Medtronic MICSIMPLANT4 User Manual
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EV ICD DVEX3E4
Digital single chamber extravascular implantable cardioverter defibrillator (VVE-VVI) with
Antitachycardia Pacing (ATP), Pause Prevention, and Post-Shock Pacing
MR Conditional with PhysioCurve™ Design
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Device Manual
Caution: Investigational device. Limited by Federal law (USA) to investigational use.
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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.
Active Can, Cardiac Compass, CareAlert, CareLink, Conexus, Flashback, Integrity, Marker Channel,
Medtronic, Medtronic CareAlert, Medtronic CareLink, Patient Alert, PhysioCurve, Quick Look, SureScan,
T-Shock
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Contents
1 System overview 5
1.1 Introduction 5
1.2 Investigational notice 5
1.3 System description 5
1.4 Indications for use 6
1.5 Contraindications 6
1.6 Pre-implant consideration 6
1.7 MRI conditions for use 7
1.8 Feature summary 7
1.9 Data security 10
2 Warnings, precautions, and potential adverse events 10
2.1 General warnings and precautions 10
2.2 Explant and disposal 11
2.3 Handling and storage instructions 11
2.4 Lead evaluation and lead connection 12
2.5 Device operation 12
2.6 Warnings, precautions, and guidance for clinicians performing medical procedures on cardiac
device patients 13
2.7 Warnings, precautions, and guidance related to electromagnetic interference (EMI) for cardiac
device patients 16
2.8 Potential adverse events 18
3 Implant procedure 19
3.1 Preparing for an implant 19
3.2 Implanting the lead 20
3.3 Testing the lead system 21
3.4 Connecting the lead to the device 21
3.5 Positioning and securing the device 23
3.6 Performing a Sensing Test 24
3.7 Performing a pacing threshold test 25
3.8 Performing ventricular defibrillation threshold tests 25
3.9 Completing the implant procedure 27
4 Replacement procedure 28
4.1 Replacing a device 28
5 Product specifications 29
5.1 Physical characteristics 29
5.2 Electrical specifications 30
5.3 Replacement indicators 33
5.4 Projected service life 33
5.5 Energy levels and typical charge times 34
5.6 Magnet application 34
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6 Device parameters 34
6.1 Emergency settings 34
6.2 Tachyarrhythmia detection parameters 35
6.3 Ventricular tachyarrhythmia therapy parameters 36
6.4 Post shock pacing parameters 38
6.5 Pause Prevention Detection — detection and pacing parameters 39
6.6 Sensing parameters 39
6.7 MRI SureScan parameters 40
6.8 Medtronic CareAlert parameters 40
6.9 Data collection parameters 42
6.10 System test parameters 43
6.11 EP Study parameters 44
7 Explanation of symbols 45
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1 System overview
1.1 Introduction
This manual describes the Medtronic EV ICD Model DVEX3E4 single chamber, extravascular implantable
cardioverter defibrillator (ICD). It contains model-specific feature information, indications and contraindications,
warnings and precautions, instructions for implanting the device, quick reference specifications, and parameter
tables.
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. When programmed to On, MRI SureScan operation disables pacing, arrhythmia
detection and all user-defined diagnostics. Before performing an MRI scan, refer to the MRI Technical Manual.
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 and describes how to use a
programmer to conduct a session. The reference manual applies to multiple models of ICD devices.
Programming guide – This manual explains how to use the programmer software to conduct a patient session.
Radio regulatory compliance information – This document provides compliance information related to the
radio components of the device.
1.2 Investigational notice
The Medtronic EV ICD model DVEX3E4 implantable cardioverter defibrillator is under clinical investigation. The
procedures for using the device, as well as its safety and effectiveness, will be evaluated according to the Clinical
Investigation Plan. Therefore, the indications in this manual are based on the experience Medtronic has had with
similar devices. No claims of safety and effectiveness can be made for the model DVEX3E4 device during clinical
evaluation. Physicians should advise their patients that the model DVEX3E4 device is under clinical investigation.
1.3 System description
The Medtronic EV ICD model DVEX3E4 single chamber, implantable cardioverter defibrillator (ICD) is a
multiprogrammable cardiac device that monitors and regulates the patient’s heart rate. It provides ventricular
tachyarrhythmia detection and therapy, post-shock pacing, and prolonged pause detection and therapy (Pause
Prevention pacing).
The device also provides diagnostic and monitoring features to assist with system evaluation and patient care.
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.
1.3.1 Usage environments
The device is intended to be used in the following environments and conditions:
●
The device must be implanted in a properly equipped, staffed, and sterile surgical environment.
●
The device must be implanted under standard surgical protocols and in the patient population for which the
device is indicated.
●
Post-surgical patient and device follow-up care must be conducted in a properly equipped and staffed
cardiology clinic or office.
●
MRI procedures for patients with this device must be conducted in a properly equipped and staffed MR facility,
and in consideration of the conditions and requirements described in Section 1.7.
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●
After the device and lead are implanted, patients can resume their lives at home, at work, and in other
environments with consideration of the advice and restrictions documented in Section 2.6, “Warnings,
precautions, and guidance for clinicians performing medical procedures on cardiac device patients”,
page 13, Section 2.7, “Warnings, precautions, and guidance related to electromagnetic interference (EMI)
for cardiac device patients”, page 16, and in the patient literature.
1.3.2 System components and accessories
Contents of sterile package – The package contains 1 implantable cardioverter defibrillator and 1 torque
wrench.
Connector – The device has a Medtronic EV4 quadripolar inline connector. This connector facilitates the
connection of a Medtronic Model EV2401 EV4-LLHH extravascular quadripolar lead. EV4-LLHH is a Medtronic
proprietary design where the lead connector contacts are defined as low voltage (L) and high voltage (H). The
mechanical specifications for the EV4-LLHH connector are defined by the Medtronic EV4 connector specification.
Lead – The device is intended for implant with a Medtronic Model EV2401 EV4-LLHH extravascular quadripolar
lead. The Medtronic Model DVEX3E4 device can be used with EV4 labeled leads only. See Section 3.2,
“Implanting the lead”, page 20 for more information.
Implantable device system – The implantable device system includes the Medtronic EV ICD Model DVEX3E4
device connected to a Medtronic Model EV2401 EV4-LLHH extravascular quadripolar lead.
Programmers and software – The Medtronic programmer and software are used to program this device. Refer
to the reference manual for information about using the programmer.
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 can be used to measure some electrical
characteristics of the implanted lead prior to its attachment to the device.
Medtronic patient monitor – The Medtronic CareLink Network, if available, provides remote monitoring of
patients. Patients use the Medtronic patient monitor 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.
1.4 Indications for use
The Medtronic EV ICD model DVEX3E4 device is indicated for the automated treatment of patients who have
experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias.
1.5 Contraindications
The Medtronic EV ICD model DVEX3E4 device is contraindicated for patients with the following issues:
●
Ventricular tachyarrhythmias due to transient or reversible causes
●
Incessant VT or VF
●
Concomitant implant of a device delivering unipolar pacing
●
Concomitant implant of a device delivering dual-chamber or triple-chamber (CRT) pacing
●
Concomitant implant of a device delivering anti-tachyarrhythmia therapies
●
Symptomatic bradycardia
1.6 Pre-implant consideration
Patient evaluation for the implant of EV ICD model DVEX3E4 should include the following consideration about a
concomitant implant with a neurostimulator:
Concomitant neurostimulator and cardiac device implants – Some patients have medical conditions that
require the implant of both a neurostimulator and a cardiac device (for example, a pacemaker, a defibrillator, or a
monitor). In this case, physicians (for example, a neurologist, a neurosurgeon, a cardiologist, and a cardiac
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surgeon) involved with either device should contact Medtronic Technical Services or their Medtronic
representative before implanting the patient with the second device. Based on the particular devices that the
physicians have prescribed, Medtronic can provide the necessary precautions and warnings related to the implant
procedure. For information about how to contact Medtronic, see the telephone numbers and addresses provided
on the back cover of this manual.
1.7 MRI conditions for use
A complete SureScan defibrillation system is required for use in the MR environment. Before performing
an MR scan, refer to the MRI technical manual for MRI-specific warnings and precautions.
A complete SureScan system only includes components that have been certified by Medtronic as being MRI
conditional. 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 feature to On. Scanning the patient
without programming the MRI SureScan feature to On may result in patient harm or damage to the SureScan
defibrillation system.
Note: The MRI SureScan feature cannot be programmed to On if the device is recommended for replacement.
Patients and their implanted systems must be screened to meet the following requirements:
Cardiology 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 device is operating within the projected service life.
●
The device does not provide pacing therapy when SureScan mode is programmed to On. Do not scan
pacemaker-dependent patients.
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 while MRI SureScan is programmed to On.
In the event that patient rescue is required, an external defibrillator must be immediately available.
1.8 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 34.
1.8.1 Programmer software features
For more information about these features, see the reference manual.
Conexus wireless telemetry – This feature enables wireless transmission of data between an implanted device
and the programmer in the hospital or clinic and between an implanted device and a home monitor in the patient’s
home.
Emergency therapies – During a patient session, defibrillation and cardioversion can be initiated manually to
treat ventricular tachyarrhythmia episodes quickly.
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Live Rhythm Monitor – This window on the programmer displays ECG, LECG, Marker Channel (with marker
annotations), and telemetered EGM waveform traces. It also displays the patient heart rate and interval in the
upper left-hand corner of the window.
Patient Information – This feature allows clinicians to store patient-related information on the programmer that
they can view and print during a patient session.
1.8.2 Diagnostic data features
When MRI SureScan is programmed to On, diagnostic data is not collected. Before performing an MRI
scan, refer to the MRI technical manual for MRI-specific warnings and precautions.
For more information about these features, see the reference manual.
Arrhythmia episode data – The system compiles an arrhythmia episode log that the clinician can use to view
summary and detailed diagnostic data quickly, including stored EGM, for the selected arrhythmia episode. Also
available on the programmer are episode and therapy counters, stored data showing the number of times that
arrhythmias and therapies have occurred.
Cardiac Compass Trends – This feature presents an overview of the patient’s condition over the past 14 months
with graphs that display long-term clinical trends in heart rhythm and device status, such as frequency of
arrhythmias, heart rates, and device therapies.
Flashback Memory – This diagnostic feature records the intervals that immediately preceded tachyarrhythmia
episodes or that preceded the last interrogation of the device and plots the interval data over time.
Medtronic CareAlert events – If the device identifies any CareAlert programmed or automatic alert conditions,
this feature sounds a Patient Alert tone to notify the patient to seek medical attention.
Quick Look II – This screen on the programmer presents overview data about device operation and patient
rhythms collected since the last patient session. It includes links to more detailed status and diagnostic information
stored in the device, such as arrhythmia episodes and therapies provided.
Rate Histograms – This diagnostic feature shows range distributions for the patient’s heart rate.
1.8.3 Tachyarrhythmia detection features
When MRI SureScan is programmed to On, tachyarrhythmia detection and therapies are suspended.
Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and
precautions.
For more information about these features, see the reference manual.
Auto-adjusting sensitivity – This feature automatically adjusts sensitivity thresholds following specific paced
events and sensed events, according to configured parameters.
Feature Match – This feature prevents ventricular tachyarrhythmia detection for rapidly conducted SVTs whose
morphology features are similar to a template collected during sinus rhythm.
High Rate Timeout – This feature allows the device to deliver therapy for any ventricular tachyarrhythmia that
continues beyond the programmed length of time.
Morphology Noise – This feature withholds detection of ventricular tachyarrhythmias when the morphology on
the EGM2 channel shows noise.
Onset – This feature helps prevent the detection of sinus tachycardia as VT by evaluating the acceleration of the
ventricular rate.
Rapid AF – This feature withholds detection for rapid atrial fibrillation conducted into the ventricles with periodic
slow intervals that have consistent morphology and amplitudes.
Sensed EMI – This feature withholds ventricular tachyarrhythmia detection when noise is sensed during the
blanking periods.
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Sensed Noise – This feature withholds ventricular tachyarrhythmia detection when the device sees sensed noise,
but the EGM2 signal is free of noise.
Stability – This feature helps to prevent detection of atrial fibrillation as ventricular tachyarrhythmia by evaluating
the stability of the ventricular rate. If the device determines that the ventricular rate is not stable, it withholds VT
detection.
TWave Discrimination – This feature withholds VT/VF detection when a fast ventricular rate is detected because
of oversensed T-waves, avoiding the delivery of an inappropriate therapy.
VT/VF detection – This feature uses programmable detection zones to classify ventricular events. If the number
of tachyarrhythmia events in a zone exceeds a programmed threshold, the device detects a ventricular
tachyarrhythmia episode. Depending on programming, the device delivers a scheduled therapy, re-evaluates the
patient’s heart rhythm, and terminates or redetects the episode.
Wavelet – This feature is designed to prevent the detection of rapidly conducted SVTs as ventricular
tachyarrhythmias by comparing the shape of each QRS complex during a fast ventricular rate to a template. The
feature offers the option to collect and maintain the stored template automatically.
1.8.4 Tachyarrhythmia therapy features
When MRI SureScan is programmed to On, tachyarrhythmia detection and therapies are suspended.
Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and
precautions.
For more information about these features, see the reference manual.
Progressive Episodes Therapies – This feature causes the device to skip therapies or modify high-voltage
energy levels to ensure that each therapy delivered during an episode is at least as aggressive as the previous
therapy.
Ventricular antitachycardia pacing (ATP) therapies – ATP therapies respond to a VT episode or an FVT
episode with rapid sequences of pacing pulses to terminate detected ventricular tachyarrhythmias. Therapy
options include Burst and Ramp, each with a programmable number of sequences.
Ventricular cardioversion (CV) – This therapy delivers a high-voltage shock to treat a VT or FVT episode.
Therapy is synchronized to a sensed ventricular event.
Ventricular defibrillation (VF Therapies) – Programmable defibrillation therapy is available to treat VF
episodes. The first defibrillation therapy requires VF confirmation before delivery. If synchronization fails following
delivery of the first defibrillation therapy, subsequent therapies are delivered asynchronously.
1.8.5 Pacing features
When MRI SureScan is programmed to On, pacing features are suspended. Before performing an MRI
scan, refer to the MRI Technical Manual for MRI-specific warnings and precautions.
For more information about these features, see the reference manual.
Pause Prevention pacing – This feature monitors for prolonged pauses of programmed duration between
intrinsic ventricular events in OVO mode. If a pause is detected, the device switches to VVI pacing. After 30 s of VVI
pacing, the device switches back to OVO mode and resumes monitoring for prolonged pauses between intrinsic
ventricular events.
Post Shock pacing – This feature provides VVI pacing for 30 s following a defibrillation or cardioversion therapy.
1.8.6 Testing features
For more information about these features, see the reference manual.
Charge/Dump test – This feature tests the charge time of the capacitors and dumps any charge remaining on the
capacitors.
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EP Study tests – This set of protocols allows clinicians to induce arrhythmias and deliver on-demand
tachyarrhythmia therapies during electrophysiology studies. The available protocols are T-Shock, Burst Induction,
Programmed Electrical Stimulation (PES), Defibrillation, Cardioversion, and Burst ATP.
Lead Impedance Test – This feature tests the integrity of the implanted lead system by measuring the impedance
of the pacing and high-voltage electrodes. The test uses low-voltage, subthreshold pulses to make these
measurements.
Pacing Threshold test – This feature allows the clinician to determine the patient’s pacing stimulation thresholds.
This information can be used to determine appropriate amplitude, pulse width, and temperature sensitivity settings
that ensure capture and minimize output.
Sensing test – This feature measures R-wave amplitudes to help the clinician assess lead integrity and sensing
performance.
Wavelet Test – This feature evaluates the accuracy of the current wavelet template and allows the clinician to
collect a new template, if necessary.
1.8.7 Additional operations
MRI SureScan – This feature allows patients to be scanned safely by an MRI machine when used according to
the specified MRI conditions for use. Refer to the MRI technical manual for additional information.
1.9 Data security
Medtronic has designed safeguards to protect patient information and device data for the EV ICD model DVEX3E4
device.
Inductive telemetry communication system – The Medtronic inductive telemetry communication system is
used with the clinician programmer to interrogate and program the device through a programming head. This
system uses short-range communication that protects patient information and device data.
Long range wireless telemetry communication system – The Medtronic long range wireless telemetry
communication system is used with the clinician programmer to interrogate and program the device. This system
uses RF telemetry for wireless communications between the device and the programmer. During a wireless
telemetry session, all other programmers are locked out from communications with the patient’s implanted device
to protect patient information and device data.
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2 Warnings, precautions, and potential adverse events
2.1 General warnings and precautions
Refer to the Medical Procedure and EMI 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.
Avoiding shock during handling – Disable tachyarrhythmia detection during implant, explant, or postmortem
procedures. The device can deliver a high-voltage shock if the defibrillation terminals are touched.
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 during
acute lead system testing, the implant procedure, or whenever arrhythmias are possible or intentionally induced
during 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.
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Prior sternotomy – Use of the EV ICD model DVEX3E4 device has not been evaluated in patients who have
undergone a prior sternotomy.
2.2 Explant and disposal
Consider the following information related to device explant and disposal:
●
To prevent the device from delivering unwanted shocks, interrogate the device, then disable tachyarrhythmia
detection and Pause Prevention detection and therapy before explanting, cleaning, or shipping the device.
●
Explant the implanted device postmortem. In some countries, explanting battery-operated implanted devices
is mandatory because of environmental concerns; check the local regulations. In addition, the device can
explode if subjected to incineration or cremation temperatures.
●
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: Observe all local laws and regulations regarding the disposal of explanted devices or leads.
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.
Damaged package – The device packaging consists of an outer tray and an inner tray. Do not use the device or
accessories if the outer packaging tray is wet, punctured, opened, or damaged. Return the device to Medtronic
because the integrity of the sterile packaging or the device functionality may be compromised. This device is not
intended to be resterilized.
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). Electrical
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).
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2.4 Lead evaluation and lead connection
Refer to the lead technical manuals for specific instructions and precautions about lead handling.
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 torque wrench) have torque capabilities greater than the lead connector can tolerate.
Lead connection – Consider the following when connecting the lead to the device:
●
Cap abandoned leads to avoid transmitting electrical signals.
●
Verify lead connections. Loose lead connections may result in inappropriate sensing and failure to deliver
arrhythmia therapy.
Lead Impedance – Consider the following information about lead impedance when evaluating the lead system:
●
Ensure that the defibrillation lead impedance is greater than 30 Ω. An impedance of less than 30 Ω may
damage the device or prevent delivery of high-voltage therapy.
●
The impedance range for therapies delivered at ≤ 8 V is 100 - 1500 Ω.
●
The impedance range for therapies delivered at ≥ 10 V is 30 - 250 Ω.
●
Prior to taking electrical or defibrillation efficacy measurements, move objects made from conductive
materials, such as guide wires, away from all electrodes. Metal objects, such as guide wires, can short a lead
and an active implantable device, causing electrical current to bypass the heart and possibly damage the
implantable device and lead.
2.5 Device operation
Accessories – Use this device only with accessories, parts subject to wear, and disposable items that have been
tested to technical standards and found safe by an approved testing agency.
Battery depletion – Carefully monitor device longevity by checking battery voltage and replacement indicators.
Battery depletion eventually causes the device to stop functioning. Cardioversion and defibrillation are
high-energy therapies that shorten device longevity. An excessive number of charging cycles or treated Pause
Prevention episodes also shorten device longevity.
Charge Circuit Timeout or Charge Circuit Inactive message – Contact a Medtronic representative and
replace the device immediately if the programmer displays a Charge Circuit Timeout or Charge Circuit Inactive
message. If this message is displayed, high-voltage therapies are not available for the patient.
Concomitant devices – If a single-chamber bipolar pacemaker is used concomitantly with the Model DVEX3E4
device, verify that the concomitant device accurately senses and paces the patient’s heart:
●
Verify that the concomitant device correctly senses all intrinsic ventricular rhythms, including normal sinus
rhythm and all ventricular tachyarrhythmias.
●
Verify that the concomitant device maintains pacing capture.
If the concomitant device does not correctly sense and pace the patient’s heart, it can interfere with the normal
operation of the Model DVEX3E4 device. This interference can lead to inappropriate tachyarrhythmia detection
and therapy, or it can lead to undersensing of VF.
Note: The concomitant devices for which the Model DVEX3E4 device is contraindicated can be found in
Section 1.5, “Contraindications”, page 6.
Device status indicators – If any of the device status indicators (for example, Electrical Reset) are displayed on
the programmer after interrogating the device, inform a Medtronic representative immediately. If these device
status indicators are displayed, therapies may not be available to the patient.
Electrical reset – Electrical reset can be caused by exposure to temperatures below –18°C (0°F) or strong
electromagnetic fields. Advise patients to avoid strong electromagnetic fields. Observe temperature storage limits
to avoid exposure of the device to cold temperatures. If a full reset occurs, the device operates in OVO mode.
Electrical reset is indicated by a programmer warning message that is displayed immediately upon interrogation.
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To restore the device to its previous operation, it must be reprogrammed. Inform a Medtronic representative if your
patient’s device has reset.
Emergency VVI button disabled – The red, mechanical Emergency VVI button on the Medtronic models 2090
and Encore programmers is disabled during programmer sessions with the EV ICD model DVEX3E4 device. If
emergency therapy is needed during a programmer session, tap Emergency at the bottom of the programmer
screen. That screen button opens the Emergency window from where you can deliver either defibrillation or
cardioversion therapy to the patient.
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.
Follow-up testing – Consider the following information when performing follow-up testing of the device:
●
Keep external defibrillation equipment nearby for immediate use. Potentially harmful spontaneous or induced
tachyarrhythmias may occur during device testing.
●
Changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold
(DFT), preventing the device from terminating the patient’s tachyarrhythmias postoperatively. Successful
termination of ventricular fibrillation or ventricular tachycardia during the implant procedure is no assurance
that tachyarrhythmias can be terminated postoperatively.
Higher than programmed energy – The device may deliver a therapy of higher than programmed energy if it was
previously charged to a higher energy and that charge remains on the capacitors.
Magnets – Positioning a magnet over the device suspends tachyarrhythmia detection. If you place a programming
head over the device during a wireless telemetry session, the magnet in the programming head always suspends
tachyarrhythmia detection. If you place a programming head over the device and establish a nonwireless telemetry
session, tachyarrhythmia detection is not suspended.
Pacing and sensing safety margins – Lead maturation 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.
Patient safety during a wireless telemetry session – Make sure that you have selected the appropriate patient
before proceeding with a wireless patient session. Maintain visual contact with the patient for the duration of the
session. If you select the wrong patient and continue with the session, you may inadvertently program the patient’s
device to the wrong settings.
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.
Sensing settings – If you change any sensing parameters, verify that the new settings provide adequate safety
margins for the patient.
Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before changing the sensitivity
threshold to its minimum (most sensitive) setting of 0.075 mV.
Shipping values – Do not use shipping values or nominal values for pacing amplitude and sensing settings
without verifying that the values provide adequate safety margins for the patient.
2.6 Warnings, precautions, and guidance for clinicians performing medical procedures on cardiac device patients
This section is for health care professionals who perform medical procedures, in consultation with cardiologists,
on patients who have a Medtronic EV ICD Model DVEX3E4 single chamber, extravascular implantable
cardioverter defibrillator (ICD) system. The procedures in this section come with specific warnings, precautions,
and guidance. Failure to follow medical procedure warnings, precautions, and guidance can interfere with or
damage the implanted device system, or can lead to serious patient injury.
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For guidance on medical procedures that are not addressed in this section, health care professionals can contact
the following resources:
●
Health care professionals within the United States can contact Medtronic Technical Services
at +1 800 723 4636. You can also submit questions to tshelp@medtronic.com or to your Medtronic
representative.
●
Health care professionals outside of the United States can contact a Medtronic representative.
Ablation (RF ablation or microwave ablation) – Ablation is a surgical technique in which radiofrequency (RF)
or microwave energy is used to destroy cells by creating heat. Ablation used in cardiac device patients may result
in, but is not limited to, induced ventricular tachyarrhythmias, oversensing, unintended tissue damage, device
damage, or device malfunction. Pulse-modulated ablation systems may pose higher risk for induced ventricular
tachyarrhythmias. Medtronic cardiac devices are designed to withstand exposure to ablation energy. To mitigate
risks, observe the following precautions:
●
Ensure that temporary pacing and defibrillation equipment is available.
●
Avoid direct contact between the ablation catheter and the implanted system.
●
Position the return electrode patch so that the electrical current pathway does not pass through or near the
device and lead system.
●
Always monitor the patient during ablation with at least two separate methods, such as arterial pressure
display, ECG, manual monitoring of the patient’s rhythm (taking pulse) or monitor by some other means such
as ear or finger pulse oximetry, or Doppler pulse detection.
To avoid or mitigate the effects of oversensing, suspend tachyarrhythmia detection by using a magnet or a
programmer. If a programmer is used and ablation causes a device reset, the cardiac device resumes detection.
After the ablation procedure, remove the magnet or restore device parameters.
Dental procedures – Dental equipment, such as ultrasonic scalers, drills, and pulp testers, poses no risk of
electromagnetic interference. Keep a cardiac device at least 15 cm (6 in) away from magnets, such as magnets
found in dental office pillow headrests.
Diagnostic radiology (CT scans, fluoroscopy, mammograms, x-rays) – Diagnostic radiology refers to the
following medical procedures:
●
Computerized axial tomography (CT or CAT scan)
●
Fluoroscopy (an x-ray procedure that makes it possible to see internal organs in motion by producing a video
image)
●
Mammograms
●
X-rays (radiography, such as chest x-rays)
Normally, the accumulated dose from diagnostic radiology is not sufficient to damage the device. If the device is
not directly exposed to the radiation beam, no risk of interference with device operation occurs. However, if the
device is directly in a CT scan beam, see the following precautions in “CT scan”. Similar interference may be
observed for some forms of high-intensity fluoroscopy.
CT scan – A CT scan is a computerized process in which two-dimensional x-ray images are used to create a
three-dimensional x-ray image. If the device is not directly in the CT scan beam, the device is not affected. If the
device is directly in the CT scan beam, oversensing may occur for the duration of time the device is in the beam.
If the device will be in the beam for longer than 4 s, to avoid or mitigate the effects of oversensing, suspend
tachyarrhythmia detection by using a magnet or a programmer. After completing the CT scan, remove the magnet
or restore device parameters.
Diagnostic ultrasound – Diagnostic ultrasound is an imaging technique that is used to visualize muscles and
internal organs, their size, structures, and motion as well as any pathological lesions. It also is used for fetal
monitoring and to detect and measure blood flow. Diagnostic ultrasound, such as echocardiogram, poses no risk
of electromagnetic interference. For precautions about therapeutic ultrasound, see “Diathermy treatment
(including therapeutic ultrasound)”.
Diathermy treatment (including therapeutic ultrasound) – Diathermy is a treatment that involves the
therapeutic heating of body tissues. Diathermy treatments include high frequency, short wave, microwave, and
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therapeutic ultrasound. Except for therapeutic ultrasound, do not use diathermy treatments on cardiac device
patients. Diathermy treatments may result in serious injury or damage to an implanted device and lead system.
Therapeutic ultrasound (including physiotherapy, high intensity therapeutic ultrasound, and high intensity focused
ultrasound), is the use of ultrasound at higher energies than diagnostic ultrasound to bring heat or agitation into the
body. Therapeutic ultrasound is acceptable if treatment is performed with a minimum separation distance of 15 cm
(6 in) between the applicator and the implanted device and lead system, as long as the ultrasonic beam is pointing
away from the device and lead system.
Electrolysis – Electrolysis is the permanent removal of hair by using an electrified needle (AC or DC) that is
inserted into the hair follicle. Electrolysis introduces electrical current into the body, which may cause oversensing.
Evaluate any possible risks associated with oversensing with the patient’s medical condition. To avoid or mitigate
the effects of oversensing, suspend tachyarrhythmia detection by using a magnet or a programmer. After
completing electrolysis, remove the magnet or restore device parameters.
Electrosurgery – Electrosurgery (including electrocautery, electrosurgical cautery, Medtronic Advanced Energy
surgical incision technology, and hyfrecator) is a process in which an electric probe is used to control bleeding, to
cut tissue, or to remove unwanted tissue. Electrosurgery used on cardiac device patients may result in, but is not
limited to, oversensing, unintended tissue damage, tachyarrhythmias, device damage, or device malfunction. If
electrosurgery cannot be avoided, consider the following precautions:
●
Ensure that temporary pacing and defibrillation equipment is available.
●
Use a bipolar electrosurgery system or Medtronic Advanced Energy surgical incision technology, if possible.
If a unipolar electrosurgery system is used, position the return electrode patch so that the electrical current
pathway does not pass through or within 15 cm (6 in) of the device and lead system.
●
Do not apply unipolar electrosurgery within 15 cm (6 in) of the device and lead system.
●
Use short, intermittent, and irregular bursts at the lowest clinically appropriate energy levels.
●
Always monitor the patient during electrosurgery. If the ECG tracing is not clear due to interference, manually
monitor the patient’s rhythm (take pulse); alternatively, monitor by some other means such as ear or finger
pulse oximetry, Doppler pulse detection, or arterial pressure display.
To avoid or mitigate the effects of oversensing, suspend tachyarrhythmia detection by using a magnet or a
programmer. If a programmer is used and electrosurgery causes a device reset, the cardiac device resumes
detection. After completing electrosurgery, remove the magnet or restore device parameters.
External defibrillation and cardioversion – External defibrillation and cardioversion are therapies that deliver
an electrical shock to the heart to convert an abnormal heart rhythm to a normal rhythm.
The EV ICD Model DVEX3E4 is designed to withstand exposure to external defibrillation and cardioversion. While
damage to an implanted system from an external shock is rare, the probability increases with increased energy
levels. These procedures can also temporarily or permanently elevate pacing thresholds or temporarily or
permanently damage the myocardium. If external defibrillation or cardioversion are required, consider the
following precautions:
●
Use the lowest clinically appropriate energy.
●
The EV ICD Model DVEX3E4 device is implanted in the left midaxillary region. Do not position the patches or
paddles directly over the implanted device or lead.
●
Do not position the patches or paddles closer than 15 cm (6 in) to the device.
●
Position the patches or paddles perpendicular to the device and lead system.
●
If an external defibrillation or cardioversion is delivered within 15 cm (6 in) of the device, use a Medtronic
programmer to evaluate the device and lead system.
Hyperbaric therapy (including hyperbaric oxygen therapy, or HBOT) – Hyperbaric therapy is the medical use
of air or 100% oxygen at a higher pressure than atmospheric pressure. Hyperbaric therapies with pressures
exceeding 4.0 ATA, approximately 30 m (100 ft) of seawater, may affect device function or cause device damage.
To avoid or mitigate risks, do not expose implanted devices to pressures exceeding 4.0 ATA.
Lithotripsy – Lithotripsy is a medical procedure that uses mechanical shock waves to break up kidney or
gallbladder stones. If the device is at the focal point of the lithotripter beam, lithotripsy may permanently damage
the device. If lithotripsy is required, keep the focal point of the lithotripter beam a minimum distance of 2.5 cm (1 in)
away from the device. To avoid or mitigate the effects of oversensing, suspend tachyarrhythmia detection by using
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