Medtronic BLEIMPLANT2 User Manual
Percepta™ Quad CRT-P MRI SureScan™ W4TR01
MR Conditional pacemaker with cardiac resynchronization therapy, 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.
AdaptivCRT, Advisa, Advisa DR MRI, Capture Management, Cardiac Compass, CardioSync, CareAlert,
CareLink, EffectivCRT, EnPulse, EnRhythm, EnRhythm MRI, Flashback, GEM, GEM III, InSync,
InSync II Marquis, InSync III Marquis, InSync Marquis, Kappa, Marquis, Medtronic, Medtronic AT500,
Medtronic CareAlert, Medtronic CareLink, MVP, OptiVol, Percepta, Quick Look, Reactive ATP, Revo MRI,
SureScan, TherapyGuide, VectorExpress
Contents
1 System overview 4
1.1 Introduction 4
1.2 System description 4
1.3 Indications and usage 5
1.4 Contraindications 5
1.5 MRI conditions for use 6
1.6 Feature summary 7
1.7 Data security 10
2 Warnings, precautions, and potential adverse events 10
2.1 General warnings and precautions 10
2.2 Explant and disposal 10
2.3 Handling and storage instructions 11
2.4 Lead evaluation and lead connection 11
2.5 Device operation 12
2.6 Potential adverse events 14
3 Clinical data 15
3.1 Adverse events and clinical trial data 15
4 Implant procedure 16
4.1 Preparing for an implant 16
4.2 Selecting and implanting the leads 18
4.3 Testing the lead system 19
4.4 Connecting the leads to the device 20
4.5 Positioning and securing the device 21
4.6 Completing the implant procedure 22
4.7 Replacing a device 23
5 Product specifications 24
5.1 Physical characteristics 24
5.2 Electrical specifications 25
5.3 Replacement indicators 26
5.4 Projected service life 27
6 Device parameters 29
6.1 Emergency settings 29
6.2 Magnet application 29
6.3 Tachyarrhythmia detection parameters 29
6.4 Atrial tachyarrhythmia therapy parameters 30
6.5 Pacing parameters 32
6.6 Data collection parameters 38
6.7 Medtronic CareAlert parameters 39
6.8 System test parameters 40
6.9 EP study parameters 42
6.10 Nonprogrammable parameters 45
3
1 System overview
1.1 Introduction
This manual describes the Medtronic Model W4TR01 Percepta Quad CRT-P MRI SureScan dual chamber,
implantable pulse generator with cardiac resynchronization therapy (CRT-P). The manual contains model-specific
feature information, indications and contraindications, warnings and precautions, instructions for implanting the
device, quick reference specifications, and parameter tables.
Additional manuals and documents with 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 CRT-P 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 Percepta Quad CRT-P MRI SureScan Model W4TR01 dual chamber implantable pulse generator
with cardiac resynchronization therapy (CRT-P) is a multiprogrammable cardiac device that monitors and
regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing,
sequential biventricular pacing, and atrial tachyarrhythmia therapies. This device features Bluetooth wireless
technology.
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.
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.
1
1
The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by
Medtronic is under license.
4
●
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 with cardiac
resynchronization therapy (CRT-P) and 1 torque wrench.
Implantable device system – The Percepta Quad CRT-P MRI SureScan Model W4TR01 device and the pacing
leads constitute the implantable portions of the device system.
Leads – The lead system used with this device must provide pacing to the left ventricle (LV), sensing and pacing
to the right ventricle (RV), and sensing and pacing 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 18.
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 Percepta Quad CRT-P MRI SureScan system is indicated for:
●
NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal medical therapy
and have LVEF ≤ 35% and a prolonged QRS duration.
●
NYHA Functional Class I, II, or III patients who have LVEF ≤ 50%, are on stable, optimal heart failure medical
therapy if indicated and have atrioventricular block (AV block) that are expected to require a high percentage
of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing.
Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should
be done post implant.
Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from
increased pacing rates concurrent with increases in activity.
Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV
synchrony.
Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmia in patients with one or more of
the above pacing indications.
1.4 Contraindications
The Percepta Quad CRT-P MRI SureScan system is contraindicated for:
●
Concomitant implant with another bradycardia device
●
Concomitant implant with an implantable cardioverter defibrillator
5
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 or a Model 6725 pin plug for
the right atrial port. 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 at a pacing output of 5.0 V and at a pulse
width of 1.0 ms.
Note: The LV lead is not paced during SureScan operation, so the presence of diaphragmatic stimulation on
the LV lead at a pacing output of 5.0 V and a pulse width of 1.0 ms does not need to be considered.
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 an MRI scan.
●
In the event that patient rescue is required, an external defibrillator must be immediately available.
6
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 29.
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.
Auto-adjusting sensitivity – This feature automatically adjusts the sensitivity thresholds after specific paced
events and sensed events occur.
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 and cardiac resynchronization features
AdaptivCRT – This feature adjusts CRT parameter values automatically while the patient is ambulatory. If the
AdaptivCRT feature is programmed to Adaptive Bi-V and LV, the feature can switch automatically between
biventricular pacing and LV-only pacing.
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
atrial and RV 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.
Cardiac resynchronization therapy (CRT) recovery options – There are 5 programmable features that help
maintain CRT:
●
Ventricular Sense Response triggers ventricular pacing in response to ventricular sensing to ensure that
CRT pacing is delivered as programmed.
●
Conducted AF Response dynamically adjusts and smooths the pacing rate to promote CRT delivery in the
presence of sensed ventricular events in non-tracking modes.
●
Atrial Tracking Recovery temporarily shortens PVARP to restore atrial tracking and CRT delivery if atrial
tracking is lost due to PVCs or due to an atrial rhythm that is too fast to be tracked to the ventricle.
●
EffectivCRT during AF dynamically adjusts the pacing rate in response to changes in the percentage of
effective CRT pacing to promote CRT delivery in nontracking modes.
7
●
Multiple point pacing (MPP) enables the device to deliver two LV pulses per pace, either simultaneously or
with a programmable delay, to two pacing vectors. Each LV pulse can be programmed with its own amplitude
and pulse width.
CardioSync Optimization Test – This feature measures the patient’s intrinsic AV intervals and the waveform
widths of the P-wave and QRS complex. Based on the measurements, the test provides optimized values for the
following CRT parameters: V. Pacing configuration, V-V Pace Delay, Paced AV, and Sensed AV.
CRT ventricular pacing options – The ventricular pacing configuration in the CRT device provides the
programming option for biventricular pacing or RV only pacing. The biventricular pacing sequence and V-V pace
delay are programmable as an additional means to improve hemodynamics.
LV Capture Management – This feature monitors the left ventricular pacing threshold with daily pacing threshold
searches and, if programmed to do so, adjusts the LV pacing amplitude toward a target amplitude.
LV Pacing Polarity – This feature provides 16 pacing polarities the clinician can select from to identify a pacing
polarity that provides capture at the desired site, maximizes device longevity, and avoids phrenic nerve stimulation.
The LV pacing polarity selections include 12 bipolar vectors and 4 unipolar vectors. The feature also enables the
clinician to change pacing location, if necessary, by programming pacing polarity. When the multiple point pacing
(MPP) feature is programmed On, the 2nd LV Pacing Polarity parameter provides additional pacing polarity
options.
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) – When the device is not pacing for CRT, the MVP feature can promote
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.
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.
Sequential biventricular pacing – The ventricular pacing sequence and V-V pace delay are programmable as
an additional means to improve hemodynamics during CRT therapy.
Sleep feature – This feature causes the device to pace at a slower rate during a programmed sleep period.
8
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. The report
also includes the OptiVol 2.0 fluid trend data.
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.
EffectivCRT episodes data – This feature compiles diagnostic information to help the clinician identify the cause
of ineffective CRT pacing and reprogram the device to avoid it. Data collected includes date and time, average
atrial and ventricular beats per minute, event markers, an indication of whether ATAF was present, and an
indication of which ventricular paces were effective.
Heart Failure Management Report – This report provides an overview of the patient’s condition over the short
and long term, with a focus on heart failure management. The report includes graphs that show OptiVol 2.0 fluid
trends and trends related to heart failure over the last 14 months.
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).
OptiVol 2.0 fluid trends – This feature provides the capability to monitor the following trends:
●
The Thoracic Impedance trend plots thoracic impedance for up to 14 months.
●
The OptiVol 2.0 Fluid Index trend plots the accumulated differences between the Daily Impedance and
Reference Impedance values. Possible fluid accumulation in the patient’s thoracic cavity exists when the
OptiVol 2.0 Fluid Index exceeds the OptiVol Threshold.
Rate Histograms report – This report shows heart rate range distributions for the patient.
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.
VectorExpress 2.0 LV Automated Test – This feature allows automated testing of clinician-selected pacing
polarities to determine the patient’s LV capture thresholds and pacing impedances. These test results are
displayed in the LV Test Results window. In addition, the device reports relative longevity information for tested LV
pacing polarities, results of clinician-conducted phrenic nerve stimulation threshold tests, and RV sense to LV
sense delay or RV pace to LV sense delay information for each LV electrode. The clinician then can filter, sort, and
9
view all test results, making it easier to decide on the appropriate LV pacing polarity, amplitude, and pulse width
settings for the patient. An LV Notes field is available for the clinician to record comments about test results and
their LV Pace Polarity selection for the patient.
Ventricular Sensing Episodes – This diagnostic records extended periods of ventricular sensing to help the
clinician assess the continuity of CRT delivery.
1.7 Data security
Medtronic has designed safeguards to protect patient information and device data for the
Percepta Quad CRT-P MRI SureScan Model W4TR01 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
A complete SureScan pacing system is required for use in the MR environment. Before performing an
MRI scan, refer to the MRI technical manual for MRI-specific warnings and precautions. A complete
SureScan pacing system includes a SureScan device with Medtronic SureScan leads or a Model 6725 pin plug for
the right atrial port. Any other combination may result in a hazard to the patient during an MRI scan.
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 – Do not use another manufacturer’s leads without demonstrated compatibility with
Medtronic devices. If a lead is not compatible with a Medtronic device, the result may be undersensing of cardiac
activity, failure to deliver necessary therapy, or a leaking or intermittent electrical connection.
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.
10
●
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.
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 device 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.
11
Lead connection – Consider the following information when connecting the lead and the device:
●
Cap abandoned leads to avoid transmitting electrical signals.
●
If an atrial lead is not used, plug the unused atrial lead port with a Medtronic Model 6725 IS-1 connector port
pin plug to protect the device.
●
Verify lead connections. Loose lead connections may result in inappropriate sensing and failure to deliver
arrhythmia therapy.
2.5 Device operation
Leads – Bipolar or unipolar atrial and right ventricular leads may be used with the
Percepta Quad CRT-P MRI SureScan Model W4TR01 device, but if leads other than bipolar MRI SureScan leads
are used, the system is contraindicated for MRI scans. The left ventricular lead must be a quadripolar lead, but if
it is not a quadripolar MRI SureScan lead, 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 reset – Device 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 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.
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.
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
12
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.
Multiple point pacing (MPP) – Battery longevity is shortened when the MPP feature is programmed to On.
Pace polarity – Pace polarity must be bipolar to program the MRI SureScan mode to On.
Pacemaker-mediated tachycardia (PMT) 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.
Phrenic nerve stimulation – Phrenic nerve stimulation may occur as a result of left ventricular pacing at higher
amplitudes. Although this condition is not life threatening, it is recommended that you test for phrenic nerve
stimulation at various pacing amplitude settings with the patient in various positions. If phrenic nerve stimulation
occurs with the patient, determine the minimum pacing threshold for phrenic nerve stimulation and program the
pacing amplitude to a value that minimizes stimulation but provides an adequate pacing safety margin. Also,
consider the use of alternate left ventricular pacing vectors to alleviate phrenic nerve stimulation. If the LV Capture
Management or 2nd LV Capture Management features are used, program the LV Maximum Adapted Amplitude or
2nd LV Maximum Adapted Amplitude to values that minimize phrenic nerve stimulation but provide an adequate
pacing safety margin. Carefully consider the relative risks of phrenic nerve stimulation versus loss of capture
before programming lower pacing amplitudes for the patient.
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. This is particularly
important when the lead is placed in the inferior atrium.
13
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 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
Potential adverse events associated with the use of transvenous leads and pacing systems include, but are not
limited to, the following events:
●
acceleration of tachyarrhythmias (caused by
device)
●
bleeding
●
cardiac dissection
●
cardiac tamponade
●
death
●
erosion
●
excessive fibrotic tissue growth
●
fibrillation or other arrhythmias
●
formation of hematomas or cysts
●
heart wall or vein wall rupture
●
infection
●
lead abrasion and discontinuity
●
muscle stimulation, nerve stimulation, or both
●
myocardial irritability
●
pericardial effusion
●
pneumothorax
●
threshold elevation
●
thrombolytic and air embolism
●
transvenous lead-related thrombosis
●
venous occlusion
●
air embolism
●
body rejection phenomena including local tissue
reaction
●
cardiac perforation
●
chronic nerve damage
●
endocarditis
●
erosion through the skin
●
extrusion
●
fluid accumulation
●
heart block
●
hematoma/seroma
●
keloid formation
●
lead migration/dislodgment
●
myocardial damage
●
myopotential sensing
●
pericardial rub
●
rejection phenomena (local tissue reaction,
fibrotic tissue formation, device migration)
●
thromboemboli
●
thrombosis
●
valve damage (particularly in fragile hearts)
●
venous or cardiac perforation
An additional potential adverse event associated with the use of transvenous left ventricular pacing leads is
coronary sinus dissection.
14
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:
AdaptivCRT (Adaptive Cardiac Resynchronization Therapy) clinical study – This clinical study evaluated
the safety and efficacy of the AdaptivCRT algorithm to provide patient-specific selection of LV or BiV CRT pacing
as well as dynamic adjustment of AV and VV delays based on periodic automatic evaluation of intrinsic electrical
conduction.
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
Percepta Quad CRT-P MRI SureScan Model W4TR01 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 Percepta Quad CRT-P MRI SureScan
Model W4TR01 devices. Note that the Ventricular Response Pacing (VRP) feature mentioned in the study is called
Conducted AF Response in Percepta Quad CRT-P MRI SureScan Model W4TR01 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
Percepta Quad CRT-P MRI SureScan Model W4TR01 devices.
BLOCK HF clinical study – The Biventricular versus Right Ventricular Pacing in Heart Failure Patients with
Atrioventricular Block Clinical Study investigated the safety and efficacy of biventricular pacing compared to right
ventricular pacing. This study provides support for biventricular pacing in Percepta Quad CRT-P MRI SureScan
Model W4TR01 devices.
Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee) Trial – This clinical study, which
evaluated the safety and efficacy of the EffectivCRT During AF feature, provides support for this feature in the
Percepta Quad CRT-P MRI SureScan Model W4TR01 devices.
Care-HF clinical study – This clinical study, which evaluated the effects of cardiac resynchronization therapy
(CRT) in InSync and InSync III devices on the mortality and morbidity of patients with moderate or severe heart
failure due to left ventricular systolic dysfunction and cardiac dyssynchrony, provides support for CRT pacing in
Percepta Quad CRT-P MRI SureScan Model W4TR01 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
Percepta Quad CRT-P MRI SureScan Model W4TR01 devices.
FAST study – This clinical study, which evaluated the OptiVol Fluid Monitoring feature in InSync Marquis devices
to corroborate the MIDHeFT clinical data, provides support for the OptiVol Fluid Monitoring feature in
Percepta Quad CRT-P MRI SureScan Model W4TR01 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
Percepta Quad CRT-P MRI SureScan Model W4TR01 devices.
15
Loading...