not have a complete Revo MRI
SureScan pacing system consisting of a SureScan device and two SureScan
leads; patients who have previously implanted devices, or broken, abandoned or
intermittent leads; or patients who have a lead impedance value of < 200 Ω or
> 1500 Ω. Do not scan patients with a SureScan pacing system implanted in sites
other than the left or right pectoral region.
Potential Complications
Potential complications include, but are not limited to, rejection phenomena,
erosion through the skin, muscle or nerve stimulation, oversensing, failure
to detect and/or terminate arrhythmia episodes, acceleration of tachycardia,
and surgical complications such as hematoma, infection, inflammation, and
thrombosis. Potential lead complications include, but are not limited to,
valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac
perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection,
myocardial irritability, and 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
to minimize potential complications in the MRI environment. Potential MRI
complications include, but are not limited to, lead electrode heating 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 hemodynamic collapse.
Contraindications
The device is contraindicated for:
• Implantation with unipolar pacing leads
• Concomitant implantation with another bradycardia device
• Concomitant implantation with an implantable cardioverter defibrillator
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 1 (800) 328-2518 and/or consult Medtronic’s website at
www.medtronic.com.
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
Caution: Federal law (USA) restricts this device to sale by or on the order of a
physician.
www.medtronic.com
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel: (763) 514-4000
Fax: (763) 514-4879
Medtronic USA, Inc.
Toll-free: 1 (800) 328-2518
(24-hour technical support for physicians and medical professionals)
UC201005795i EN © Medtronic, Inc. 2015. Minneapolis, MN. All Rights Reserved. Printed in USA. 05/2015
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. A complete SureScan pacing system, which consists of an approved
combination (see http://www.mrisurescan.com/) MRI SureScan device with
SureScan lead(s), is required for use in the MRI environment. Consult the device
manuals to ensure all system components are MR Conditional.