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Transcript
EXAMPLE PROTOCOL
FOR PATIENT
SCANNING PROCESS
Timothy S. E. Albert, M.D.
President
CVMR Solutions, Inc.
Carmel Valley, CA
MRI SureScan™ Pacing, ICD, and CRT-D Systems
Purpose:
To define conditions that will allow a patient with a
Medtronic SureScan™ Pacing/ICD/CRT-D System to
receive an MRI.
Policy:
If a patient with a Medtronic SureScan Pacing/ICD/
CRT-D System meets the specific criteria as described in
these instructions, they may obtain, at the discretion of a
qualified physician, an MRI.
™
Definitions:
It is recognized that most traditional pacemakers/
ICD/CRT-D devices are contraindicated for MRI by the
scanner equipment labeling. However, as MR-Conditional
pacemakers/ICD/CRT-D devices enter the market, there
will be requests for scanning these patients since MRI
can be a conclusive and/or less invasive way of obtaining
important diagnostic information.
MR Specifications:
Depending on the specific SureScan™ device, the MR
must be a 1.5T or 3T cylindrical bore magnet; different
conditions of use exist for 1.5T versus 3T field strength.
Refer to Table 1 to see if a SureScan™ device is labeled
for 1.5T or 3T. See the information below for the specific
conditions of use for either 1.5T or 3T field strength for
devices covered with this protocol.
1.5T and 3T
Devices
Evera MRI™ XT DR
(DDMB1D4, DDMB1D1)
Claria MRI™Quad
(DTMA1QQ DTMA1Q1)
Evera MRI™ XT VR
(DVMB1D4)
Claria MRI™
(DTMA1D4, DTMA1D1)
Evera MRI™ S DR
(DDMC3D4, DDMC3D1)
Amplia MRI™ Quad
(DTMB1QQ, DTMB1Q1)
Visia AF MRI™ S VR
(DVFC3D4, DVFC3D1)
Amplia MRI™
(DTMB1D4, DTMB1D1)
Visia AF MRI™ VR
(DVFB1D4, DVFB1D1)
Compia MRI™ Quad
(DTMC1QQ)
Advisa MRI™ DR
(A2DR01)
Compia MRI™
(DTMC1D1)
Advisa MRI™ SR
(A3SR01)
Leads
6947: 58 and 65 cm
4574: 45 and 53 cm
6935: 58 and 65 cm
4196 (bipolar) 78, 88 cm
6947M: 55 and 62 cm
4296 (bipolar) 78, 88 cm
6935M: 55 and 62 cm
4396 (bipolar straight)
78, 88 cm
5086MRI: 45, 52, and 58 cm
4298 (quad dual cant)
78, 88 cm
5076: 35, 45, 52, 58, 65,
and 85 cm
4398 (quad straight)
78, 88 cm
4076: 35, 45, 52, 58, 65,
and 85 cm
4598 (quad S shaped)
78, 88 cm
4074: 52 and 58 cm
Pin Plug 6725
1.5T only
Devices
Revo MRI™ (RVDR01)
Table 1: Devices and leads listed per 3T and 1.5T labeling
§ Horizontal field, cylindrical bore, clinical system for
hydrogen proton imaging
§ Maximum spatial gradient of ≤ 20 T/m (2,000 gauss/cm)
§ Gradient systems with maximum gradient slew rate
performance per axis of ≤ 200 T/m/s
3T — MRI radio frequency
(RF) power
1.5T — MRI radio frequency
(RF) power
First Level Controlled
Operating Mode OR Normal
Operating Mode
Normal Operating Mode
§ Scans can be performed
without B1+RMS restriction
when the isocenter
(center of the MRI bore)
is at or superior to the C7
vertebra (see Figure 1).
§ Whole body averaged
specific absorption rate
(SAR) must be ≤ 2.0 W/kg.
§ Head SAR must be
≤ 3.2 W/kg.
§ B1+RMS must be ≤ 2.8
μT when the isocenter
is inferior to the C7
vertebra.
§ Full body scanning: No MRI Exclusion Zone
Table 2: Specific conditions of use for 1.5T and 3T.
Equipment Specifications:
Require MR compatible oximetry or ECG monitoring
devices for use in scan room (pacemaker) or for use
when SureScan™ is programmed ON (ICD/CRT-D device).
External defibrillator should be accessible in control area.
Procedure for Approval of Exam:
Before the patient is scheduled for MRI exam, the
following must occur:
§ Interpreting physician (radiologist) approves
appropriateness of exam ordered to answer the
clinical question.
§ “Pacemaker/ICD/CRT-D Device Checklist” form
(Attachment A) is started for this patient. This form
ensures all screening requirements and steps in this
procedure are followed.
§ The patient is not otherwise contraindicated for an
MRI. MRI safety screening should be completed per
center’s protocol.
§ Patient’s Cardiologist approval and order for pacer
settings (Attachment B).
Procedure:
Pre-scan (day of exam):
Ensure availability of staff to be present during the exam.
This should include the MR Technologist and a healthcare
professional (not a Medtronic employee) trained to
monitor the patient.
§ Standard MRI screening questionnaire and consents will
be obtained.
§ MRI Technologist will discuss scan parameters with the
interpreting physician. Any modifications to sequences
will be done, when possible, before the patient is in the
scan room. Special attention will be made to ensure SAR
or μT limits are not exceeded.
§ All pacemakers/ICD/CRT-D devices will be checked
by a Medtronic representative or qualified healthcare
professional. (Please note the device programmer is
NOT MRI safe).
Figure 1: 3T scan location requirements.
– If pacemaker dependency is unknown, the device will
be transiently switched to VVI at a backup rate of 30 to
assess for device dependence. Information on battery
voltage, lead capture threshold, lead impedance, and
sensing signal amplitude will be obtained and recorded
in a printout and copied to patient’s medical record.
– While the device is in the SureScan™ mode, the
tachyarrhythmia functions will be disabled (for the ICD/
CRT-D) and CRT support is also disabled; pacing mode
and rate will be set according to the cardiology order
(Attachment B).
– Healthcare provider will print report from device
programmer confirming SureScan™ mode is turned
ON and copied to patient’s medical record.
§ For patients with ICD or CRT-D systems, monitoring of
the patient by a qualified health professional is required
from the time SureScan™ is programmed ON to it
being programmed OFF. For IPG patients, monitoring
is required during the MRI scan.
§ External defibrillation should be immediately available
during the MRI procedure, and for an ICD/CRT-D
patient, the entire time SureScan™ Mode is
programmed ON.
§ Patient Monitoring:
– Pacemaker: Either prior to entering the MRI room or
once in the MRI, the MR-compatible pulse oximetry
or ECG will be attached to the patient and activated.
Accurate readings will be confirmed by a trained
healthcare professional.
– ICD/CRT-D: When SureScan™ is programmed ON,
the MR-compatible pulse oximetry or ECG will be
attached to the patient and activated. Accurate
readings will be confirmed by a trained healthcare
professional. Monitoring is required for the duration
that SureScan™ is programmed ON.
MR Scan:
§ The patient will be prepared for the exam according to
exam protocol with location guidelines followed.
§ Scanning sequences for MR-conditional pacemaker/
ICD/CRT-D may be limited or modified to respect the
respective limits per conditions of use as stated above.
§ Visual and voice communication will be maintained with
the patient by the MR tech.
§ Monitoring will be done via pulse oximetry or ECG by a
trained healthcare professional.
Post-Scan:
§ The patient will be moved from the scan room to the
control area by a qualified healthcare professional.
§ Pacemaker/ICD/CRT-D function is reassessed and
SureScan™ mode will be switched OFF and pre-scan
device settings will be restored by a Medtronic
representative or a qualified healthcare professional.
– Pacemaker: Monitor devices may be removed from
the patient after final oximetry or ECG monitor
reading is recorded and after MRI scan is completed.
– ICD/CRT-D: Monitor devices will be removed
from the patient after SureScan™ has been
programmed OFF and pre-scan device settings
have been restored.
§ Pacing capture threshold is reassessed post-scan by
a Medtronic representative or a qualified healthcare
professional to ensure the pacing parameters are
programmed adequately for the patient based on
the threshold.
Education and Training:
Per FDA labeling requirement, all cardiology and
radiology healthcare professionals present during the
MRI scan must complete an online training tutorial prior
to the scan.
§ A health professional who has completed cardiology
MRI SureScan™ training must be present during the
programming of the MRI SureScan feature.
§ A health professional who has completed radiology
MRI SureScan™ training must be present during the
MRI scan.
Training tutorials have been created for all systems
and specifically for Cardiology and Radiology health
professionals.
Please visit www.mrisurescan.com or
www.medtronicacademy.com. Search “MRI SureScan™
Training Requirement for Cardiology/Radiology.”
§ Department employees may also receive an
in-service by a Medtronic representative.
Call 1-800-Medtronic to contact your local
Medtronic representative.
Documentation:
§ Printed device rhythm and threshold reports from the
device programmer will become part of the patient’s
medical record.
§ Pre- and post-oximetry or ECG readings may
be recorded.
§ Exceptions to the performance of the routine MR
exam will be documented by the technologist or
qualified healthcare professional and added to the
patient’s chart.
CHECKLIST FORM
FOR MRI
Pacemaker/ICD/CRT-D Systems
(Page 1/2)
Patient Name:
Pre-Exam:
Initials
Received completed physician’s order for MRI?
Received completed cardiology clearance form for MRI?
Revo™ Pacemaker: Has been implanted for more than 6 weeks? (contraindication for pacemakers)
All others: Is post-lead maturation period (approximately 6 weeks)? (This is a caution, not a contraindication.) Confirm adequacy of
lead maturation with cardiology.
MRI scans during the lead maturation period (approximately 6 weeks) have not been prospectively studied by Medtronic and are
not recommended.
Revo Pacemaker: Atrial (if applicable) and right ventricular thresholds do not exceed 2.0 V at 0.4 ms.
All others: Right ventricular threshold does not exceed 2.0 V at 0.4 ms for pacemaker dependent patients. (This is a caution, not
a contraindication.)
Confirm that patient does not have any lead extenders, lead adaptors, abandoned leads, or leads that are not electrically intact.
Pacemaker/ICD/CRT-D and implanted leads conclusively identified?
(Only patients with a complete MRI SureScan™ Pacing/ICD/CRT-D System can undergo an MRI procedure.)
Note: Only CRT-D systems may have a 6725 pin plug used in the atrial port as part of an MR-Conditional system.
MRI screening questionnaire has been reviewed with patient over the phone?
Day of Exam:
In Control Room (Outside MRI Suite)
MRI Safe ECG or pulse oximeter applied to patient and assessed for accuracy; baseline blood pressure taken.
Pacemaker/ICD/CRT-D programmed into SureScan™ mode.
An external defibrillator is available in the control room.
For ICD/CRT-D: Patient ECG or oximetry monitoring will be initiated prior to SureScan™ mode being turned ON and prior to entering
the magnet. Monitoring should be continuously done by a qualified staff member until SureScan™ mode is turned OFF.
For patients with CRT-D systems, the patient receives no CRT support while SureScan™ mode is ON. Patient should be monitored
for symptoms of dizziness and shortness of breath.
In MRI Scan Room
Patient ECG or pulse oximetry will be continuously monitored during the scan by qualified staff member.
3T — MRI radio frequency (RF) power
1.5T — MRI radio frequency (RF) power
First Level Controlled Operating Mode OR Normal
Operating Mode
§ Scans can be performed without B1+RMS restriction when the
isocenter (center of the MRI bore) is at or superior to the C7
vertebra (see Figure 1).
Normal Operating Mode
§ Whole body averaged specific absorption rate (SAR) must be
≤ 2.0 W/kg.
§ Head SAR must be ≤ 3.2 W/kg.
§ B1+RMS must be ≤ 2.8 μT when the isocenter is inferior to the
C7 vertebra.
Post-Scan (Outside MRI Suite)
Post-MRI vital signs will be taken and documented.
Patient’s pacemaker/ICD/CRT-D SureScan™ setting is programed OFF (device parameters automatically restored to pre-MRI
SureScan™ configuration).
For CRT-D patients: Be sure to program MRI SureScan™ mode to OFF as soon as scan is complete to resume CRT support.
Threshold check: Update programming outputs if necessary.
CARDIOLOGY
ORDER FORM
Medtronic SureScan™ Pacing, ICD, and CRT-D
Patient Name:_______________________________________________________________________________
DOB:_________________________________________
1. Your patient has an MRI ordered. Please confirm that your patient has a Medtronic SureScan™ Pacing/ICD/CRT-D
System, with SureScan™ lead(s). (Refer to http://wwwp.medtronic.com/mrc for a current listing of Medtronic
MR-Conditional products. Note: Only CRT-D systems may have a 6725 pin plug used in the atrial port as part of an
MR-Conditional system.)
ES, my patient has a complete Medtronic SureScan™ Pacing/ICD/CRT-D System and it has been implanted longer
Y
than 6 weeks in the pectoral region (Revo MRI™ IPG) or post-lead maturation period of approximately 6 weeks
(all others).
NO, my patient does not have a complete SureScan™ IPG/ICD/CRT-D System.
2. Please confirm your patient’s leads are electrically intact. (For pacemakers: atrial and ventricular lead impedance
200-1,500 ohms. For ICDs and CRT-D devices: pacing lead 200-3,000 ohms, defibrillation lead impedance
20-200 ohms.)
YES, I confirm that my patient’s lead(s) are electrically intact.
NO, my patient’s lead(s) are not electrically intact.
3. Confirm your patient’s pacing threshold(s) do not exceed 2.0 V at 0.4 ms for Revo Pacing system, or right ventricular
pacing threshold does not exceed 2.0 V at 0.4 ms for pacemaker dependent patients for all other systems.
YES, I confirm that my patient’s threshold(s) do not exceed 2.0 V at 0.4 ms.
NO, my patient’s threshold(s) exceed 2.0 V at 0.4 ms.
4. Before the scan, your patient’s IPG/ICD/CRT-D will be placed in a SureScan mode. How would you like your patient’s
device to be programmed? Please select a pacing rate to avoid competitive pacing. (Note that post-scan, device
programming will be restored to original settings.)
DOO Pacing rate:______bpm
AOO Pacing rate:______bpm
VOO Pacing rate:______bpm
ODO or OVO
(no pacing, for patients who do not require pacing support)
Physician Signature:____________________________________________________________________________
Physician Name:_______________________________________________________________________________
Date:________________________________________________
Brief Statement
Medtronic SureScan™ Portfolio for 1.5T and 3T MR-conditional Use Medtronic SureScan™ products and systems are MR conditional, and as such are designed to allow
patients to undergo MRI under the specified conditions for use.
Pacing, ICD and CRT-D Systems: When programmed to On, the MRI SureScan™ feature allows the
patient to be safely scanned while the device continues to provide appropriate pacing. A complete
transvenous SureScan™ system, which is a SureScan™ device with appropriate SureScan™ lead(s),
is required for use in the MR environment. When a single coil SureScan™ defibrillation lead is used,
a Medtronic DF-1 pin plug must be secured in the SVC port to make a complete SureScan™ DF-1
defibrillation system. To verify that components are part of a SureScan™ system, visit http://www.
mrisurescan.com/. Any other combination may result in a hazard to the patient during an MRI scan.
Indications: The SureScan™ Advisa MRI™ and Revo MRI™ pacing systems are indicated for
rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with
increases in activity. Dual chamber SureScan™ pacing systems are also indicated for dual chamber
and atrial tracking modes in patients who may benefit from maintenance of
AV synchrony.
The SureScan™ Evera MRI™ and Visia AF MRI™ defibrillation systems are indicated to provide
ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of lifethreatening ventricular arrhythmias. In addition, the dual chamber devices are indicated for use
in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of
developing atrial tachyarrhythmias.
SureScan™ Claria/Amplia/Compia CRT-D systems are indicated for ventricular antitachycardia
pacing and ventricular defibrillation for automated treatment of life-threatening ventricular
arrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable,
optimal heart failure medical therapy if indicated, and meet any of the classifications detailed in
the specific device manuals. New York Heart Association (NYHA) Functional Class III or IV and who
have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration. Left bundle branch
block (LBBB) with a QRS duration ≥ 130 ms, left ventricular ejection fraction
≤ 30%, and NYHA Functional Class II. NYHA Functional Class I, II, or III and who have left ventricular
ejection fraction ≤ 50% and atrioventricular block (AV block) that are expected to require a high
percentage of ventricular pacing that cannot be managed with algorithms to minimize right
ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or
the urgent need for pacing should be done post-implant. Claria/Amplia only: Some CRT-D system
are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at
significant risk for developing atrial tachyarrhythmias.
Micra™ Model MC1VR01 is indicated for patients with symptomatic paroxysmal or permanent
high grade AV block in the presence of AF. It is also indicated in the absence of AF as an alternative
to dual chamber pacing, or symptomatic bradycardia-tachycardia syndrome or sinus node
dysfunction (sinus bradycardia/sinus pauses) when atrial lead placement is considered difficult,
high risk, or not deemed necessary for effective therapy.
The Reveal LINQ™ insertable cardiac monitor (ICM) is an implantable patient-activated and
automatically-activated monitoring system that records subcutaneous ECG and is indicated for
patients with clinical syndromes or situations at increased risk of cardiac arrhythmias, or patients
who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that
may suggest a cardiac arrhythmia.
Contraindications: The SureScan™ transvenous pacing systems are contraindicated for
implantation with unipolar pacing leads (Revo MRI™ only), concomitant implantation with another
bradycardia device or an implantable cardioverter defibrillator.
Micra™ IPG is contraindicated for patients who have the following types of medical devices
implanted: an implanted device that would interfere with the implant of the Micra™ device in the
judgment of the implanting physician, an implanted inferior vena cava filter, a mechanical tricuspid
valve, or an implanted cardiac device providing active cardiac therapy that may interfere with
the sensing performance of the Micra™ device or for patients who have the following conditions:
femoral venous anatomy unable to accommodate a 7.8 mm (23 French) introducer sheath or
implant on the right side of the heart (for example, due to obstructions or severe tortuosity),
morbid obesity that prevents the implanted device from obtaining telemetry communication
within ≤ 12.5 cm (4.9 in), or known intolerance to the materials listed in the Instruction for Use, or to
heparin, or sensitivity to contrast media that cannot be adequately pre-medicated.
SureScan™ defibrillation and CRT-D systems are contraindicated for patients experiencing
tachyarrhythmias with transient or reversible causes, or patients with incessant VT or VF.
For dual chamber and CRT-D devices, the device is contraindicated for patients whose primary
disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. For single chamber
devices, the device is contraindicated for patients whose primary disorder is
atrial tachyarrhythmia.
Reveal LINQ™: There are no known contraindications for the implant of the Reveal LINQ™ ICM.
However, the patient’s particular medical condition may dictate whether or not a subcutaneous,
chronically implanted device can be tolerated.
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.
Additionally, for CRT-D devices, certain programming and device operations may not provide
cardiac resynchronization. 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
for MRI:
§ SureScan™ transvenous pacing, ICD and CRT-D systems: no lead extenders, lead adaptors,
or abandoned leads present; no broken leads or leads with intermittent electrical contact as
confirmed by lead impedance history; and the system must be implanted in the left or right
pectoral region. For pacemaker-dependent patients, it is not recommended to perform an MRI
scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms.
A higher pacing capture threshold may indicate an issue with the implanted lead. 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. It
is not recommended to perform MRI scans during the lead maturation period
(approximately 6 weeks).
§ Pacemaker specific: pace polarity parameters set to Bipolar for programming MRI SureScan™ to
On (Advisa MRI™ only); or a SureScan™ pacing system with a lead impedance value of ≥ 200 Ω and
≤ 1,500 Ω. Revo MRI™ patients must have pacing capture thresholds of ≤ 2.0 V at a pulse width of
0.4 ms and a SureScan™ pacing system that has been implanted for a minimum of
6 weeks.
§ Micra™: no abandoned leads are present; device is operating within the projected service life;
pacing amplitude is ≤ 4.5 V at the programmed pulse width; no diaphragmatic stimulation is
observed when MRI SureScan™ is programmed to On.
MR Scanning Conditions:
§ Transvenous system patients may be scanned using a horizontal field, cylindrical bore, clinical
1.5T or 3T MRI system for hydrogen proton imaging, maximum spatial gradient ≤ 20 T/m,
and maximum gradient slew rate performance per axis ≤ 200 T/m/s. 1.5T scanners must be
operated in Normal Operating Mode (whole body averaged specific absorption rate (SAR) ≤ 2.0
W/kg, head SAR ≤ 3.2 W/kg). 3T scanners must be operated in First Level Controlled Operating
Mode or Normal Operating Mode. B1+RMS must be ≤ 2.8 μT when the isocenter (center of the
bore) is inferior to the C7 vertebra. Scans can be performed without B1+RMS restriction when the
isocenter is at or superior to the C7 vertebra. Revo MRI™ pacemakers can only be scanned using
1.5T systems.
§ Micra™ and Reveal LINQ™ patients may be scanned using a horizontal field, cylindrical bore,
clinical 1.5T or 3T MRI system for hydrogen proton imaging, maximum spatial gradient
≤ 25 and T/m, and maximum gradient slew rate performance per axis ≤ 200 T/m/s. The Whole
Body Specific Absorption Rate (SAR) as reported by the MRI equipment must be ≤4.0 W/kg; the
head SAR as reported by the MRI equipment must be ≤ 3.2 W/kg.
§ Reveal LINQ™: Do not use local transmit coils on the chest, trunk, or shoulder region.
§ For all SureScan™ pacing systems, proper patient monitoring must be provided during the
MRI scan. For SureScan™ defibrillation and CRT-D systems, continuous patient monitoring
is required while MRI SureScan™ is programmed to On. Do not scan a patient without first
programming MRI SureScan™ to On and do not leave the device in MRI SureScan™ mode after
the scan is complete. While MRI SureScan™ is programmed to On, arrhythmia detection and
therapies are suspended, leaving the patient at risk of death from untreated spontaneous
tachyarrhythmia. In addition, if the device is programmed to an asynchronous pacing mode,
arrhythmia risk may be increased.
Potential Complications: Potential complications include, but are not limited to, rejection
phenomena, device migration, infection, or erosion through the skin. Potential complications
associated with cardiac rhythm devices include muscle or nerve stimulation, oversensing,
failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical
complications such as hematoma, 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.
Other potential complications related to Micra™ are access site hematoma, AV fistulae, and vessel
spasm, 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 MR-induced stimulation on leads
resulting in continuous capture, VT/VF, and/or hemodynamic collapse. Potential complications
of the Reveal LINQ™ device include, but are not limited to, device rejection phenomena (including
local tissue reaction), device migration, infection, and erosion through the skin.
See the appropriate product MRI SureScan™ Technical Manual before performing an MRI Scan
and see the device manuals for detailed information regarding the implant procedure, indications,
contraindications, warnings, precautions, and potential complications/adverse events. For
further information, call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.
medtronic.com or www.mrisurescan.com.
Medtronic
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Minneapolis, MN 55432-5604
USA
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Worldwide: +1.763.514.4000
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