Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party
trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered
trademarks of a Medtronic entity in the United States and/or in other countries.
5 Warnings, precautions, and potential adverse events 6
5.1 Warnings and precautions to ensure intended device function 6
5.2 Potential adverse events 10
6 Patient selection and treatment 10
6.1 Select the pacing mode 10
6.2 Patient counseling information 11
6.3 Patient manual 11
6.4 Patient ID card 11
7 Clinical studies 11
7.1 Adverse events and clinical trial data 11
8 Implant procedure 12
8.1 Verify sufficient device longevity 12
8.2 Verify lead and connector compatibility 13
8.3 Test the lead system 14
8.4 Connect the leads to the device 14
8.5 Test the device operation 15
8.6 Position and secure the device 15
8.7 Program the device 16
8.8 Replace a device 16
9 Potential complications and emergency pacing 17
9.1 Potential complications 17
9.2 Emergency pacing 18
10 Magnet operation and Elective Replacement Indicator (ERI) 18
11 Device parameters 19
11.1 Shipping, nominal, and electrical reset parameters 19
11.2 Programmable parameters 24
11.3 Automatic and clinician-selectable diagnostics 30
11.4 Nonprogrammable parameters 32
12 Device information 33
12.1 Physical characteristics 33
12.2 Electrical specifications 34
12.3 Projected service life 35
12.4 Prolonged service period 36
12.5 Feature summary 37
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1 System overview
1.1 Introduction
About this manual – This document is primarily an implant manual. Regular patient follow-up sessions should be
scheduled after implant. Follow-up procedures such as monitoring battery measurements and confirming therapy
parameters are described in the product documentation that is included with the software that supports this device.
To obtain additional copies of product documentation, go to www.medtronic.com/manuals or contact a Medtronic
representative.
This manual describes the Medtronic Attesta L DR MRI SureScan dual chamber, multiprogrammable,
rate-responsive implantable pulse generator (IPG) bipolar/unipolar Model ATDRL1, also referred to as a
pacemaker.
The following manuals and documents also contain information about the device:
MRI technical manual – This manual provides MRI-specific procedures and warnings and precautions.
Programming guide – This manual contains device programming procedures and patient follow-up guidelines.
The programming guide applies to multiple models within a device family.
Reference manual – This manual contains feature descriptions, troubleshooting information, and other device
reference information. The reference manual applies to multiple models within a device family.
Radio regulatory compliance information – This document provides compliance information related to the
radio components of the device.
Explanation of symbols – This document defines the symbols that may appear on the device package. Refer to
the package label to see which symbols apply specifically to this device.
Medical Procedure and EMI Warnings and Precautions Manual for Health Care Professionals – This
manual provides warnings, precautions, and guidance for health care professionals who perform medical
therapies and diagnostic procedures on cardiac device patients. The manual also provides patient education
information related to sources of electromagnetic interference (EMI) at home, at work, and in other environments.
1.2 System description
The Medtronic Attesta L DR MRI SureScan model ATDRL1 dual chamber implantable pulse generator (IPG) is a
multi-programmable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual
chamber rate-responsive bradycardia pacing.
The MRI SureScan feature permits a mode of operation that allows a patient with a SureScan system to be safely
scanned by an MRI machine while the device continues to provide appropriate pacing. When programmed to On,
MRI SureScan operation disables arrhythmia detection, magnet mode, and all user-defined diagnostics. Before
performing an MRI scan, refer to the MRI technical manual.
The users of this device include medical professionals (physicians, nurses, technicians, and their supporting staff)
trained in surgery, cardiology, radiology, and magnetic resonance (MR) technology and able to implement the
procedures documented in the instructions for use for this device.
Rate response – Rate response is controlled through an activity-based sensor.
Programmer and software – Use the appropriate Medtronic programmer and software to program this device.
Programmers from other manufacturers are not compatible with Medtronic devices but will not damage Medtronic
devices.
Contents of sterile package – The package contains 1 implantable pulse generator and 1 torque wrench used
to tighten setscrews.
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1.2.1 Usage environments
The device is intended to be used in the following environments and conditions:
• The device will be implanted in a properly equipped, staffed, and sterile surgical environment. Implant will take
place under standard surgical protocols and in the patient population for which the device is indicated.
• Post-surgical patient and device follow-up care will take place in a properly equipped and staffed cardiology
clinic or office.
• MRI procedures for patients with this device will take place in a properly equipped and staffed MR facility, and
in consideration of the conditions and requirements described in Chapter 4, MRI conditions for use,page 5.
• After having an implant, patients may resume their lives at home, at work, and in other environments with
consideration of the advice and restrictions documented in the Medical Procedure and EMI Warnings and
Precautions Manual for Health Care Professionals and in the patient literature.
2 Indications
The Medtronic Attesta L DR MRI SureScan model ATDRL1 implantable pulse generator (IPG) is indicated for use
in patients who may benefit from rate responsive pacing to support cardiac output during varying levels of activity.
This device is indicated for use in patients who have experienced one or more of the following conditions:
• 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
• vasovagal syndromes or hypersensitive carotid sinus syndromes
This device is also indicated for use in patients who may benefit from maintenance of AV synchrony through the
use of dual chamber modes and atrial tracking modes. Dual chamber modes are specifically indicated for
treatment of conduction disorders that require restoration of both rate and AV synchrony. Dual chamber modes are
indicated for use in patients who have experienced one or both of the following conditions:
• various degrees of AV block
• VVI intolerance (for example, pacemaker syndrome) in the presence of a persistent sinus rhythm
3 Contraindications
The Medtronic Attesta L DR MRI SureScan model ATDRL1 implantable pulse generator (IPG) is contraindicated
for the following applications:
• Dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias
• Asynchronous pacing in the presence or likelihood of competition between paced and intrinsic rhythms
• Use of implantable cardioverter defibrillators (ICD) with an IPG in unipolar configuration. Pacing in the unipolar
configuration may cause the ICD either to provoke inappropriate therapy or to withhold appropriate therapy.
4 MRI conditions for use
A complete SureScan pacing system is required for use in the MR environment. A complete SureScan
pacing system includes a SureScan device with Medtronic SureScan leads. 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.
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Warning: Do not scan a patient without first programming the MRI SureScan mode to On. Scanning the patient
without programming the MRI SureScan mode to On may result in patient harm or damage to the SureScan pacing
system.
Note: The MRI SureScan mode cannot be programmed to On if the device is recommended for replacement.
Cardiology requirements
Patients and their implanted systems must be screened to meet the following requirements:
• The patient has no implanted lead extenders, lead adaptors, or abandoned leads.
• The patient has no broken leads or leads with intermittent electrical contact, as confirmed by lead impedance
history.
• The SureScan pacing system is implanted in the left or right pectoral region.
• The pace polarity parameters are set to Bipolar for programming the MRI SureScan mode to On.
• The SureScan device is operating within the projected service life.
• For patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan
mode is programmed to On, no diaphragmatic stimulation is present when the paced leads have a pacing
output of 5.0 V and a pulse width of 1.0 ms.
Caution: 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 for pacemaker-dependent patients. A higher pacing capture threshold may indicate
an issue with the implanted lead.
Notes:
• For radiology requirements, refer to the MRI technical manual.
• Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and
precautions.
Patient monitoring and rescue requirements
• Continuous patient monitoring is required during the MRI scan.
• In the event that patient rescue is required, an external defibrillator must be immediately available.
Training requirements
• A health professional who has completed cardiology SureScan training must be present during the
programming of the MRI SureScan feature.
• A health professional who has completed radiology SureScan training must be present during the MRI scan.
5 Warnings, precautions, and potential adverse events
Before performing an MRI scan, refer to the Medtronic MRI technical manual for MRI-specific warnings
and precautions.
5.1 Warnings and precautions to ensure intended device function
5.1.1 Device operation
Accessories – Use this device only with accessories, parts subject to wear, and disposable items that have been
tested to technical standards and found safe by an approved testing agency.
Atrial Capture Management – Atrial Capture Management does not program atrial outputs above 5.0 V or
1.0 ms. If the patient needs a pacing output higher than 5.0 V or 1.0 ms, manually program the Amplitude and Pulse
Width. If a lead dislodges partially or completely, Atrial Capture Management may not prevent loss-of-capture.
Crosstalk – Crosstalk may cause the device to self-inhibit, which results in no pacing. Program Ventricular Safety
Pacing to On to prevent inhibition due to crosstalk.
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Device status indicators – If any of the device status indicators (for example, Electrical Reset) are displayed on
the programmer after interrogating the device, inform a Medtronic representative immediately. If these device
status indicators are displayed, therapies may not be available to the patient.
Effects of myopotential sensing in unipolar sensing configurations – In unipolar sensing configurations, the
device may not distinguish myopotentials from cardiac signals. This may result in a loss of pacing due to inhibition.
Also, unipolar atrial sensing in atrial tracking modes can result in elevated ventricular pacing rates. To address
these situations, the device may be programmed to be less sensitive (using higher sensitivity values). However,
the sensitivity level must be balanced against the potential to undersense true cardiac signals. Typically, this
balance is easily attained for ventricular sensing using sensitivity values around 2.8 mV, but it may be difficult to
attain for atrial sensing because of the smaller P-wave amplitudes.
Electrical isolation during implant – Do not allow the patient to have contact with grounded electrical equipment
that might produce electrical current leakage during implant. Electrical current leakage may induce
tachyarrhythmias that may result in the patient’s death.
Electrical reset – Electrical reset can be caused by exposure to temperatures below –18°C (0°F) or strong
electromagnetic fields. Advise patients to avoid strong electromagnetic fields. Observe temperature storage limits
to avoid exposure of the device to cold temperatures. If a partial reset occurs, pacing resumes in the programmed
mode with many of the programmed settings retained. If a full reset occurs, the device operates in VVI mode at
65 ppm. Electrical reset is indicated by a programmer warning message that is displayed immediately upon
interrogation. To restore the device to its previous operation, it must be reprogrammed.
See Section 11.1, Shipping, nominal, and electrical reset parameters, page 19 for a complete list of preserved
and changed partial and full reset parameters.
Epicardial leads – Epicardial leads have not been determined appropriate for use with the Ventricular Capture
Management feature. Program Ventricular Capture Management to Off if implanting an epicardial lead. Note:
Epicardial leads compromise the ability to safely perform an MRI scan on the MRI SureScan pacing system.
Patients with epicardial leads are contraindicated for an MRI scan.
Extended Upper Tracking Rate – When programming Upper Tracking Rates of 190, 200, or 210 ppm, be careful
to ensure that these rates are appropriate for the patient. The Upper Tracking Rates of 190, 200, and 210 ppm are
intended primarily for use in pediatric patients.
False bipolar pathway with unipolar lead – When implanting a unipolar lead, ensure that the tip setscrew is
properly engaged and that all electrical contacts are sealed to prevent electrical leakage. Electrical leakage may
cause the device to inappropriately identify a unipolar lead as bipolar, resulting in loss of output.
Hex wrench – Do not use a blue-handled or right-angled hex wrench. These wrenches have torque capabilities
greater than the lead connector can tolerate. The setscrews may be damaged by excessive torque.
Lead compatibility – Although Medtronic device connector modules conform to International Connector
Standards, this device has not been tested for use with non-Medtronic leads. The known potential adverse
consequences of using such a combination may include undersensing of cardiac activity, failure to deliver
necessary therapy, or an intermittent electrical connection.
Note: Bipolar or unipolar leads may be used with the Attesta L DR MRI SureScan model ATDRL1 device, but if
leads other than bipolar MRI SureScan leads are used, the system is contraindicated for MRI scans.
Lead connection – Consider the following information when connecting the leads and the device:
• Cap abandoned leads to avoid transmitting electrical signals.
• Plug any unused lead ports to protect the device.
• Verify lead connections. Loose lead connections may result in inappropriate sensing and failure to deliver
arrhythmia therapy.
Muscle stimulation – Muscle stimulation (for example, due to high-output unipolar pacing) may result in pacing
at rates up to the Upper Sensor rate in rate responsive modes.
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Pacing and sensing safety margins – Consider lead maturation when selecting pacing amplitudes, pacing
pulse widths, and sensing levels. Loss of capture may occur if lead maturation is not considered when selecting
settings.
PMT intervention – Even with the feature turned to On, PMTs may still require clinical intervention such as
pacemaker reprogramming, magnet application, drug therapy, or lead evaluation.
Rate-response modes – Rate response modes that are programmed above the programmed Lower Rate may
not be tolerated by some patients.
Sensitivity setting – Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before
changing the sensitivity threshold to its most sensitive setting of 0.18 mV. When susceptibility to interference is
tested under the conditions specified in standards ISO 14708-2:2012 clause 27 and ISO 14117:2012, the device
may sense the interference if the sensitivity threshold is programmed to any programmable sense threshold.
Shipping values – Do not use shipping values or nominal values for pacing amplitude and sensitivity without
verifying that the values provide adequate safety margins for the patient.
Single chamber atrial modes – Do not program single chamber atrial modes for patients with impaired AV nodal
conduction. Ventricular pacing does not occur in these modes.
Slow retrograde conduction – Slow retrograde conduction may induce pacemaker-mediated tachycardia
(PMT) when the VA conduction time is greater than 400 ms. Programming PMT intervention may help prevent PMT
when the VA conduction time is less than 400 ms.
Tip contacts – When implanting a device, ensure that the tip setscrews are properly engaged and all electrical
contacts are sealed to prevent possible electrical leakage. Also, ensure that electrical contacts are sealed when
using lead extenders or adaptors. Electrical leakage may cause a loss of output. Note: Lead extenders or lead
adaptors compromise the ability to safely perform an MRI scan on the SureScan pacing system. Patients with lead
extenders or lead adaptors are contraindicated for an MRI scan.
Twiddler’s syndrome – Twiddler’s syndrome, i.e., patient manipulation of the device after implant, may cause the
pacing rate to increase temporarily if the pacemaker is programmed to a rate responsive mode.
Ventricular Capture Management – Ventricular Capture Management does not program ventricular outputs
above 5.0 V or 1.0 ms. If the patient needs a pacing output higher than 5.0 V or 1.0 ms, manually program Amplitude
and Pulse Width. If a lead dislodges partially or completely, Ventricular Capture Management may not prevent
loss-of-capture.
5.1.2 Device system warnings and precautions for pacemaker-dependent patients
Asynchronous pacing modes – Asynchronous pacing modes (DOO, VOO, AOO) disable sensing. It is not
appropriate to permanently program these pacing modes for pacemaker-dependent patients.
Diagnostic modes – Do not program diagnostic modes (ODO, OVO, and OAO) for pacemaker-dependent
patients. These modes disable pacing. Instead, use the programmer’s inhibit function for brief interruption of
outputs.
Inhibit function – Use caution when using the programmer to inhibit pacing. The patient is without pacing support
when pacing is inhibited.
Polarity override – Do not override the polarity verification prompt with bipolar polarity when a unipolar lead is
connected. Overriding the polarity verification prompt results in no pacing output.
Threshold Margin Test (TMT) and loss of capture – Be aware that loss of capture during a TMT at a 20%
reduction in amplitude indicates an inadequate stimulation safety margin.
Ventricular Safety Pacing – Always program Ventricular Safety Pacing (VSP) to On for pacemaker-dependent
patients. Ventricular Safety Pacing prevents ventricular asystole due to inappropriate inhibition of ventricular
pacing caused by oversensing.
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5.1.3 External devices during implant
External defibrillation equipment – Keep external defibrillation equipment nearby for immediate use whenever
arrhythmias are possible or intentionally induced during device testing, implant procedures, or post-implant
testing.
External pacing instrument – Keep an external pacing instrument available for immediate use. When the lead
is disconnected, pacemaker-dependent patients are without pacing support.
5.1.4 Handling and storage instructions
Follow these guidelines when handling or storing the device.
Device storage – Store the device in a clean area, away from magnets, kits containing magnets, and sources of
electromagnetic interference. Exposing the device to magnets or electromagnetic interference may damage the
device.
Storage temperature – Store and transport the package between –18°C and +55°C (0°F and 131°F). Device
reset may occur at temperatures below –18°C (0°F). Device longevity may decrease and performance may be
affected at temperatures above +55°C (131°F).
Use by date – Do not implant the device after the “Use by” date on the package label. Battery longevity may be
reduced.
Checking and opening the package – Before opening the sterile package tray, visually check for any signs of
damage that might invalidate the sterility of the package contents.
If the package is damaged – The device packaging consists of an outer tray and inner tray. Do not use the device
or accessories if the outer packaging tray is wet, punctured, opened, or damaged. Return the device to Medtronic
because the integrity of the sterile packaging or the device functionality may be compromised. This device is not
intended to be resterilized.
If the package information is damaged – If any information on the outer package or the sterile package is
defaced or damaged so that you cannot read it, notify a Medtronic representative so that the device can be
replaced.
If the printed manual is illegible – If this manual is supplied in its printed form and any part of it is illegible, contact
a Medtronic representative to request a replacement manual.
Dropped device – Do not implant the device if it is dropped on a hard surface from a height of 30 cm (12 in) or more
after it is removed from its packaging.
Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. This product
is for single use only and is not intended to be resterilized.
For single use only – Do not resterilize and reimplant an explanted device that has been contaminated by contact
with body fluids.
Device temperature – Allow the device to reach room temperature before it is programmed or implanted. Device
temperature above or below room temperature may affect initial device function.
5.1.5 Explant and disposal
Consider the following information related to device explant and disposal:
• Explant the implantable device postmortem. In some countries, explanting battery-operated implantable
devices is mandatory because of environmental concerns; please check the local regulations. In addition, if
subjected to incineration or cremation temperatures, the device may explode.
• Medtronic implantable devices are intended for single use only. Do not resterilize and reimplant explanted
devices.
• Contact Medtronic for Return Mailer Kits to return explanted devices for analysis and disposal. See the back
cover for addresses. Note: Disposal of explanted devices or leads is subject to local, state, and federal
regulations.
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5.2 Potential adverse events
The following known potential adverse events are associated with the use of pacing systems:
• Air embolism
• Allergic reaction
• Bleeding
• Body rejection phenomena including local tissue rejection
• Cardiac dissection
• Cardiac perforation
• Cardiac tamponade
• Chronic nerve damage
• Death
• Embolism
• Endocarditis
• Erosion of the device and lead through the skin
• Excessive fibrosis
• Extrusion
• Fibrillation or other arrhythmias
• Fluid accumulation
• Formation of cysts
• Heart block
• Heart wall rupture
• Hematoma/seroma
• Inappropriate acceleration of arrhythmias
• Infection
• Keloid formation
• Lead abrasion and discontinuity
• Lead migration/dislodgment
• Muscle and nerve stimulation
• Myocardial damage
• Myocardial irritability
• Myopotential sensing
• Pericardial effusion
• Pericardial rub
• Pneumothorax
• Threshold elevation
• Thromboemboli
• Thrombosis
• Tissue damage due to heating of device or lead (during an MRI procedure)
• Transvenous lead-related thrombosis
• Valve damage
• Venous occlusion
• Venous perforation
• Vein wall rupture
6 Patient selection and treatment
6.1 Select the pacing mode
TherapyGuide offers a simple, clinically focused method where the programmer suggests parameter values
based on selected clinical conditions. Examples of clinical conditions include the condition of the sinus node and
the quality of AV conduction. The rationale for suggested parameter values, including pacing mode, is based on
clinical studies, literature, current practice, and the consensus of physicians.
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To navigate to the TherapyGuide Rationale window, perform the following steps:
1. Interrogate the pacemaker following implant.
2. Tap Params. The Parameters - Therapy screen displays.
3. Tap TherapyGuide > Rationale…. The Rationale window displays.
4. Tap Close twice to return to the Parameters - Therapy screen.
Note: Refer to the programming guide for detailed information on using TherapyGuide to inform your programming
decisions.
6.2 Patient counseling information
The clinician may wish to discuss the following topics with the patient before discharge:
• Review the signs and symptoms that should be reported to the patient’s physician.
• Review instructions to the patient concerning physical activity.
• Advise the patient on the frequency of follow-up care.
• Inform the patient of cautions regarding sources of electromagnetic interference (EMI).
• Educate the patient about the consequences of device manipulation (Twiddler’s syndrome).
6.3 Patient manual
A patient manual is packaged with the device. The patient manual contains information for the patient, the patient’s
family, and other interested people. Discuss the information in this manual with concerned individuals so they are
familiar with the operation of the device. To obtain additional copies of the patient manual, contact a Medtronic
representative, or call the toll-free phone number on the back cover of the patient manual.
6.4 Patient ID card
A temporary patient ID card is packaged with each device. A permanent patient ID card is mailed to the patient
within a month after Medtronic receives the Device Registration Form. Advise the patient to always carry the
patient ID card.
7 Clinical studies
7.1 Adverse events and clinical trial data
Information regarding clinical studies and adverse events related to this device is available at
www.medtronic.com/manuals.
The following clinical studies are related to this device:
Advisa DR MRI system study – This clinical study, which evaluated the safety and efficacy of the Advisa DR MRI
SureScan pacing system in the clinical magnetic resonance imaging (MRI) environment, provides support for the
MRI SureScan feature. This study supports removal of the C1-T12 positioning restriction, so that any region of the
body can be scanned when the MR Conditions for Use are followed.
Atrial Capture Management (ACM) study – This clinical study, which evaluated the Atrial Capture Management
feature in EnPulse pacemakers, provides support for the Atrial Capture Management feature in
Attesta L DR MRI SureScan model ATDRL1 devices.
Atrial Fibrillation Symptoms Mediated by Pacing to Mean Rates (AF SYMPTOMS) – This study evaluated
the long-term effects of Conducted AF Response in patients with atrial fibrillation and intact atrioventricular (AV)
conduction. It provides support for the Conducted AF Response feature in Attesta L DR MRI SureScan model
ATDRL1 devices. Note that the Ventricular Response Pacing (VRP) feature mentioned in the study is called
Conducted AF Response in the Attesta L DR MRI SureScan model ATDRL1 devices.
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Atrial Septal Pacing Efficacy Trial (ASPECT) – This clinical study, which evaluated the safety and efficacy of the
Medtronic AT500 DDDRP Pacing System devices, provides support for the atrial intervention pacing therapies.
EnRhythm clinical study – This clinical study, which evaluated the safety and efficacy of the EnRhythm model
P1501DR devices, provides support for Managed Ventricular Pacing (MVP) in the Attesta L DR MRI SureScan
model ATDRL1 devices.
GEM III DR model 7275 MVP study – This clinical study, which evaluated the performance of MVP mode pacing
in the GEM III DR model 7275 devices, provides support for MVP mode in the Attesta L DR MRI SureScan model
ATDRL1 devices.
Kappa 700 clinical study – This study, which evaluated the safety and clinical performance of the Kappa 700
pacemakers, provides support for the Right Ventricular Capture Management feature and other bradycardia
pacing features.
Marquis MVP download study – This clinical study, which evaluated the performance of MVP mode pacing in
the Marquis DR model 7274 devices, provides support for MVP mode in the Attesta L DR MRI SureScan model
ATDRL1 devices.
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT) – This clinical study evaluated
the efficacy of the intervention pacing therapies on symptomatic AT/AF episodes in subjects where the lead was
placed in the Bachmann’s Bundle region. The results of the study failed to demonstrate effectiveness of the
intervention pacing therapies. Evaluation of the RESPECT study data indicated that the intervention pacing
features did not significantly reduce the rate of symptomatic AT/AF episodes and these results did not confirm the
findings from previous trials. The pre-specified subgroups were tested for therapeutic effect, but none had results
suggesting benefit. When intervention pacing algorithms were programmed ON, atrial pacing percentage
increased by 18.1% (P<0.001) with a modest, yet statistically significant, increase in mean heart rate of 2.4 beats
per minute (P<0.001).
Revo MRI SureScan pacing system clinical study – This clinical study, which evaluated the safety and efficacy
of the EnRhythm MRI SureScan pacing system in the clinical magnetic resonance imaging (MRI) environment,
provides support for the MRI SureScan feature. This study was conducted with the C1 – T12 MRI scan exclusion
zone in place.
SureScan Pacing System Post-Approval Study – This clinical study, which evaluated safety and performance
of approved systems in a magnetic resonance imaging (MRI) environment, provides support for the MRI SureScan
feature.
8 Implant procedure
Proper surgical procedures and sterile techniques are the responsibility of the physician. The following procedures
are provided for information only. Each physician must apply the information in these procedures according to
professional medical training and experience.
For information about replacing previously implanted devices, see Section 8.8, Replace a device, page 16
8.1 Verify sufficient device longevity
Complete the following steps prior to opening the pacemaker box:
1. Check the use-by date printed on the package.
2. Place the programmer head over the box and start the application.
3. Interrogate the device.
4. Confirm the battery voltage is at least 2.75 V at room temperature using the Programming Guide instructions
for viewing battery status.
5. Contact your Medtronic representative if the use-by date or battery voltage is out of range.
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8.2 Verify lead and connector compatibility
Ø 1.93 mm (2x)
Ø 3.5 mm (2x)
19.1 mm (2x)
25.2 mm (2x)
A complete SureScan pacing system is required for use in the MR environment. A complete SureScan
pacing system includes a SureScan device with Medtronic SureScan leads. 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.
Warning: Verify lead and connector compatibility before using a lead with this device. Using an incompatible lead
may damage the connector, result in electrical current leakage, or result in an intermittent electrical connection.
A lead adaptor may be needed to connect the lead to the device. Contact a Medtronic representative for questions
about lead adaptor compatibility.
Note: Bipolar or unipolar leads may be used with the Attesta L DR MRI SureScan model ATDRL1 device, but if
leads other than bipolar MRI SureScan leads are used, the system is contraindicated for MRI scans.
Note: Lead adaptors compromise the ability to safely scan the SureScan pacing system during an MRI scan.
Patients with lead adaptors are contraindicated for an MRI scan.
Select a compatible lead. Refer to the following table.
Table 1. Lead and connector compatibility
Connector portPrimary leads
A, VIS-1a bipolar and IS-1 unipolar
a
IS-1 refers to the international standard ISO 5841-3.
8.2.1 Connector dimensions
The following figure provides connector dimensions for the Attesta L DR MRI SureScan model ATDRL1 device.
Figure 1. Attesta L DR MRI SureScan model ATDRL1 connector dimensions
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8.3 Test the lead system
For lead testing procedures, refer to the technical manual supplied with the implant support instrument.
8.4 Connect the leads to the device
Warning: Verify that the lead connections are secure. Loose lead connections may result in inappropriate sensing,
which can cause inappropriate arrhythmia therapy or a failure to deliver arrhythmia therapy.
Caution: Use only the wrench supplied with the device. The wrench is designed to prevent damage to the device
from overtightening a setscrew.
Connect the leads to the device by performing the following steps:
1. Insert the wrench into a grommet on the connector port.
a. Check that the setscrew is retracted from the connector port. If the connector port is obstructed, retract
the setscrew to clear it. Do not disengage the setscrew from the connector block, see Figure 2.
Figure 2. Preparing the connector port setscrew
1 IS-1 connector port, A
2 IS-1 connector port, V
b. Leave the wrench in the grommet until the lead is secure. This allows a pathway for venting trapped air
when the lead is inserted, see Figure 3.
Figure 3. Wrench in the grommet
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2. Push the lead connector pin into the connector port until the connector pin is visible in the lead viewing area.
Sterile water may be used as a lubricant. Sealant is not required.
Figure 4. Inserting a lead into the device
1 Model ATDRL1 IS-1 leads — The lead pins are visible at the end of the viewing area.
3. Tighten the setscrew by turning the wrench to the right until the wrench clicks.
4. Repeat these steps for each lead.
5. Gently pull on the lead to confirm the connection.
8.5 Test the device operation
Warning: Keep an external pacing instrument available for immediate use. When the leads are disconnected,
pacemaker-dependent patients are without pacing support.
Verify device operation by reviewing an ECG. If pacing and sensing are not adequate, perform one or more of the
following tasks for one or both leads, as needed:
• Verify that the pacing threshold margin is adequate at the time of implant (and at each patient follow-up
session).
• Verify the connection of the lead to the device. Confirm that the lead connector pin appears in the viewing area.
• Disconnect the lead from the device. Visually inspect the lead connector and lead. Replace the lead if
necessary.
• Retest the lead. Inadequate electrical signals may indicate lead dislodgment. If necessary, reposition or
replace the lead.
8.6 Position and secure the device
Note: Proper device placement can facilitate lead wrap and prevent muscle stimulation and device migration. The
device may be implanted in right or left pectoral sites. Either side of the device may face the skin to facilitate excess
lead wrap.
Note: Implant the device within 5 cm (2 in) of the surface of the skin to optimize post-implant ambulatory
monitoring.
1. Verify that each lead connector pin or plug is fully inserted into the connector port and that all setscrews are
tight.
2. To prevent twisting of the lead body, rotate the device to loosely wrap the excess lead length. Do not kink the
lead body.
3. Place the device and leads into the surgical pocket.
4. Suture the device securely within the pocket. Use non-absorbable sutures. Secure the device to minimize
post-implant rotation and migration. Use a surgical needle to penetrate the suture hole on the device.
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Figure 5. Location of suture hole
1 Suture hole
5. Suture the pocket incision closed.
8.7 Program the device
1. If unipolar leads are implanted, you may want to manually complete the Implant Detection process.
a. Tap Params.
b. Program the Pace Polarity and Sense Polarity parameters to Unipolar.
Note: If the patient experiences muscle stimulation while being paced in the unipolar configuration,
reduce the amplitude or narrow the pulse width. Maintain adequate stimulation safety margins.
c. Tap Additional Features… and program the Implant Detection parameter to Off/Complete.
2. Verify that the pacing and detection parameters are programmed to values that are appropriate for the patient.
3. Enter the patient’s information in the Patient Information screen.
Note: Use the Patient Information screen to document complete information about the implanted leads and
other hardware implanted in the patient, including abandoned devices, leads, lead extenders or adaptors.
This information will be used in the future if the patient needs to be evaluated for an MRI scan. For more
information, see the programming guide.
8.8 Replace a device
To retain the ability to safely scan the SureScan pacing system during MRI scans, the MRI conditions for use in
Chapter 4, MRI conditions for use, page 5 must be followed. Refer to the Medtronic MRI technical manual for
additional information.
Warning: Bipolar or unipolar leads may be used with the Attesta L DR MRI SureScan model ATDRL1 device, but
if leads other than bipolar SureScan leads are used, the system is not approved for MRI scans. Before performing
an MRI scan, refer to the Medtronic MRI technical manual for additional information.
Warning: Abandoned leads or previously implanted non-MRI labeled leads compromise the ability to safely scan
the SureScan pacing system during future MRI scans. When implanting a SureScan pacing system, consider the
risks associated with removing previously implanted leads before removing the leads to maintain the ability to
safely scan the SureScan pacing system. Refer to the Medtronic MRI technical manual for additional information.
Warning: Keep an external pacing instrument available for immediate use. When the leads are disconnected,
pacemaker-dependent patients are without pacing support.
Note: Any unused leads that remain implanted must be capped with a lead pin cap to avoid transmitting electrical
signals. Any capped or unused leads are considered abandoned leads in the MRI conditions for use, and their
presence will contraindicate the system for MRI scanning. Contact your Medtronic representative for information
about lead pin caps.
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8.8.1 How to explant and replace a device
1. Program the device to a mode that is not rate responsive to avoid potential rate increases while explanting the
device.
2. Dissect the leads and the device free from the surgical pocket. Do not nick or breach the lead insulation.
3. Use a torque wrench to loosen the setscrews in the connector port.
4. Gently pull the leads out of the connector port.
5. Evaluate the condition of the leads (see Section 8.3, Test the lead system, page 14). Replace the leads if the
electrical integrity is not acceptable or if the lead connector pin is pitted or corroded. If you explant the lead,
return it to Medtronic for analysis and disposal.
6. Connect the leads to the replacement device (see Section 8.4, Connect the leads to the device, page 14).
Note: Lead adaptors may be needed to connect the leads to the replacement device (see Section 8.2, Verify
lead and connector compatibility, page 13). Contact a Medtronic representative for questions about
compatible lead adaptors.
Note: Lead adaptors compromise the ability to safely perform an MRI scan on the SureScan pacing system
in the future. Patients with lead adaptors are contraindicated for an MRI scan.
7. Use the replacement device to evaluate stimulation thresholds and sensing potentials.
8. After confirming acceptable electrical measurements, place the device in the surgical pocket and suture the
pocket incision closed.
9. Contact Medtronic for Return Mailer Kits to return explanted devices for analysis and disposal. See the back
cover for addresses. Note: Disposal of explanted devices or leads is subject to local, state, and federal
regulations.
9 Potential complications and emergency pacing
9.1 Potential complications
The pacemaker/lead system may operate inappropriately or fail completely due to several potential complications.
Note the following potential complications.
• Pacing thresholds can change over time. Clinicians are advised to program a pacing threshold margin that will
prevent loss of capture in case of an increase in pacing threshold.
• Potential effects of premature battery depletion are decreased output voltage, no pacing output,
loss-of-capture, Recommended Replacement Time (RRT), Elective Replacement Indicator (ERI), and
eventual erratic pacing.
• Potential effects of pacemaker component(s) failure are loss of pacing output, pacing rate and other parameter
changes, reversion to asynchronous mode, loss-of-capture, loss of programming capability, Recommended
Replacement Time (RRT), Elective Replacement Indicator (ERI), and erratic pacing.
• Potential effects of the activity sensor detecting muscle or mechanical stimulation may increase the pacing
rate to levels higher than expected for a given patient activity. In addition, an open or shorted activity sensor
may cause rate response pacing to cease operating.
• Potential effects of electromagnetic interference (EMI) on the pacemaker’s circuitry are pacing output
inhibition, reversion to asynchronous mode, pacing synchronized to the EMI source, and a partial or full
electrical reset condition.
• Electromagnetic interference (EMI) from electrocautery and defibrillation may cause any of the following
conditions:
– pacing output inhibition
– temporary pause in pacing
– permanent loss of pacing output
– reversion to asynchronous mode
– pacing synchronized to the EMI source
– Recommended Replacement Time (RRT)
– Elective Replacement Indicator (ERI)
– partial or full electrical reset
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• Potential effects of poor connection of lead to pacemaker connector block are intermittent or continuous
loss-of-capture, failure to sense properly or loss of sensing, crosstalk between leads, and inhibition of pacing.
• Reversed connection of the atrial and ventricular leads will result in improper pacing and sensing operations.
• Potential effects of displaced or fractured lead are intermittent or continuous loss-of-capture and/or sensing,
and inhibition of pacing. Cardiac perforation may cause intermittent or continuous loss-of-capture and/or
sensing, inhibition of pacing, cardiac tamponade, and muscle or nerve stimulation. Myocardial irritability at the
time of lead insertion may cause fibrillation or flutter. Elevation of pacing thresholds may cause a
loss-of-capture.
9.2 Emergency pacing
Emergency pacing provides VVI pacing at high output settings in emergency situations for pacemaker-dependent
patients. Table 2 lists the emergency settings.
Table 2. Emergency settings
ParameterSetting
ModeVVI
Pacing Rate70 ppm
Ventricular
Amplitude7.5 V
Pulse Width1.5 ms
Sensitivity2.8 mV
Pacing PolarityUnipolar
Sensing PolarityUnipolar
Lead MonitorMonitor Only
Ventricular Refractory Period330 ms
Single Chamber HysteresisOff
Capture ManagementOff
10 Magnet operation and Elective Replacement Indicator (ERI)
Table 3. Magnet operation and Elective Replacement Indicator (ERI) status
Magnet operationIndicators of ERI status
Without magnetWith magnetWithout magnetWith magnet
DDDR/DDDDOO at 85 ppmVVI at 65 ppmVOO at 65 ppm
VDDVOO at 85 ppmVVI at 65 ppmVOO at 65 ppm
VVI/AAIVOO/AOO at 85 ppmVVI at 65 ppmVOO at 65 ppm
Note: For the purpose of determining Magnet Modes, the AAI<=>DDD and AAIR<=>DDDR modes are
considered dual chamber modes.
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Note: The device does not respond to the application of a magnet for one hour after the use of a programmer
unless the session is ended with the command option to immediately clear data collected in the device. The default
command for ending a session allows the device to retain collected data for one hour.
11 Device parameters
11.1 Shipping, nominal, and electrical reset parameters
Notes:
• “Unchanged” indicates that the programmed setting is unaffected by nominal programming or an electrical
reset event. “Adaptive” indicates that the parameter is adapted during operation.
• The shipping parameters for some features are not applied until the 30-minute Implant Detection period is
complete.
• After certain serious device errors, the pacemaker will recover as a Model SES01. If this occurs, contact a
Medtronic representative.
The MRI SureScan parameter cannot be programmed until the reset has been cleared.
Partial electrical
resetFull electrical reset
a
23
Off
a
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Table 15. Telemetry Features
ParameterShipping
Transtelephonic Moni-
OffUnchangedUnchangedOff
Medtronic
nominal
Partial electrical resetFull electrical reset
tor
Extended TelemetryOffUnchangedOffOff
Extended MarkerStandardUnchangedStandardStandard
11.2 Programmable parameters
Caution: Do not program device parameters before implant.
11.2.1 Pacing parameters
Caution: Do not program Rate Response until after Implant Detection is complete.
Caution: When programming Upper Tracking Rates of 190, 200, or 210 ppm, be careful to ensure that these rates
are appropriate for the patient. The Upper Tracking Rates of 190, 200, and 210 ppm are intended primarily for use
in pediatric patients.
Note: In the event of a component failure, the limits for atrial and ventricular rates are held independently to an
upper rate limit. This rate limit is automatically disabled with high rate temporary modes. If the Upper Tracking Rate
is set to 190 ppm or higher, the atrial and ventricular Rate Limit is 227 ppm. Otherwise, the atrial and ventricular
Rate Limit is 200 ppm.
Allocation (Collection Methodb = Frozen,
High Rate Type = AHR and VHR)
2 for 0/24; 2 for 24/0; 2 for 12/12; 4 for 0/12; 4 for 12/0; 4 for 6/6;
8 for 0/6; 8 for 6/0; 8 for 3/3 (number of episodes for pre-onset
seconds/post onset seconds collected)
Allocation (Collection Methodb = Frozen,
High Rate Type = AHR only or VHR only)
1 for 0/48; 1 for 48/0; 1 for 24/24; 2 for 0/24; 2 for 24/0; 2 for 12/12;
4 for 0/12; 4 for 12/0; 4 for 6/6; 8 for 0/6; 8 for 6/0; 8 for 3/3
(number of episodes for pre-onset seconds/post onset seconds
collected)
Allocation (Collection Methodb = Rolling,
High Rate Type = AHR and VHR)
2 for 16/0; 2 for 8/8; 2 for 0/24; 4 for 8/0; 4 for 4/4; 4 for 0/12; 8 for
4/0; 8 for 2/2; 8 for 0/6 (number of episodes for pre-onset seconds/post onset seconds collected)
Allocation (Collection Methodb = Rolling,
High Rate Type = AHR only or VHR only)
1 for 24/0; 1 for 12/12; 1 for 0/48; 2 for 16/0; 2 for 8/8; 2 for 0/24;
4 for 8/0; 4 for 4/4; 4 for 0/12; 8 for 4/0; 8 for 2/2; 8 for 0/6 (number
of episodes for pre-onset seconds/post onset seconds collected)
Grommets may protrude slightly beyond the can surface.
c
The radiopaque ID can be viewed in a fluoroscopic image of the device.
d
These materials have been successfully tested for the ability to avoid biological incompatibility. The device does
not produce an injurious temperature in the surrounding tissue during normal operation.
3
2
The Model ATDRL1 shield graphics are shown in Figure 6.
IS-1 marking in Figure 6 refers to the International Connector Standard (see Document No. ISO 5841-3) whereby
pulse generators and leads so designated are assured of meeting the electrical and mechanical parameters
specified in the IS-1 International Standard.
For more information about the A-V connectors, see Figure 2.
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Figure 6. Shield graphics: Model ATDRL1
µµ
1 A = atrial
3 IS-1 marking
2 V = ventricular
12.2 Electrical specifications
12.2.1 Output waveform
The output waveform for the pacemaker is shown in Figure 7.
Information about the battery used in the Attesta L DR MRI SureScan model ATDRL1 device is provided in the
following table.
1
Note: Usable capacity is defined from the Beginning of Service (BOS) to the End of Service (EOS).
Table 36.
Battery characteristics
ManufacturerMedtronic Energy and Component Center
ModelSigma 303
Number of battery cells1
1
Amplitude and pulse width measured per ISO 14708-2.
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Table 36. Battery characteristics (continued)
TypeSingle-cell lithium-iodine
Nominal voltage2.8 V
Usable capacity1.6 Ah
Residual capacity at RRT0.16 Ah
Table 37. Current consumption for Model ATDRL1
Current consumption (at 100% pacing)
Current consumption (at 100% inhibition)
a
Current consumption when pacing into 500 Ω ± 1% loads at the Beginning of Service in AAIR <=>DDDR or
a
b
22.12 µA
13.87 µA
AAI<=>DDD mode at 60 bpm, 2.5 V, 0.4 ms.
b
Current consumption when at the Beginning of Service in AAIR <=>DDDR or AAI<=>DDD mode at 60 bpm,
2.5 V, 0.4 ms.
12.2.3 Variation with temperature
Basic rate, test pulse rate, pulse duration, and pulse amplitude remain within expected tolerances when the device
temperature is between 20°C to 43°C (68°F to 109°F). Sensitivity at nominal conditions as measured at 37°C
(98.6°F) can vary up to ±1% per°C, from 22°C to 45°C (72°F to 113°F).
12.3 Projected service life
12.3.1 Projected service life for Model ATDRL1
Table 38. Model ATDRL1 Projected service life from implant to RRT, in years
A Amplitude,
Pacing
V Amplitude
DDDR or DDD, 0%1.5 V, 2.0 V
a
Rate,
Pulse Width
60 bpm, 0.4 ms15.915.9
2.5 V, 2.5 V14.814.8
3.5 V, 3.5 V15.515.5
DDDR or
DDD, 50%
1.5 V, 2.0 V
2.5 V, 2.5 V12.713.6
a
60 bpm, 0.4 ms14.114.9
3.5 V, 3.5 V11.212.9
AAIR<=>DDDR
or AAI<=>DDD
(MVP modes),
50% atrial,
1.5 V, 2.0 V
2.5 V, 2.5 V13.514.1
3.5 V, 3.5 V12.813.9
a
60 bpm, 0.4 ms14.915.4
5% ventricular
DDDR or
DDD, 100%
1.5 V, 2.0 V
2.5 V, 2.5 V11.112.6
a
60 bpm, 0.4 ms12.614.0
3.5 V, 3.5 V8.711.0
Lead impedance
500 Ω1000 Ω
Longevity (years)
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Table 38. Model ATDRL1 Projected service life from implant to RRT, in years (continued)
Lead impedance
500 Ω1000 Ω
Longevity (years)
Pacing
A Amplitude,
V Amplitude
Rate,
Pulse Width
DDDR or DDD, 0%2.5 V, 2.5 V70 bpm, 0.5 ms14.6—
5.0 V, 5.0 V14.3—
DDDR or
DDD, 100%
DDDR or
2.5 V, 2.5 V70 bpm, 0.5 ms9.7—
5.0 V, 5.0 V4.6—
5.0 V, 5.0 V70 bpm, 1.0 ms2.8—
DDD, 100%
DDDR or
5.0 V, 5.0 V100 bpm, 1.0 ms1.9—
DDD, 100%
a
For ACM, the Minimum Adapted Amplitude is 1.5 V (nominal). For VCM, the Minimum Adapted Amplitude is
2.0 V (nominal).
12.4 Prolonged service period
At most programmed settings, approximately 95% of pacemakers have a prolonged service period of at least 90
days between RRT and ERI, and 90 days between ERI and EOS.
The prolonged service period between RRT and EOS meet the following conditions, in conformance with ISO
14708-2:
• 100% pacing in DDD mode
• 60 bpm pacing rate
• 2.5 V atrial amplitude / 0.4 ms atrial pulse width
• 2.5 V ventricular amplitude / 0.4 ms ventricular pulse width
• 600 Ω pacing load
The mean prolonged service period is 241 days.
Note: After ERI, pacing parameters including mode and rate can be reprogrammed, however this may shorten the
ERI-to-EOS period.
12.4.1 Features disabled at RRT
The following features are disabled at RRT and cannot be programmed to On:
• MRI SureScan mode
• EP Studies
12.4.2 Features disabled at ERI
The following features are disabled at ERI and cannot be programmed to On:
• Single Chamber Hysteresis
• Sleep Function
• Ventricular Capture Management
• Atrial Sensing Assurance
• Ventricular Sensing Assurance
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12.5 Feature summary
This section describes the features available with the Attesta L DR MRI SureScan model ATDRL1 pacemaker.
Atrial Capture Management – This feature monitors the atrial pacing threshold with daily pacing threshold
searches and, if programmed to do so, adjusts the atrial pacing amplitude toward a target amplitude.
Atrial Preference Pacing (APP) – The system provides an overdrive pacing technique designed to counteract
potential atrial tachyarrhythmia initiating mechanisms. APP maintains a consistent activation sequence by
providing continuous pacing that is closely matched to the intrinsic rate.
Automatic Polarity Configuration – This feature uses Lead Monitor to automatically configure pacing and
sensing polarities for bipolar devices during Implant Detection.
Automatic PVARP – This feature protects against pacemaker-mediated tachycardia (PMT) and provides a higher
2:1 block rate, based on the mean atrial rate. Automatic PVARP enhances protection against PMT by lengthening
PVARP at lower tracking rates and provides a higher 2:1 block rate by shortening PVARP and SAV (if necessary)
at higher tracking rates.
Conducted AF Response – The feature regularizes the ventricular rhythm during AT/AF by modifying the pacing
rate on a beat-by-beat basis to achieve pacing of just over 50% of ventricular events.
Implant Detection – Implant Detection is a 30 min period, beginning when the device is placed in the surgical
pocket. During this period, the device verifies lead connection by measuring lead impedance. When the Implant
Detection period is completed, various automatic features and diagnostics are activated.
Lead Monitor – This feature measures lead impedances during the life of the implanted device and controls
automatic configuration of lead polarities at implant. If Lead Monitor is programmed to Adaptive, the device
automatically switches bipolar pacing and sensing to unipolar pacing and sensing if the integrity of a bipolar lead
is compromised.
Mode Switch – This feature switches the device from a tracking mode to a nontracking mode to prevent rapid
ventricular pacing that may result from a high atrial rate, and restores the programmed pacing mode when the atrial
tachyarrhythmia ends.
MRI SureScan – This feature allows patients with an implanted MRI SureScan system, including the device and
leads, to have a safe MRI procedure if the requirements provided in the MRI technical manual are followed.
MVP (Managed Ventricular Pacing) – MVP promotes intrinsic conduction by reducing unnecessary right
ventricular pacing. MVP operates when the programmed mode is either AAIR<=>DDDR or AAI<=>DDD.
Non-Competitive Atrial Pacing (NCAP) – This programmable feature is intended to prevent the triggering of
atrial tachycardias by delaying atrial paced events scheduled to occur during the atrial relative refractory period.
Pacing mode and rate programming after ERI – The pacing mode and rate parameters can be re-programmed
after the Elective Replacement Indicator (ERI) pacing mode and rate parameters have been set.
Pacemaker-Mediated Tachycardia (PMT) Intervention – This programmable feature provides automatic
detection and interruption of PMTs by extending the PVARP for one interval. This ensures that the next atrial event
in the PVARP will be refractory.
PMOP (Post Mode Switch Overdrive Pacing) – This atrial intervention feature works with the Mode Switch
feature to deliver overdrive atrial pacing during the vulnerable phase following an AT/AF episode termination.
PVC Response – This feature extends PVARP following a premature ventricular contraction (PVC) to avoid
tracking a retrograde P-wave and to prevent retrograde conduction from inhibiting an atrial pace.
Rate Adaptive AV (RAAV) – This feature varies the Paced AV (PAV) and Sensed AV (SAV) intervals as the heart
rate increases or decreases during dual chamber operation to maintain 1:1 tracking and AV synchrony.
Rate Drop Response – This programmable feature provides backup pacing for patients who experience
symptomatic episodes of a significant drop in heart rate. The device intervenes by elevating the pacing rate for a
brief period.
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Rate Profile Optimization – The goal of Rate Profile Optimization is to ensure that the rate response remains
appropriate for the full range of patient activities. This feature monitors the patient’s daily and monthly sensor rate
profiles and adjusts the rate response curves over time to achieve a prescribed target rate profile.
Rate-responsive pacing – This feature varies the pacing rate in response to the patient’s physical motion as
detected by the activity sensor of the device.
Search AV – This programmable feature searches for the patient’s intrinsic AV conduction time and adjusts the
Sensed AV (SAV) and the Paced AV (PAV) intervals to promote intrinsic activation of the ventricles and to track fast
atrial rates.
Sensing Assurance – This feature automatically monitors the peak amplitude of sensed signals and adjusts atrial
and ventricular sensitivities within defined limits to maintain adequate sensing margins. Sensing Assurance is
enabled at the completion of Implant Detection.
Sensor-varied PVARP – This programmable timing interval allows the device to automatically adjust the PVARP,
based on the sensor-indicated rate. This protects against pacemaker-mediated tachycardia (PMT) and provides
a higher 2:1 block rate.
Single Chamber Hysteresis – This feature enables tracking of the patient’s intrinsic rhythm below the
programmed Lower Rate to prevent pacing during extended periods of inactivity, such as when a patient is
sleeping.
Sinus Preference – This programmable feature is intended to improve cardiac hemodynamics by giving
preference to sinus activation of the heart over sensor-driven pacing. The device searches for and then tracks an
intrinsic sinus rate that is below the sensor-indicated rate in order to permit a slower intrinsic escape rate.
Sleep Function – This programmable feature suspends the programmed Lower Rate and replaces it with a Sleep
Rate during a specified sleep period.
Ventricular Capture Management – This feature provides automatic monitoring of ventricular pacing thresholds.
Ventricular Capture Management may be programmed to automatically adjust the ventricular Amplitude and Pulse
Width settings to maintain capture.
Ventricular Safety Pacing (VSP) – This feature prevents inappropriate inhibition of ventricular pacing caused by
crosstalk or ventricular oversensing.
Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
Bradycardia: +1 800 505 4636
Tachycardia: +1 800 723 4636