Medtronic W1DR01 Implant Manual

Azure™ XT DR MRI SureScan™ W1DR01

MR Conditional dual chamber pacemaker with SureScan™ technology and Bluetooth
wireless telemetry (OAE-DDDR)

®

Device Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The following list includes trademarks or registered trademarks of Medtronic in the United States and
possibly in other countries. All other trademarks are the property of their respective owners.

Advisa, Advisa DR MRI, Azure, Capture Management, Cardiac Compass, CareAlert, CareLink, EnPulse,
EnRhythm, EnRhythm MRI, Flashback, GEM, GEM III, Integrity, Kappa, Marquis, Medtronic,
Medtronic AT500, Medtronic CareAlert, Medtronic CareLink, MVP, Quick Look, Reactive ATP, Revo MRI,
SureScan, TherapyGuide

Contents

1 System overview 4

1.1 Introduction 4

1.2 System description 4

1.3 Indications and usage 5

1.4 Contraindications 6

1.5 MRI conditions for use 6

1.6 Feature summary 7

1.7 Data security 9

2 Warnings, precautions, and potential adverse events 9

2.1 General warnings and precautions 9

2.2 Explant and disposal 9

2.3 Handling and storage instructions 10

2.4 Lead evaluation and lead connection 10

2.5 Device operation 11

2.6 Potential adverse events 12

3 Clinical data 13

3.1 Adverse events and clinical trial data 13

4 Implant procedure 14

4.1 Preparing for an implant 14

4.2 Selecting and implanting the leads 16

4.3 Testing the lead system 17

4.4 Connecting the leads to the device 17

4.5 Positioning and securing the device 19

4.6 Completing the implant procedure 19

4.7 Replacing a device 20

5 Product specifications 21

5.1 Physical characteristics 21

5.2 Electrical specifications 22

5.3 Replacement indicators 23

5.4 Projected service life 24

6 Device parameters 26

6.1 Emergency settings 26

6.2 Magnet application 26

6.3 Tachyarrhythmia detection parameters 27

6.4 Atrial tachyarrhythmia therapy parameters 27

6.5 Pacing parameters 29

6.6 Data collection parameters 34

6.7 Medtronic CareAlert parameters 34

6.8 System test parameters 35

6.9 EP Study parameters 36

6.10 Nonprogrammable parameters 39

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1 System overview

1.1 Introduction

This manual describes the Medtronic Model W1DR01 Azure XT DR MRI SureScan dual chamber, implantable
pulse generator (IPG). It contains model-specific feature information, indications and contraindications, warnings
and precautions, instructions for implanting the device, quick reference specifications, and parameter tables.

The following manuals and documents also contain information about the device:

MRI technical manual – This manual provides MRI-specific procedures and warnings and precautions.

Reference manual – This manual contains information about device features. The reference manual applies to

multiple models of IPG devices.

Programming guide – This manual explains how to use the programmer software to conduct a patient session.

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.

Radio regulatory compliance information – This document provides compliance information related to the
radio components of the device.

1.2 System description

The Medtronic Azure XT DR MRI SureScan Model W1DR01 dual chamber implantable pulse generator (IPG) is
a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual
chamber rate-responsive bradycardia pacing and atrial tachyarrhythmia therapies. This device features Bluetooth
wireless technology.

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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.

Rate response – Rate response is controlled through an activity-based sensor.

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.

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.

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The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by
Medtronic is under license.

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●

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 Section 1.5, “MRI conditions for use”,
page 6.

●

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.

1.2.2 System components and accessories

Contents of sterile package – The package contains 1 implantable pulse generator (IPG) and 1 torque wrench.

Implantable device system – The Azure XT DR MRI SureScan Model W1DR01 device and the pacing leads

constitute the implantable portions of the device system.

Leads – The lead system used with this device must provide sensing and pacing to the right ventricle (RV) and to
the atrium (A). Do not use any lead with this device without first verifying lead and connector compatibility.

For information about selecting and implanting SureScan leads for this device, refer to Section 4.2, “Selecting and
implanting the leads”, page 16.

Programmers and software – Medtronic programmers and software are used to program this device.
Programmers from other manufacturers are not compatible with Medtronic devices, but they do not damage
Medtronic devices.

Medtronic pacing system analyzer – A pacing system analyzer is used to measure the electrical characteristics
of the implanted leads to assess their effectiveness for pacing and sensing.

Medtronic patient monitor – Patients use the Medtronic patient monitor, if available, to gather information from
their implanted devices and communicate the information to their physicians through the Medtronic CareLink
Network. For information on using the patient monitor, refer to the patient monitor literature.

1.3 Indications and usage

The Azure XT DR MRI SureScan Model W1DR01 system is indicated for the following conditions:

●

Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in
activity

●

Accepted patient conditions warranting chronic cardiac pacing, which 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 Azure XT DR MRI SureScan Model W1DR01 device is also indicated for dual chamber and atrial tracking
modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically
indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which
include:

●

Various degrees of AV block to maintain the atrial contribution to cardiac output

●

VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm

●

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.

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1.4 Contraindications

The Azure XT DR MRI SureScan Model W1DR01 system is contraindicated for:

●

Concomitant implant with another bradycardia device

●

Concomitant implant 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.

1.5 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.

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.

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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.

1.6 Feature summary

The following features are available in this device. For a list of the features that are enabled at shipping, see the
“Shipped” column of the tables in Chapter 6, “Device parameters”, page 26.

1.6.1 Tachyarrhythmia detection and therapy features

Atrial antitachycardia pacing (ATP) – These therapies respond to an AT/AF episode or a Fast AT/AF episode

with rapid sequences of pacing pulses to terminate detected atrial tachyarrhythmias.

Reactive ATP – This feature allows the device to deliver atrial ATP therapies that had been unsuccessful earlier
in an AT/AF episode. The device repeats the delivery of atrial ATP therapies after the programmed time interval or
when the atrial rhythm changes.

1.6.2 Pacing features

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 intervention pacing features – The system provides the following overdrive pacing techniques that are
designed to counteract potential atrial tachyarrhythmia initiating mechanisms:

●

Atrial Preference Pacing (APP) maintains a consistent activation sequence by providing continuous pacing
that is slightly higher than the intrinsic rate.

●

Atrial Rate Stabilization (ARS) adapts the atrial pacing rate in response to a PAC (premature atrial
contraction) to avoid long sinus pauses following short atrial intervals.

●

Post Mode Switch Overdrive Pacing (PMOP) works with the Mode Switch feature to deliver overdrive atrial
pacing during the vulnerable phase following an AT/AF episode termination.

Automatic polarity configuration – This device uses lead impedance measurements to automatically configure
pacing and sensing polarities during Implant Detection.

Automatic PVARP – This feature adjusts PVARP (Post-Ventricular Atrial Refractory Period) in response to
changes in the patient’s heart rate or pacing rate. PVARP is longer at lower tracking rates to prevent
pacemaker-mediated tachycardia (PMT) and shorter at higher rates to maintain 1:1 tracking.

Conducted AF Response – This feature regularizes the ventricular rhythm during conducted AT/AF by modifying
the pacing rate on a beat-by-beat basis to closely match the patient’s average ventricular response.

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) – The MVP feature promotes intrinsic conduction by reducing unnecessary
right ventricular pacing. This feature operates when the programmed mode is either AAIR<=>DDDR or
AAI<=>DDD.

Non-Competitive Atrial Pacing (NCAP) – This feature prevents pacing the atrium too soon after a refractory
atrial sense by delaying the scheduled atrial pace.

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Pacemaker-mediated Tachycardia (PMT) Intervention – This feature provides automatic detection and
interruption of device-defined PMTs.

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 feature monitors the heart for a significant drop in rate and responds by pacing the
heart at an elevated rate for a programmed duration.

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.

RV Capture Management – This feature monitors the right ventricular pacing threshold with daily pacing
threshold searches and, if programmed to do so, adjusts the RV pacing amplitude toward a target amplitude.

Sleep feature – This feature causes the device to pace at a slower rate during a programmed sleep period.

Ventricular Rate Stabilization (VRS) – This feature adjusts the pacing rate dynamically to eliminate the long

pause that typically follows a premature ventricular contraction (PVC).

Ventricular Safety Pacing (VSP) – This feature prevents inappropriate inhibition of ventricular pacing caused by
crosstalk or ventricular oversensing.

1.6.3 Monitoring and follow-up features

Cardiac Compass Trends – This feature provides a Cardiac Compass Trends report that shows an overview of

the patient’s condition, with graphs that display long-term trends in heart rhythm over the last 14 months.

Medtronic CareAlert Monitoring – If the device identifies any programmed or automatic CareAlert conditions,
this feature sends a wireless alert signal to the patient monitor (if available). The patient monitor then transmits the
CareAlert Event data to the Medtronic CareLink Network. If configured to do so, the Medtronic CareLink Network
then sends an alert notification to the clinic.

Episode data and EGM storage – The system provides an arrhythmia episode log that enables you to view the
summary and detailed diagnostic data quickly, including stored EGM, for the selected arrhythmia episode.

Flashback memory – This diagnostic feature records intervals that occur immediately prior to tachyarrhythmia
episodes or the most recent interrogation and plots the interval data over time.

Holter telemetry – This function allows the implanted device to transmit an EGM with marker telemetry
continuously for up to 46 hours, regardless of the use of the programming head.

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.

MVP Mode Switches – This feature lists the 10 most recent MVP Mode Switches to DDD(R).

Rate Drop Response episodes data – This feature displays beat-to-beat data that is useful in analyzing Rate

Drop Response episodes and the events leading up to these episodes. The feature records data about episodes
that meet the programmed rate drop detection criteria.

Rate Histograms report – This report shows heart rate range distributions for the patient.

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TherapyGuide – This feature provides a set of suggested parameters based on the programmed information
about the patient’s clinical conditions. The TherapyGuide feature does not replace a physician’s expert judgment.
The physician is free to accept, reject, or modify any of the suggested parameter values.

1.7 Data security

Medtronic has designed safeguards to protect patient information and device data for the
Azure XT DR MRI SureScan Model W1DR01 device.

Bluetooth communication system – The device shows its availability through Bluetooth communication.
Critical data accepted or sent through the Bluetooth communication from the device is encrypted by the device
before it is sent over the Bluetooth channel. The device responds only to authorized commands.

Inductive telemetry communication system – The Medtronic inductive telemetry communication system is
used with the clinician programmer to interrogate and program the device. It can also be used to interrogate the
device for remote monitoring, if available. This system uses short-range communication that protects patient
information and device data.

2 Warnings, precautions, and potential adverse events

2.1 General warnings and precautions

Before performing an MRI scan, refer to the Medtronic MRI technical manual for MRI-specific warnings
and precautions.

Refer to the Medical Procedure and EMI Warnings and Precautions Manual for information about hazards related
to medical therapies and diagnostic procedures on patients with cardiac devices. This manual also includes
information about sources of EMI in the patient’s environment.

Anti-coagulation – Use of the device should not change the application of established anti-coagulation protocols.

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.

External defibrillation equipment – Keep external defibrillation equipment nearby for immediate use whenever
tachyarrhythmias are possible or intentionally induced during device testing, implant procedures, or post-implant
testing.

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.

A complete SureScan pacing system includes a SureScan device connected to SureScan leads. Before

performing an MRI scan, refer to the Medtronic MRI technical manual for additional information.

2.2 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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2.3 Handling and storage instructions

Carefully observe these guidelines when handling or storing the device.

2.3.1 Device handling

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 an inner tray. Do not use the
device or accessories if the outer or inner 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 Medtronic 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
Medtronic to request a replacement manual.

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.

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.

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.

Fluid immersion – Do not immerse the device in fluid or flush the connector ports at the time of implant. Doing so
could adversely affect the performance of the device and lead system.

“Use by” date – Do not implant the device after the “Use by” date because the battery longevity could be reduced.

For single use only – Do not resterilize and reimplant an explanted device.

2.3.2 Device storage

Avoid magnets – To avoid damaging the device, store the device in a clean area away from magnets, kits

containing magnets, and any sources of electromagnetic interference.

Temperature limits – 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).

2.4 Lead evaluation and lead connection

Refer to the lead technical manuals for specific instructions and precautions about lead handling.

A Medtronic MRI SureScan system includes a Medtronic MRI SureScan device connected to Medtronic MRI
SureScan leads. Before performing an MRI procedure, refer to the Medtronic MRI technical manual for

additional information.

Torque wrench – Use only the torque wrench supplied with the device. The torque wrench is designed to prevent

damage to the device from overtightening a setscrew. Other torque wrenches (for example, a blue-handled or
right-angled hex wrench) have torque capabilities greater than the lead connector can tolerate.

Lead connection – Consider the following information when connecting the lead 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.

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2.5 Device operation

Leads – Bipolar or unipolar leads may be used with the Azure XT DR MRI SureScan Model W1DR01 device, but

if leads other than bipolar MRI SureScan leads are used, the system is contraindicated for MRI scans.

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.

Maximum output for the Atrial Capture Management feature – The Atrial Capture Management feature does
not adjust atrial outputs to values greater than 5.0 V or 1.0 ms. If the patient needs atrial pacing output greater than

5.0 V or 1.0 ms, manually program the atrial amplitude and pulse width. If a lead dislodges partially or completely,
the Atrial Capture Management feature may not prevent loss of capture.

Atrial lead maturation – Do not program AT/AF detection to On or enable automatic atrial ATP therapies until the
atrial lead has matured (approximately 1 month after implant). If the atrial lead dislodges and migrates to the
ventricle, the device could inappropriately detect AT/AF, deliver atrial ATP to the ventricle, and possibly induce a
life-threatening ventricular tachyarrhythmia.

Device status indicators – If any of the device status indicators (for example, Device 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.

Device reset – Temperatures below –18°C (0°F) or strong electromagnetic fields can reset the device. 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 bpm. Device 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. Inform a Medtronic representative if your patient’s
device has reset.

End of Service (EOS) indicator – Replace the device immediately if the programmer displays an EOS indicator.
The device may soon lose the ability to pace, sense, and deliver therapy adequately.

Extended Upper Tracking Rate – When programming Upper Tracking Rates of 190, 200, or 210 bpm, be careful
to ensure that these rates are appropriate for the patient.

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.

Magnets – Placing a magnet over the device suspends tachyarrhythmia detection and initiates asynchronous,
fixed-rate bradycardia pacing. The programming head contains a magnet that can cause magnet operation to
occur. However, magnet operation does not occur if telemetry between the device and the programmer is
established or if the MRI SureScan mode is programmed to On.

Pace polarity – Pace polarity must be bipolar to program the MRI SureScan mode to On.

PMT (pacemaker-mediated tachycardia) Intervention – Even with the PMT Intervention feature programmed

to On, PMTs may still require clinical intervention, such as device reprogramming, drug therapy, or lead evaluation.

Pacing and sensing safety margins – Lead maturation (at least one month after implant) may cause sensing
amplitudes to decrease and pacing thresholds to increase, which can cause undersensing or a loss of capture.
Provide an adequate safety margin when selecting values for pacing amplitude, pacing pulse width, and sensitivity
parameters.

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Programmers – Use only Medtronic programmers and application software to communicate with the device.
Programmers and software from other manufacturers are not compatible with Medtronic devices.

Rate control – Decisions regarding rate control should not be based on the ability of the device to prevent atrial
arrhythmias.

Rate-responsive modes – Do not program rate-responsive modes for patients who cannot tolerate rates above
the programmed Lower Rate. Rate-responsive modes may cause discomfort for those patients.

Right ventricular apical pacing – Right ventricular apical pacing may be associated with an increased risk of
atrial fibrillation, left ventricular dysfunction, and congestive heart failure.

Maximum output for the RV Capture Management feature – The RV Capture Management feature does not
program right ventricular outputs to values greater than 5.0 V or 1.0 ms. If the patient needs right ventricular pacing
output greater than 5.0 V or 1.0 ms, manually program right ventricular amplitude and pulse width. If a lead
dislodges partially or completely, the RV Capture Management feature may not prevent loss of capture.

Sensitivity setting – Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before
changing the sensitivity from its nominal setting to a more sensitive setting.

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 and PMT – Slow retrograde conduction may induce pacemaker-mediated
tachycardia (PMT) when the VA conduction time is greater than 400 ms. Programming PMT Intervention can help
prevent PMT only when the VA conduction time is less than 400 ms.

Testing for cross-stimulation – At implant, and regularly when atrial ATP therapy is enabled, conduct testing at
the programmed atrial ATP output settings to ensure that ventricular capture does not occur. Testing for
cross-stimulation is particularly important when the lead is placed in the inferior atrium.

2.5.1 Pacemaker-dependent patients

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 in the ventricle.

ODO pacing mode – Pacing is disabled under the ODO pacing mode. Do not program the ODO mode for
pacemaker-dependent patients. Instead, use the Underlying Rhythm Test to provide a brief period without pacing
support.

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.

Underlying Rhythm Test – Use caution when using the Underlying Rhythm Test to inhibit pacing. The patient is
without pacing support when pacing is inhibited.

2.6 Potential adverse events

The following are known potential adverse events 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

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●

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

3 Clinical data

3.1 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
Azure XT DR MRI SureScan Model W1DR01 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 Azure XT DR MRI SureScan Model

13

W1DR01 devices. Note that the Ventricular Response Pacing (VRP) feature mentioned in the study is called
Conducted AF Response in Azure XT DR MRI SureScan Model W1DR01 devices

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.

Atrial Therapy Efficacy and Safety Trial (ATTEST) – This clinical study, which evaluated the safety and efficacy
of the Medtronic AT500 DDDRP Pacing System devices, provides support for the Azure XT DR MRI SureScan
Model W1DR01 devices.

EnRhythm clinical study – This clinical study, which evaluated the safety and efficacy of the EnRhythm Model
P1501DR devices, provides support for MVP mode pacing and the Reactive ATP feature in the
Azure XT DR MRI SureScan Model W1DR01 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 Azure XT DR MRI SureScan Model
W1DR01 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 Azure XT DR MRI SureScan Model
W1DR01 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.

4 Implant procedure

4.1 Preparing for an implant

The following implant procedures are provided for reference only. Proper surgical procedures and sterile
techniques are the responsibility of the physician. Each physician must apply the information in these procedures
according to professional medical training and experience.

For information about replacing a previously implanted device, see Section 4.7, “Replacing a device”, page 20.

Ensure that you have all of the necessary instruments, system components, and sterile accessories to perform the
implant.

14

Connect the skin electrodes to the patient if you would like to display surface ECG signals on the programmer. See
the programmer reference manual for more information.

4.1.1 Instruments, components, and accessories required for an implant

The following non-implanted instruments are used to support the implant procedure:

●

Medtronic programmer with a programming head

●

programmer software application for the Azure XT DR MRI SureScan Model W1DR01 device

●

Model 2290 Analyzer or equivalent pacing system analyzer

●

external defibrillator

The following sterile system components and accessories are used to perform the implant:

●

implantable device and lead system components

●

programming head sleeve
Note: If a sterilized programming head is used during an implant, a sterile programming head sleeve is not
necessary.

●

pacing system analyzer cables

●

lead introducers appropriate for the lead system

●

extra stylets of appropriate length and shape

4.1.2 Setting up the programmer and starting the application

See the programmer reference manual for instructions about how to set up the programmer. The software
application for the Azure XT DR MRI SureScan Model W1DR01 device should be installed on the programmer.
Your Medtronic representative can install this software, if necessary. Establish telemetry with the device and start
a patient session.

4.1.3 Considerations for preparing for an implant

Review the following information before implanting the leads or device:

Before performing an MRI scan, refer to the Medtronic MRI Technical Manual for additional information.

Warning: Bipolar or unipolar leads may be used with the Azure XT DR MRI SureScan Model W1DR01 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: 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.

Warning: Keep external defibrillation equipment nearby for immediate use. Potentially harmful spontaneous or
induced tachyarrhythmias may occur during device testing, implant procedures, and post-implant testing.

Caution: The device is intended for implant in the pectoral region with Medtronic transvenous leads. No claims of
safety and efficacy can be made with regard to other acutely or chronically implanted lead systems that are not
manufactured by Medtronic.

Caution: Unipolar atrial leads may be used with the device, but bipolar atrial leads are recommended. If unipolar
atrial leads are used, AT/AF Detection must be programmed to Monitor and the Capture Management feature must
be programmed to Off.

Caution: Do not implant the device after the “Use by” date on the package label. Battery longevity could be
reduced.

15

To retain the ability to safely scan the SureScan pacing system during MRI scans, the MRI conditions for use in
Section 1.5, “MRI conditions for use”, page 6 must be followed. Refer to the MRI technical manual for additional
information.

4.1.4 How to prepare the device for implant

Before opening the sterile package, perform the following steps to prepare the device for implant:

1. Interrogate the device and print an Initial Interrogation Report.
Caution: If the programmer reports that a device reset occurred, do not implant the device. Contact a
Medtronic representative.

2. Check the Initial Interrogation Report to confirm that the battery voltage is at least 2.85 V at room temperature.
If the device has been exposed to low temperatures, then the battery voltage will be temporarily lower. Allow
the device to warm to room temperature for at least 48 hours and check the battery voltage again. If an
acceptable battery voltage cannot be obtained, contact a Medtronic representative.
Note: The device automatically measures the battery voltage several times a day. The battery voltage
reported on the Battery and Lead Measurements screen is an average of recent automatic measurement
values.

3. Select Params > Data Collection Setup > Device Date/Time… to select the Time Zone for the internal clock
of the device.

4. Program the therapy and pacing parameters to values appropriate for the patient. Ensure that
tachyarrhythmia detection is not programmed to On.
Note: Do not enable a pacing feature that affects the pacing rate (for example, Ventricular Rate Stabilization)
before implanting the device. Doing so may result in a pacing rate that is faster than expected.

4.2 Selecting and implanting the leads

Use the guidelines in this section to select leads that are compatible with the device. The appropriate techniques
for implanting the leads may vary according to physician preference and the patient’s anatomy or physical
condition. Consult the technical manuals supplied with the leads for specific implant instructions.

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.

4.2.1 Selecting the leads

The device is typically implanted with the following leads:

●

1 bipolar transvenous lead in the right ventricle (RV) for sensing and pacing

●

1 bipolar transvenous lead in the atrium (A) for sensing and pacing. Use of a bipolar atrial lead with ring and
tip electrodes spaced ≤ 10 mm apart to reduce far-field R-wave sensing is recommended.

4.2.2 How to verify lead and connector compatibility

Warning: Verify lead and connector compatibility before using a lead with this device. Using an incompatible lead

may damage the connector, resulting in electrical current leakage or resulting in an intermittent electrical
connection.

Note: Medtronic 3.2 mm low-profile leads are not directly compatible with the device IS-1 connector block.

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.

Use the information in Table 1 to select a compatible lead.

16

Table 1. Lead and connector compatibility

Connector port Primary leads

A, V IS-1a bipolar and IS-1 unipolar

a

IS-1 refers to the international standard ISO 5841-3.

4.2.3 Implanting the leads

Implant the leads according to the instructions in the technical manuals supplied with the leads unless suitable
chronic leads are already in place.

Warning: Pinching the lead can damage the lead conductor or insulation, which may result in the loss of sensing
or pacing therapy.

Transvenous leads – If you use a subclavian approach to implant a transvenous lead, position the lead laterally
to avoid pinching the lead body between the clavicle and the first rib.

4.3 Testing the lead system

After the leads are implanted, test the lead system to verify that the sensing and pacing values are acceptable.
Refer to the literature provided with the pacing system analyzer for instructions.

Note: Do not measure the intracardiac EGM that is telemetered from the device to assess sensing.

Note: The measured pacing lead impedance is a reflection of measuring equipment and lead technology. Refer

to the lead technical manual for acceptable impedance values.

Bipolar leads – When measuring sensing and pacing values, measure between the tip (cathode) and ring
(anode) of each bipolar pacing/sensing lead.

Unipolar leads – When measuring sensing and pacing values, measure between the tip (cathode) of each
unipolar pacing/sensing lead and an indifferent electrode (anode) used in place of the device can.

Table 2. Acceptable sensing and pacing values

Measurements required Acute transvenous leads Chronic leads

a

P-wave EGM amplitude (atrial) ≥ 2 mV ≥ 1 mV

R-wave EGM amplitude (RV) ≥ 5 mV ≥ 3 mV

Slew rate

≥ 0.5 V/s (atrial) ≥ 0.3 V/s (atrial)

≥ 0.75 V/s (RV) ≥ 0.5 V/s (RV)

Capture threshold (0.5 ms pulse width)

≤ 1.5 V (atrial) ≤ 3.0 V (atrial)

≤ 1.0 V (RV) ≤ 3.0 V (RV)

a

Chronic leads are leads implanted for 30 days or more.

4.4 Connecting the leads to the device

The following procedure describes how to connect the lead to the device, how to confirm that the lead connector
is fully inserted in the connector block, and how to verify that the lead connection is secure.

17

Warning: After connecting the leads, verify that the lead connections are secure by gently tugging on each lead.

1a

1b

A loose lead connection may result in inappropriate sensing, which can cause false tracking and false inhibition of
pacing, or inappropriate atrial tachyarrhythmia therapy.

Caution: Use only the torque wrench supplied with the device. The torque wrench is designed to prevent damage
to the device from overtightening a setscrew.

4.4.1 How to connect a lead to the device

1. Insert the torque wrench into the appropriate setscrew.

a. If the setscrew obstructs the port, retract the setscrew by turning it counterclockwise until the port is clear.

Take care not to disengage the setscrew from the connector block (see Figure 1).

b. Leave the torque wrench in the setscrew until the lead connection is secure. This action allows a pathway

for venting trapped air when the lead connector is inserted into the connector port.

Figure 1. Inserting the torque wrench into the setscrew

2. Push the lead connector into the connector port until the lead connector pin is clearly visible in the pin viewing
area. No sealant is required.

3. Confirm that the lead is fully inserted into the connector pin cavity by viewing the device connector block from
the side or end.

a. The lead connector pin should be clearly visible beyond the setscrew block (see Figure 2).
b. The lead connector ring should be completely inside the spring contact block. There is no setscrew in this

location (see Figure 2).

18

Figure 2. Confirming the lead connection

3b

3a

4. Tighten the setscrew by rotating it clockwise until the torque wrench clicks. Remove the torque wrench.

5. Gently tug on the lead to confirm a secure fit. Do not pull on the lead until the setscrew has been tightened.

6. Repeat these steps for each lead.

4.5 Positioning and securing the device

Caution: Program AT/AF detection to Monitor to avoid inappropriate therapy delivery while closing the pocket.

Note: Implant the device within 4 cm (1.6 in) of the surface of the skin to optimize post-implant ambulatory

monitoring.

4.5.1 How to position and secure the device

1. Verify that each lead connector pin 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 (see Figure 3).
Do not kink the lead body.

Figure 3. Rotating the device to wrap the leads

3. Place the device and the leads into the surgical pocket.

4. Use nonabsorbable sutures to secure the device within the pocket and minimize post-implant rotation and
migration. Use a surgical needle to penetrate the suture hole on the device.

5. Suture the pocket incision closed.

4.6 Completing the implant procedure

Warning: Do not program AT/AF detection to On or enable automatic atrial ATP therapies until the atrial lead has

matured (approximately 1 month after implant). If the atrial lead dislodges and migrates to the ventricle, the device
could inappropriately detect AT/AF, deliver atrial ATP to the ventricle, and possibly induce a life-threatening
ventricular tachyarrhythmia.

19

4.6.1 How to complete programming the device

1. If unipolar leads are implanted, you may want to manually complete the Implant Detection process.

a. Select the Params icon.
b. Program the Pace Polarity and Sense Polarity parameters to Unipolar.
c. Select Additional Features… and program the Implant Detection parameter to Off/Complete.

2. Verify that the pacing, detection, and atrial ATP therapies parameters are programmed to values that are
appropriate for the patient.

3. Enter the patient’s information.
Note: Be sure to use the Patient Information screen to enter complete information about the implanted leads.
Be sure to use the MRI SureScan System/Other Hardware screen to enter complete information about other
hardware implanted in the patient, including abandoned devices or leads, and 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.

4. Program the Medtronic CareAlert parameters, if applicable.

5. Program the Data Collection Setup parameters.

4.6.2 How to assess the performance of the device and the leads

After implanting the device, x-ray the patient as soon as possible to verify device and lead placement. Before the
patient is discharged from the hospital, assess the performance of the implanted device and leads.

1. Monitor the patient’s electrocardiogram until the patient is discharged. If a lead dislodges, it usually occurs
during the immediate postoperative period.

2. Check the pacing and sensing values, and adjust the values if necessary. Verify the safety margin for the
pacing threshold.

3. Interrogate the device, and print a Final Report to document the postoperative programmed device status.

4.7 Replacing a device

To retain the ability to safely scan the SureScan pacing system during MRI scans, the MRI conditions for use in
Section 1.5, “MRI conditions for use”, page 6 must be followed. Refer to the Medtronic MRI technical manual for
additional information.

Warning: Bipolar or unipolar leads may be used with the Azure XT DR MRI SureScan Model W1DR01 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 external pacing equipment nearby for immediate use. The patient does not receive pacing therapy
from the device when the lead is disconnected, or when the device is removed from the pocket while the device
is operating in unipolar pacing mode.

Caution: Disable tachyarrhythmia detection to avoid inappropriate therapy delivery while explanting the device.

Caution: Unipolar atrial leads may be used with the device, but bipolar atrial leads are recommended. If unipolar

atrial leads are used, AT/AF Detection must be programmed to Monitor and the Capture Management feature must
be programmed to Off.

Note: To meet the implant requirements, you may need to reposition or replace the chronic leads. For more
information, see Section 4.2, “Selecting and implanting the leads”, page 16.

20

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.

4.7.1 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 block.

4. Gently pull the leads out of the connector ports.

5. Evaluate the condition of each lead (see Section 4.3, “Testing the lead system”, page 17). Replace a lead if
the electrical integrity is not acceptable or if the lead connector pin is pitted or corroded. If you explant the lead,
return the lead to Medtronic for analysis and disposal.

6. Connect the leads to the replacement device (see Section 4.4, “Connecting the leads to the device”,
page 17).
Note: Lead adaptors may be needed to connect the leads to the replacement device. Contact a Medtronic
representative for information 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. Position and secure the device in the surgical pocket, and suture the pocket incision closed (see Section 4.5,
“Positioning and securing the device”, page 19).

8. 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.

5 Product specifications

5.1 Physical characteristics

Table 3. Physical characteristics

Volume

a

12.75 cm

Mass 22.5 g

H x W x D

Radiopaque ID

b

c

46.6 mm x 50.8 mm x 7.4 mm

RNA

Medtronic identifier

Surface area of titanium device can 33.48 cm

Materials in contact with human tissue

d

Titanium, polyurethane, silicone rubber

Battery Lithium-hybrid CFx silver vanadium oxide

a

Volume with connector holes unplugged.

b

Grommets may protrude slightly beyond the can surface.

c

The radiopaque ID, which includes a Medtronic-identifier symbol, 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

21

Figure 4. Connector and suture hole

1 IS-1 connector port, A
2 IS-1 connector port, V

The Model W1DR01 shield graphics are shown in Figure 5.

The IS-1 marking in Figure 5 indicates that the lead connectors conform to ISO 5841-3.

Figure 5. Shield graphics: Model W1DR01

1 A = atrial
2 V = ventricular

3 Suture hole

3 IS-1 marking

5.2 Electrical specifications

Table 4. Battery characteristics

Manufacturer Medtronic Energy and Component Center

Model Delta 26H3

Number of battery cells 1

Chemistry Lithium-hybrid CFx silver vanadium oxide

22

Table 4. Battery characteristics (continued)

Nominal voltage 3.25 V

Mean usable capacity 1.2 Ah

Mean capacity to RRT 0.97 Ah

Residual usable capacity at RRT 0.23 Ah

Table 5. Current consumption

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 DDDR mode at 60 bpm,

a

b

10.40 µA

6.71 µA

2.5 V, 0.4 ms.

b

Current consumption when at the Beginning of Service in DDDR mode at 60 bpm, 2.5 V, 0.4 ms, 500 Ω ± 1%.

Figure 6. Output waveform at nominal conditions (resistive load: 500 Ω)

5.2.1 Variation with temperature

Basic rate, test pulse rate, pulse duration, and pulse amplitude remain within expected tolerances when the device
temperature is between 22°C and 45°C (72°F to 113°F). Sensitivity at nominal conditions as measured at 37°C
(98.6°F) can vary as much as ±1% per °C from 22°C to 45°C (72°F to 113°F).

5.3 Replacement indicators

The battery voltage and messages about replacement status appear on the programmer display and on printed
reports. The Recommended Replacement Time (RRT), Elective Replacement Indicator (ERI), and the End of
Service (EOS) conditions are listed in Table 6.

Table 6. Replacement indicators

Recommended Replacement Time (RRT) ≤ 2.63 V on 3 consecutive daily automatic measure-

ments

Elective Replacement Indicator (ERI) 3 months after RRT

End of Service (EOS) 3 months after ERI

RRT date – The programmer displays the date when the battery reached RRT on the Quick Look II and Battery and
Lead Measurements screens.

23

Replace at EOS – If the programmer indicates that the device is at EOS, replace the device immediately.

RRT operation – When the device reaches RRT, it continues to operate with its programmed parameters.

However, placing a magnet over the device initiates asynchronous pacing at 65 bpm rather than at 85 bpm.

ERI operation – When the device reaches ERI, it automatically changes the value of several parameters as shown
in Table 7.

Table 7. Parameter settings after ERI

Pacing Mode VVI

Lower Rate 65 bpm

RV Amplitude as programmed

RV Pulse Width as programmed

Rate Hysteresis Off

Sleep Off

V. Rate Stabilization Off

AT/AF Detection Monitor

Pre-arrhythmia EGM Off

a

When AT/AF Detection is set to Monitor, AT/AF therapies are not available.

b

Pre-arrhythmia EGM cannot be reprogrammed after ERI.

a

b

Note: After ERI, all pacing parameters can be programmed, including mode and rate. Reprogramming the pacing
parameters may reduce the duration of the ERI to EOS period.

Note: When the MRI SureScan mode is programmed to On, battery measurements are taken, but the device does
not report RRT, EOS, or ERI until the MRI SureScan mode has been programmed to Off.

Prolonged Service Period – The Prolonged Service Period (PSP) is the time between the RRT and EOS. The
PSP is defined as 6 months assuming the following conditions: 100% DDD pacing at 60 bpm, 2.5 V atrial and RV
pacing amplitude; 0.4 ms pulse width; and 600 Ω pacing load. The EOS may be indicated before the end of 6
months if the device exceeds these conditions.

5.4 Projected service life

The projected service life in years for the device is shown in Table 8. The data is based on pacing outputs
programmed to the specified amplitude and 0.4 ms pulse width and 60 bpm pacing rate.

The service life of the device is affected by the programmed settings for certain features, such as Pre-arrhythmia
EGM storage.

Projected service life estimates are based on accelerated battery discharge data and device modeling as
specified. These values should not be interpreted as precise numbers.

Delivery of atrial antitachycardia pacing therapy does not appreciably alter the longevity, considered with the
inhibition of atrial pacing during the AT/AF episode.

24

Table 8. Projected service life in years

Pacing

Pre-arrhythmia
EGM storage

a

500 Ω pacing
impedance

2.5 V 3.5 V 2.5 V 3.5 V 2.5 V 3.5 V

600 Ω pacing
impedance

900 Ω pacing
impedance

DDD, 0% Off 15.8 15.8 15.8 15.8 15.8 15.8

On 15.7 15.7 15.7 15.7 15.7 15.7

DDD, 15%

Off 14.6 13.6 14.8 13.9 15.1 14.4

On 14.5 13.5 14.7 13.8 15.0 14.3

DDD, 50%

Off 12.4 10.2 12.8 10.8 13.6 11.9

On 12.3 10.1 12.7 10.7 13.5 11.9

AAI<=>DDD
(MVP Mode)
50% Atrial,

Off 13.7 12.1 14.0 12.6 14.5 13.4

On 13.6 12.1 13.9 12.5 14.4 13.3

5% Ventricular

DDD, 100%

Off 10.2 7.5 10.8 8.1 12.0 9.6

On 10.1 7.4 10.7 8.1 11.9 9.5

a

The data provided for programming Pre-arrhythmia EGM storage to On is based on a 6-month period (two
3-month follow-up intervals) over the life of the device. Additional use of Pre-arrhythmia EGM storage reduces
projected service life by approximately 12.1% or 1.4 months per year.

Note: These projections are based on typical shelf storage time (5 months). Assuming worst-case shelf storage
time (18 months), longevity is reduced by approximately 7%.

Note: The Capture Management feature can independently adapt each pacing amplitude value. An Atrial Pacing
Amplitude of 1.5 V and an RV Pacing Amplitude of 2.0 V represent typical values when using the Capture
Management feature. At these settings, and with 100% ventricular pacing (at 60 bpm, 0.4 ms, and 600 Ω), the
projected service life of the device is 12.6 years.

Medtronic remote monitor transmissions – Additional remote monitoring transmissions reduce the projected
service life of the device. For example, from nominal pacing (at 2.5 V, 0.4 ms, 600 Ω, 60 bpm, 100% atrial and
ventricular pacing), a patient can expect a projected service life of 10.7 years. More frequent remote monitoring
transmissions will reduce this projected service life as follows:

●

Monthly transmissions over the life of the device reduce projected service life by 16 days, or <1%.

●

Weekly transmissions over the life of the device reduce projected service life by 87 days, or 2.2%.

●

Daily transmissions over the life of the device reduce projected service life by 564 days, or 14.4%.

Table 9. Projected service life in years per conditions specified in EN 45502-2-1 and ISO 14708-2

EN 45502-2-1 ISO 14708-2

500 Ω ±1% pacing impedance
70 bpm

600 Ω ±1% pacing impedance
60 bpm

Pacing

DDDR, 100%

2.5 V, 0.5 ms 8.7

5.0 V, 0.5 ms 3.8

a

a

—

—

25

Table 9. Projected service life in years per conditions specified in EN 45502-2-1 and ISO 14708-2 (continued)

EN 45502-2-1 ISO 14708-2

2.5 V, 0.4 ms — 10.7

5.0 V, 0.4 ms — 5.5

a

Data storage and diagnostic functions applicable to the pacing mode are On.

a

a

6 Device parameters

6.1 Emergency settings

Table 10. Emergency VVI settings

Parameter Selectable values

Pacing Mode VVI

Lower Rate 70 bpm

RV Amplitude

RV Pulse Width

RV Pace Polarity Unipolar

V. Blank Post VP 240 ms

Rate Hysteresis Off

V. Rate Stabilization Off

MRI SureScan Off

a

If the programmed RV Amplitude is 8 V, VVI pacing is delivered at 8 V with a pulse width of 1.2 ms.

a

a

6 V

1.5 ms

6.2 Magnet application

When a magnet is placed near the device, the pacing mode changes from the programmed mode to DOO, VOO,
or AOO, and the pacing rate changes to 100 bpm for 5 beats and then changes to 85 bpm or 65 bpm, as described
at the end of this section. Placing a magnet near the device suspends tachyarrhythmia detection. When the
magnet is removed, the device returns to its programmed operation.

Note: Magnet operation does not occur if telemetry between the device and programmer is established or if the
MRI SureScan mode is programmed to On.

The pacing mode will be DOO when the programmed pacing mode is a dual chamber mode or an MVP mode
(AAIR<=>DDDR, AAI<=>DDD), VOO when the programmed pacing mode is a single chamber ventricular mode,
and AOO when the programmed pacing mode is a single chamber atrial mode.

The pacing rate will be 85 bpm if the device conditions are normal and it will be 65 bpm if a Recommended
Replacement Time (RRT) indicator or a device reset has occurred.

26

6.3 Tachyarrhythmia detection parameters

Table 11. Tachyarrhythmia detection parameters

Parameter Programmable values Shipped Reset

AT/AF Detection On; Monitor Monitor Monitor

Zones 1 ; 2 — —

b,c

a

150; 160 … 350 … 450 ms 350 ms 350 ms

a

150; 160 … 200 … 250 ms 200 ms 200 ms

a

280; 290 … 400 … 500 ms 400 ms 400 ms

0.45; 0.60; 0.90; 1.20; 2.00; 2.80;

0.9 mV 2.8 mV

4.00; 5.60; 8.00; 11.30 mV
Bipolar: 0.9 mV
Unipolar: 2.80 mV

0.15; 0.30; 0.45; 0.60; 0.90; 1.20;

0.3 mV 0.45 mV

1.50; 1.80; 2.10; 4.0 mV; Off
Bipolar: 0.3 mV
Unipolar: 0.45 mV

AT/AF Interval (Rate)

Fast AT/AF Interval (Rate)

VT Monitor Monitor ; Off Monitor Off

VT Monitor Interval (Rate)

RV Sensitivity

b,d

Atrial Sensitivity

a

The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device
uses this truncated interval value when applying the programmed criteria and calculating interval averages.

b

This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing
operations.

c

The device complies with the requirements of ISO 14708-2 when the sensitivity threshold is programmed to

1.8 mV or higher.

d

The device complies with the requirements of ISO 14708-2 when the sensitivity threshold is programmed to

2.0 mV or higher.

6.4 Atrial tachyarrhythmia therapy parameters

Table 12. Atrial tachyarrhythmia therapy parameters

Parameter Programmable values Shipped Reset

Anti-Tachy Pacing (ATP)

Fast AT/AF Rx Status On; Off Off Off

Therapy Type Ramp; Burst+

Rx1: Ramp
Rx2: Burst+
Rx3: Ramp

AT/AF Rx Status On; Off Off Off

Therapy Type Ramp; Burst+

Rx1: Ramp
Rx2: Burst+
Rx3: Ramp

27

— —

— —

Table 12. Atrial tachyarrhythmia therapy parameters (continued)

Parameter Programmable values Shipped Reset

Burst+ parameters

Initial # S1 Pulses 1; 2; 3 … 11 … 15; 20; 25 — —

A-S1 Interval (%AA) 28; 31; 34; 38; 41 … 59; 63; 66; 69 … 84 ; 88;

91; 94; 97%

S1-S2 (%AA) 28; 31; 34; 38; 41 … 59; 63; 66; 69 … 81 ; 84;

— —

88; 91; 94; 97%; Off

S2-S3 Decrement 0; 10; 20 … 80 ms; Off — —

Interval Decrement 0; 10 ; 20; 30; 40 ms — —

# Sequences 1; 2; 3 … 10 — —

Ramp parameters

Initial # S1 Pulses 1; 2; 3 … 13 ; 14; 15; 20; 25 — —

A-S1 Interval (%AA)

Rx1 28; 31; 34; 38; 41 … 59; 63; 66 … 84; 88;

— —

91 ; 94; 97%

Rx2 28; 31; 34; 38; 41 … 59; 63; 66 … 84; 88;

— —

91 ; 94; 97%

Rx3 28; 31; 34; 38; 41 … 59; 63; 66 … 81 ; 84; 88;

— —

91; 94; 97%

Interval Decrement 0; 10 … 40 ms — —

# Sequences 1; 2; 3 … 10 — —

Stop Atrial Rx After (shared)

Rx/Lead Suspect…

Disable Atrial ATP if it

Yes ; No Yes Yes

accelerates V. rate?

Disable all atrial therapies

Yes ; No Yes No
if atrial lead position is
suspect? (Atrial Lead
Position Check)

Duration to Stop 12; 24; 48 ; 72 hr;

48 hr 48 hr

None

Episode Duration Before Rx Delivery

Episode Duration Before
ATP

0; 1 ; 2 … 5; 7; 10; 15; 20; 25; 30; 40; 50 min;

1; 2; 3; 4; 5; 6; 12; 24 hr

1 min 1 min

Reactive ATP

Rhythm Change On ; Off On On

Time Interval Off ; 2; 4; 7; 12; 24; 36; 48 hr Off Off

Shared A. ATP

A-A Minimum ATP Intervala100; 110; … 150 … 400 ms 150 ms 150 ms

A. Pacing Amplitude 1; 2; 3 …6 ; 8 V 6 V 6 V

28

Table 12. Atrial tachyarrhythmia therapy parameters (continued)

Parameter Programmable values Shipped Reset

A. Pacing Pulse Width 0.1; 0.2 … 1.5 ms 1.5 ms 1.5 ms

VVI Backup Pacing Off; On (Always); On (Auto-Enable) On (Auto-

Enable)

On (Auto­Enable)

VVI Backup Pacing Rate 60; 70 … 120 bpm 70 bpm 70 bpm

a

The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device
uses this truncated interval value when applying the programmed criteria and calculating interval averages.

6.5 Pacing parameters

Table 13. Modes, rates, and intervals

Parameter Programmable values Shipped Reset

Mode DDDR; DDD; AAIR<=>DDDR ;

AAI<=>DDD VVI
AAI<=>DDD; DDIR; DDI; AAIR; AAI;
VVIR; VVI; DOO; AOO; VOO; ODO

Mode Switch On ; Off On Off

Lower Rate

Upper Tracking Rate 80; 85 … 130 …175 bpm; 180; 190 …

a

30; 35 … 60 ; 70; 75 … 150 bpm 60 bpm

(1000 ms)

65 bpm
(920 ms)

130 bpm 120 bpm
210 bpm

Paced AV 30; 40 … 180 … 350 ms 180 ms 180 ms

Sensed AV 30; 40 … 150 … 350 ms 150 ms 150 ms

Maximum AV Interval limit Off ; 250; 260 … 500 Off Off

PVARP Auto ; 150; 160 … 500 ms Auto Auto

Minimum PVARP 150; 160 … 250 … 500 ms 250 ms 250 ms

A. Refractory Period 150; 160 … 310 … 500 ms 310 ms 310 ms

a

The corresponding Lower Rate interval can be calculated as follows: Lower Rate interval (ms) = 60,000/Lower
Rate.

Table 14. Atrial parameters

Parameter Programmable values Shipped Reset

Atrial Amplitude 0.5; 0.75 … 3.5 … 5; 5.5; 6; 8 V

a

3.5 V —

Atrial Pulse Width 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 … 1.5 ms 0.4 ms —

Atrial Sensitivity

b

Off; 0.15; 0.3; 0.45; 0.6; 0.9; 1.2; 1.5; 1.8;

0.3 mV 0.45 mV

2.1; 4.0 mV
Unipolar: 0.45 mV
Bipolar: 0.3 mV

Atrial Pace Polarity Bipolar; Unipolar Configure

Atrial Sense Polarity Bipolar; Unipolar Configure

c

c

—

Unipolar

29

Table 14. Atrial parameters (continued)

Parameter Programmable values Shipped Reset

Atrial Lead Monitor Monitor Only; Adaptive Monitor Only Monitor Only

Min Limit 200 ; 300; 400; 500 Ω 200 Ω 200 Ω

Max Limit 1000; 1500; 2000; 3000 Ω 3000 Ω 3000 Ω

a

When Atrial Amplitude is 8 V, Atrial Pulse Width must be less than 1.3 ms.

b

This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing
operations.

c

“Configure” is displayed when the device is automatically configuring the lead polarity at implant. It is not a
selectable value.

Table 15. RV parameters

Parameter Programmable values Shipped Reset

RV Amplitude 0.5; 0.75 … 3.5 … 5; 5.5; 6; 8 V

a

3.5 V 6 V

RV Pulse Width 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 … 1.5 ms 0.4 ms 1.5 ms

RV Sensitivity

b

0.45; 0.60; 0.90; 1.20; 2.00; 2.80; 4.00;

0.90 mV 2.80 mV

5.60; 8.00; 11.30 mV
Unipolar: 2.80 mV
Bipolar: 0.90 mV

RV Pace Polarity Bipolar; Unipolar Configure

RV Sense Polarity Bipolar; Unipolar Configure

c

c

Unipolar

Unipolar

RV Lead Monitor Monitor Only; Adaptive Monitor Only Monitor Only

Min Limit 200 ; 300; 400; 500 Ω 200 Ω 200 Ω

Max Limit 1000; 1500; 2000; 3000 Ω 3000 Ω 3000 Ω

a

When RV Amplitude is 8 V, RV Pulse Width must be less than 1.3 ms.

b

This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing
operations.

c

“Configure” is displayed when the device is automatically configuring the lead polarity at implant. It is not a
selectable value.

Table 16. Atrial Capture Management parameters

Parameter Programmable values Shipped Reset

Atrial Capture Management Adaptive ; Monitor; Off Adaptive Off

Atrial Amplitude Safety

1.5x; 2.0x ; 2.5x; 3.0x 2.0x 2.0x

Margin

Atrial Minimum Adapted

1.0; 1.5 ; 2.0; 2.5; 3.0; 3.5 V 1.5 V 1.5 V

Amplitude

Atrial Acute Phase Remain-

Off; 30; 60; 90; 120 ; 150 days 120 days 120 days

ing

30

Table 17. RV Capture Management parameters

Parameter Programmable values Shipped Reset

RV Capture Management Adaptive ; Monitor; Off Adaptive Off

RV Amplitude Safety Mar-

1.5x; 2.0x ; 2.5x; 3.0x 2.0x 2.0x

gin

RV Minimum Adapted

1.0; 1.5; 2.0 ; 2.5; 3.0; 3.5 V 2 V 2 V

Amplitude

RV Acute Phase Remaining Off; 30; 60; 90; 120 ; 150 days 120 days 120 days

Table 18. Blanking periods

Parameter Programmable values Shipped Reset

PVAB Interval 10a; 20 … 100; 110; 120 …150 … 300 ms 150 ms 150 ms

PVAB Method Partial ; Partial+; Absolute Partial Partial

A. Blank Post AP 150; 160 … 200 … 250 ms 200 ms 240 ms

A. Blank Post AS 100 ; 110 … 170 ms 100 ms 100 ms

V. Blank Post VP 150; 160 … 200 … 320 ms 200 ms 240 ms

V. Blank Post VS 120 ; 130 … 170; 200; 220; 250; 280; 300;

120 ms 120 ms

320 ms

a

If the PVAB Method is set to Partial, the minimum selectable value for the PVAB Interval is 100 ms

Table 19. Rate Response Pacing parameters

Parameter Programmable values Shipped Reset

Upper Sensor Rate 80; 85 … 130 … 175 bpm 130 bpm 120 bpm

ADL Rate 60; 65 … 95 … 170 bpm 95 bpm 95 bpm

Rate Profile Optimization On ; Off On Off

ADL Response 1; 2; 3 ; 4; 5 3 3

Exertion Response 1; 2; 3 ; 4; 5 3 3

Activity Threshold Low ; Medium Low; Medium High; High Low Medium Low

Activity Acceleration 15; 30 ; 60 s 30 s 30 s

Activity Deceleration Exercise ; 2.5; 5; 10 min Exercise 5 min

ADL Setpoint 5; 6 … 40; 42 … 80 18 18

UR Setpoint 15; 16 … 40; 42 … 80; 85 … 180 40 40

Table 20. Rate Adaptive AV parameters

Parameter Programmable values Shipped Reset

Rate Adaptive AV Off ; On Off On

Start Rate 50; 55 … 90 … 145 bpm 90 bpm 60 bpm

Stop Rate 55; 60 … 130 … 175 bpm 130 bpm 120 bpm

31

Table 20. Rate Adaptive AV parameters (continued)

Parameter Programmable values Shipped Reset

Minimum Paced AV 30; 40 … 140 … 200 ms 140 ms 140 ms

Minimum Sensed AV 30; 40 … 110 … 200 ms 110 ms 110 ms

Table 21. Atrial Rate Stabilization parameters

Parameter Programmable values Shipped Reset

A. Rate Stabilization On; Off Off Off

Maximum Rate 80; 85 … 100 … 150 bpm 100 bpm 100 bpm

Interval Percentage Incre­ment

Table 22. Atrial Preference Pacing parameters

Parameter Programmable values Shipped Reset

A. Preference Pacing On; Off Off Off

Maximum Rate 80; 85 … 100 … 150 bpm 100 bpm 100 bpm

Interval Decrement 30 ; 40; 50 … 100; 150 ms 30 ms 50 ms

Search Beats 5; 10; 15; 20 ; 25; 50 20 5

12.5; 25 ; 50% 25% 25%

Table 23. Post Mode Switch Overdrive Pacing (PMOP) parameters

Parameter Programmable values Shipped Reset

Post Mode Switch On; Off Off Off

Overdrive Rate 70; 75; 80 … 120 bpm 80 bpm 65 bpm

Overdrive Duration 0.5; 1; 2; 3; 5 ; 10; 20; 30; 60; 90; 120 min 5 min 5 min

Table 24. Conducted AF Response parameters

Parameter Programmable values Shipped Reset

Conducted AF Response On; Off Off Off

Response Level Low; Medium ; High Medium Medium

Maximum Rate 80; 85 … 110 … 130 bpm 110 bpm 110 bpm

Table 25. Ventricular Rate Stabilization parameters

Parameter Programmable values Shipped Reset

V. Rate Stabilization On; Off Off Off

Maximum Rate 80; 85 … 100 …120 bpm 100 bpm 120 bpm

Interval Increment 100; 110 … 150 … 400 ms 150 ms 150 ms

32

Table 26. Rate Drop Response parameters

Parameter Programmable values Shipped Reset

Rate Drop Response

a

On; Off Off Off

Detection Type Drop ; Low Rate; Both Drop Drop

Drop Detection

Drop Size 10; 15 … 25 … 50 bpm 25 bpm 25 bpm

Drop Rate 30; 40 … 60 … 100 bpm 60 bpm 60 bpm

Detection Window 10; 15; 20; 25; 30 s

1 min 1 min

1 ; 1.5; 2; 2.5 min

Low Rate Detection

Detection Beats 1; 2; 3 beats 3 beats 3 beats

Intervention

Intervention Rate 70; 75 … 100 … 150 bpm 100 bpm 100 bpm

Intervention Duration 1; 2 … 15 min 2 min 2 min

a

When Rate Drop Response is set to On, the lower rate is automatically set to 45 bpm.

Table 27. Sleep parameters

Parameter Programmable values Shipped Reset

Sleep On; Off Off Off

Sleep Rate 30; 35 … 50 ; 55; 60; 70; 75 … 100 bpm 50 bpm 50 bpm

Bed Time 00:00; 00:10 … 22:00 … 23:50 22:00 22:00

Wake Time 00:00; 00:10 … 07:00 … 23:50 07:00 07:00

Table 28. Non-Competitive Atrial Pacing (NCAP) parameters

Parameter Programmable values Shipped Reset

Non-Comp Atrial Pacing On ; Off On On

NCAP Interval 200; 250; 300 ; 350; 400 ms 300 ms 300 ms

Table 29. MRI SureScan parameters

Parameter Programmable values Shipped Reset

MRI SureScan On; Off Off Off

MRI Pacing Mode DOO; AOO; VOO; ODO — —

MRI Pacing Rate 60; 70; 75; 80 … 120 bpm — —

Table 30. Additional pacing features

Parameter Programmable values Shipped Reset

PMT Intervention On; Off Off Off

PVC Response On ; Off On On

33

Table 30. Additional pacing features (continued)

Parameter Programmable values Shipped Reset

V. Safety Pacing On ; Off On On

Rate Hysteresis Off ; 30; 40 … 80 bpm Off Off

6.6 Data collection parameters

Table 31. Data collection parameters

Parameter Programmable values Shipped Reset

EGM 1 Source Can to Aring; Can to RVring; Atip to Aring ;

Atip to Aring Atip to Aring
Atip to RVring; Atip to Can; Aring to RVring;
RVtip to RVring; RVtip to Can

EGM 1 Range ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mV ±8 mV ±8 mV

EGM 2 Source Can to RVring; RVtip to RVring ; RVtip to

RVtip to RVring RVtip to RVring
Can

EGM 2 Range ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mV ±8 mV ±8 mV

EGM 3 Source RVtip to RVring; Can to RVring ; Atip to

Can to RVring Can to RVring
RVring; Atip to Aring; Can to Aring

EGM 3 Range ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mV ±8 mV ±8 mV

Monitored EGM1 and EGM2 ; EGM1 and EGM3;

EGM2 and EGM3

Pre-arrhythmia
EGM

Off ; On – 1 month; On – 3 months; On Con­tinuous

EGM1 and

EGM1 and EGM2

EGM2

Off Off

Device Date/Timea(select Time Zone) — —

Holter Telemetry Off ; 0.5; 1; 2; 4; 8; 16; 24; 36; 46 hr Off Off

Wireless Teleme-

On; Off On On

b

try with Monitor

a

The times and dates stored in episode records and other data are determined by the Device Date/Time clock.

b

The reset value may be set to Off if there is an issue with wireless communication that requires it to be disabled.

6.7 Medtronic CareAlert parameters

Table 32. Clinical Management Alerts

Parameter Programmable values Shipped Reset

AT/AF Burden and Rate Settings…

AT/AF Alerts

AT/AF Daily Burden Enable Off ; On Off Off

Daily AT/AF Burden (hr/24hr) 0.5; 1; 2; 6 ; 12; 24 hr/24 hr 6 hr 6 hr

Avg. V. Rate During AT/AF Ena­ble

Daily Burden for Avg. V. Rate
(hr/24hr)

Off ; On Off Off

0.5; 1; 2; 6 ; 12; 24 hr/24 hr 6 hr 6 hr

34

Table 32. Clinical Management Alerts (continued)

Parameter Programmable values Shipped Reset

Avg. V. Rate During AT/AF

90; 100 … 150 bpm 100 bpm 100 bpm

(bpm)

Monitored VT Episode Detec-

Off ; On Off Off

ted

Cumulative Right Ventricular
Pacing > 40%

a

There is no observation for Cumulative Right Ventricular Pacing > 40%.

b

Alert triggered if cumulative percent of right ventricular pacing exceeds 40% for 7 consecutive days.

a

Off ; On

b

Off Off

Table 33. Lead/Device Integrity Alerts

Parameter Programmable values Shipped Reset

Low Battery Voltage RRT On ; Off On Off

Lead Impedance Out of Range…

Lead Impedance

A. Pacing Enable On ; Off On Off

A. Pacing Less than 200 ; 300; 400; 500 Ω 200 Ω 200 Ω

A. Pacing Greater than 1000; 1500; 2000; 3000 Ω 3000 Ω 3000 Ω

RV Pacing Enable On ; Off On Off

RV Pacing Less than 200 ; 300; 400; 500 Ω 200 Ω 200 Ω

RV Pacing Greater than 1000; 1500; 2000; 3000 Ω 3000 Ω 3000 Ω

Capture Management High Threshold

High Threshold

A. Capture Enable

RV Capture Enable

a

If programmed to On, alert notification is sent if A. capture management has measured high thresholds for 3

a

b

Off ; On Off Off

Off ; On Off Off

consecutive days.

b

If programmed to On, alert notification is sent if RV capture management has measured high thresholds for 3
consecutive days.

6.8 System test parameters

Table 34. System test parameters

Parameter Selectable values

Pacing Threshold Test parameters

Test Type Amplitude; Pulse Width

Chamber Atrium; RV

Decrement after 2; 3 … 15 pulses

Modea (RV test) VVI; VOO; DDI; DDD; DOO

Modea (Atrium test) AAI; AOO; DDI; DDD; DOO

35

Table 34. System test parameters (continued)

Parameter Selectable values

Lower Rate 30; 35 … 60; 70; 75 … 150c bpm

RV Amplitude 0.25; 0.5 … 5; 5.5; 6; 8 V

RV Pulse Width 0.03; 0.06; 0.1; 0.2 … 1.5 ms

A. Amplitude 0.25; 0.5 … 5; 5.5; 6; 8 V

A. Pulse Width 0.03; 0.06; 0.1; 0.2 … 1.5 ms

AV Delay

b

30; 40 … 350 ms

V. Pace Blanking 150; 160 … 320 ms

A. Pace Blanking 150; 160 … 250 ms

PVARP 150; 160 … 500 ms

Pace Polarity Unipolar; Bipolar

Sensing Test parameters

a

Mode

AV Delay

Lower Rate

a

The selectable values for this parameter depend on the programmed pacing mode.

b

The selectable values for this parameter depend on the programmed Lower Rate.

c

When performing the test in DDD mode, the Lower Rate must be less than the programmed Upper Tracking

b

c

AAI; DDD; DDI; VVI; ODO

30; 40 … 350 ms

30; 35 … 60; 70; 75 … 120 bpm

Rate.

6.9 EP Study parameters

Table 35. 50 Hz Burst induction parameters

Parameter Selectable values

50 Hz Burst induction parameters

Resume at Burst Enabled ; Disabled

Amplitude 1; 2; 3; 4 ; 5; 6; 8 V

Pulse Width 0.10; 0.20 … 0.50 …1.50 ms

VOO Backup On; Off

Pacing Rate 60; 70 …120 bpm

V. Amplitude

V. Pulse Width

a

The default value for this parameter is set according to the permanently programmed settings for bradycardia
pacing.

Table 36. Fixed Burst induction parameters

Parameter Selectable values

Resume at Burst Enabled ; Disabled

Chamber RV; Atrium

a

a

0.50; 0.75 … 5.00; 5.50; 6.00; 8.00 V

0.10; 0.20 … 1.50 ms

36

Table 36. Fixed Burst induction parameters (continued)

Parameter Selectable values

Interval 100; 110 … 600 ms

Amplitude 1; 2; 3; 4 ; 5; 6; 8 V

Pulse Width 0.10; 0.20 … 0.50 … 1.50 ms

VVI Backup (for atrial Fixed Burst)

a

On; Off

Pacing Rate 60; 70 … 120 bpm

V. Amplitude

V. Pulse Width

a

Crosstalk may occur when atrial pacing amplitude is greater than 6 V.

b

The default value for this parameter is set according to the permanently programmed settings for bradycardia

b

b

0.50; 0.75 … 5.00; 5.50; 6.00; 8.00 V

0.10; 0.20 … 1.50 ms

pacing.

Table 37. PES induction parameters

Parameter Selectable values

Resume at Deliver Enabled ; Disabled

Chamber RV; Atrium

#S1 1; 2 … 8 … 15

S1S1 100; 110 … 600 … 2000 ms

S1S2 Off; 100; 110 … 400 … 600 ms

S2S3 Off ; 100; 110 … 600 ms

S3S4 Off ; 100; 110 … 600 ms

Amplitude 1; 2; 3; 4 ; 5; 6; 8 V

Pulse Width 0.10; 0.20 …0.50 … 1.50 ms

VVI Backup (for atrial PES)

a

On; Off

Pacing Rate 60; 70 … 120 bpm

V. Amplitude

V. Pulse Width

a

Crosstalk may occur when atrial pacing amplitude is greater than 6 V.

b

The default value for this parameter is set according to the permanently programmed settings for bradycardia

b

b

0.50; 0.75 … 5.00; 5.50; 6.00; 8.00 V

0.10; 0.20 … 1.50 ms

pacing.

Table 38. Shared manual ATP therapy parameters

Parameter Selectable values

Minimum Interval (atrial ATP) 100; 110; 120; 130 … 400 ms

Minimum Interval (ventricular ATP) 150; 160 … 200 … 400 ms

Amplitude 1; 2 … 6 ; 8 V

Pulse Width 0.10; 0.20 …1.50 ms

37

Table 38. Shared manual ATP therapy parameters (continued)

Parameter Selectable values

VVI Backup (for atrial ATP therapy)

a

On; Off

Pacing Rate 60; 70 … 120 bpm

V Amplitude

V Pulse Width

a

Crosstalk may occur when atrial pacing amplitude is greater than 6 V.

b

The default value for this parameter is set according to the permanently programmed settings for bradycardia

b

b

0.50; 0.75 … 5.00; 5.50; 6.00; 8.00 V

0.10; 0.20 … 1.50 ms

pacing.

Table 39. Manual Ramp therapy parameters

Parameter Selectable values

Chamber Atrium; RV

RV Ramp therapy parameters

# Pulses 1; 2 … 6 … 15

%RR Interval 50; 53; 56; 59; 63; 66 … 84; 88; 91; 94; 97 %

Dec/Pulse 0; 10 ; 20; 30; 40 ms

Atrial Ramp therapy parameters

# Pulses 1; 2 … 6 … 15; 20; 30 … 100

%AA Interval 28; 31; 34; 38; 41 … 59; 63; 66 … 84; 88; 91; 94; 97 %

Dec/Pulse 0; 10 ; 20; 30; 40 ms

Table 40. Manual Burst therapy parameters

Parameter Selectable values

# Pulses 1; 2 … 8 … 15

%RR Interval 50; 53; 56; 59; 63; 66 … 84; 88 ; 91; 94; 97%

Table 41. Manual Ramp+ therapy parameters

Parameter Selectable values

# Pulses 1; 2; 3 … 15

R-S1 (%RR) 50; 53; 56; 59; 63; 66 … 75 … 84; 88; 91; 94; 97%

S1-S2 (%RR) 50; 53; 56; 59; 63; 66; 69 … 84; 88; 91; 94; 97%

S2-SN (%RR) 50; 53; 56; 59; 63; 66 … 84; 88; 91; 94; 97%

Table 42. Manual Burst+ therapy parameters

Parameter Selectable values

#S1 Pulses 1; 2 … 6 … 15; 20; 30 … 100

%AA Interval 28; 31; 34; 38; 41 … 59; 63; 66 … 84; 88; 91 ; 94; 97%

38

Table 42. Manual Burst+ therapy parameters (continued)

Parameter Selectable values

S1S2 Off; 28; 31; 34; 38; 41 … 59; 63; 66 … 84 ; 88; 91; 94;

97%

S2S3 Dec Off; 0; 10; 20 … 80 ms

6.10 Nonprogrammable parameters

Table 43. Nonprogrammable parameters

Parameter Value

Premature event threshold for counting PVCs and Runs of PVCs 69%

Fixed blanking periods

Atrial blanking after a paced ventricular event (bipolar atrial sensing) 30 ms

Atrial blanking after a paced ventricular event (unipolar atrial sensing) 40 ms

Ventricular blanking after a paced atrial event (bipolar ventricular sensing) 30 ms

Ventricular blanking after a paced atrial event (unipolar ventricular sens­ing)

Fixed bradycardia pacing parameters

Ventricular Safety Pacing intervals

PVARP value applied by PVC Response and PMT Intervention

NCAP value applied by PVC Response and PMT Intervention

b

c

d

Fixed automatic atrial ATP therapy parameters

VVI Backup Pacing amplitude 6 V

VVI Backup Pacing pulse width 1.5 ms

Fixed EP study parameters

50 Hz burst pacing interval 20 ms

Hardware parameters

Pacing rate limite (protective feature) 200 bpm

Input impedance 150 kΩ minimum

Effective pacing capacitance 4 µF

Recommended Replacement Time (RRT)

a

40 ms

110 ms

400 ms

400 ms

f

Battery Voltage Threshold ≤ 2.63 V

a

35 ms when the ventricular pacing amplitude is programmed to 8 V.

b

The VSP interval may be shortened from 110 ms to 70 ms automatically by the device at higher pacing rates
when necessary to help support ventricular tachycardia detection.

c

PVARP is extended to 400 ms only if the current PVARP is less than 400 ms.

d

The NCAP extension applies only if NCAP is enabled.

e

Does not apply during ATP therapies or ventricular safety pacing.

f

If the Upper Tracking Rate is programmed to a value greater than 180 bpm, the pacing rate limit is 230 bpm.

39

Table 44. Nonprogrammable parameters for the MRI SureScan mode

Parameter Value

Pacing amplitude Programmed pacing amplitude value when >5 V;

5 V when programmed pacing amplitude value is ≤5 V

Pulse width Programmed pulse width value when >1 ms;

1 ms when programmed pulse width value is ≤ 1 ms

Sensitivity Programmed value

Input impedance 150 kΩ

AV interval Programmed PAV value when PAV is ≥50 ms and

≤100 ms;
50 ms when PAV is <50 ms;
110 ms when PAV is >110 ms

Pacing rate limit 200 bpm

Effective pacing capacitance 4 µF

Refractory period —

Blanking period

ODO mode Programmed blanking period value

DOO, VOO, and AOO modes —

40

Medtronic, Inc.

*M994942A001*

710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
[phone]

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
Bradycardia: [phone]
Tachycardia: [phone]

Technical manuals

www.medtronic.com/manuals

© 2019 Medtronic
M994942A001 A
2019-04-15