Medtronic REVDD01 Implant Manual
RELIA™ REVDD01
Dual chamber pacemaker (VDD)
Implant 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.
Capture Management, EnPulse, Intrinsic, Kappa, Medtronic, Relia, Search AV, TherapyGuide
Contents
1 System overview 4
2 Indications 4
3 Contraindications 5
4 Warnings, precautions, and potential adverse events 5
4.1 Warnings and precautions to ensure intended device function 5
4.2 Potential adverse events 7
5 Patient selection and treatment 8
5.1 Select the pacing mode 8
5.2 Patient counseling information 9
5.3 Patient manual 9
5.4 Patient ID card 9
6 Clinical studies 9
6.1 Adverse events and clinical trial data 9
7 Implant procedure 9
7.1 Verify sufficient device longevity 10
7.2 Verify lead and connector compatibility 10
7.3 Test the lead system 11
7.4 Connect the leads to the device 11
7.5 Test the device operation 12
7.6 Position and secure the device 13
7.7 Program the device 13
7.8 Replace a device 13
8 Potential complications and emergency pacing 14
8.1 Potential complications 14
8.2 Emergency pacing 15
9 Magnet mode operation and Recommended Replacement Time (RRT/ERI)
indicators 15
9.1 Magnet mode operation 15
9.2 Recommended Replacement Time (RRT/ERI) indicators 16
10 Device parameters 16
10.1 Shipping, nominal, and electrical reset parameters 16
10.2 Programmable parameters 20
10.3 Automatic and clinician-selectable diagnostics 24
11 Device information 25
11.1 Physical characteristics 25
11.2 Electrical specifications 27
11.3 Projected service life 28
11.4 Prolonged service period 28
11.5 Feature summary 29
3
1 System overview
About this manual – This document is primarily an implant manual. Regular patient follow-up sessions should be
scheduled after implant. Follow-up procedures such as monitoring battery measurements and confirming therapy
parameters are described in the product documentation that is included with the software that supports this device.
To obtain additional copies of product documentation, contact a Medtronic representative.
This manual describes the Medtronic Relia VDD dual chamber, multiprogrammable, implantable pulse generator
(IPG) bipolar/unipolar Model REVDD01. This device is also referred to as a pacemaker.
Single chamber rate response – Single chamber rate response is controlled through an activity-based sensor.
Programmer and software – Use the appropriate Medtronic programmer and software to program this device.
Programmers from other manufacturers are not compatible with Medtronic devices but will not damage Medtronic
devices.
Contents of sterile package – The package contains 1 implantable pulse generator and 1 torque wrench used
to tighten setscrews.
Additional manuals and documents with information about the device:
Programming guide – This manual contains device programming procedures and patient follow-up guidelines.
The programming guide applies to multiple models within a device family.
Reference guide – This manual contains feature descriptions, troubleshooting information, and other device
reference information. The reference manual applies to multiple models within a device family.
Radio regulatory compliance information – This document provides compliance information related to the
radio components of the device.
Explanation of symbols – This document defines the symbols that may appear on the device package. Refer to
the package label to see which symbols apply specifically to this device.
Medical Procedure and EMI Warnings and Precautions Manual for Health Care Professionals – This
manual provides warnings, precautions, and guidance for health care professionals who perform medical
therapies and diagnostic procedures on cardiac device patients. The manual also provides patient education
information related to sources of electromagnetic interference (EMI) at home, at work, and in other environments.
2 Indications
Medtronic Relia VDD Series implantable pulse generators (IPGs) are indicated for use in patients who have
experienced one or more of the following conditions:
●
symptomatic paroxysmal or permanent second- or third-degree AV block
●
symptomatic bilateral bundle branch block
These devices are also indicated for use in patients who may benefit from maintenance of AV synchrony through
the use of dual chamber modes and atrial tracking modes. Dual chamber modes are specifically indicated for
treatment of conduction disorders that require restoration of both rate and AV synchrony. Dual chamber modes are
indicated for use in patients who have experienced one or both of the following conditions:
●
various degrees of AV block
●
VVI intolerance (for example, pacemaker syndrome) in the presence of a persistent sinus rhythm
These devices are indicated for VDD pacing in patients who have adequate rates and one or both of the following
conditions:
●
A requirement for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes
are present. This includes the presence of complete AV block when atrial contribution is needed for
hemodynamic benefit or when pacemaker syndrome has existed or is anticipated.
●
A requirement for intermittent ventricular pacing despite a normal sinus rhythm and normal AV conduction.
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3 Contraindications
Medtronic Relia VDD Series implantable pulse generators (IPGs) are contraindicated for the following
applications:
●
Asynchronous pacing in the presence (or likelihood) of competition between paced and intrinsic rhythms
●
Use of an implantable cardioverter defibrillator (ICD) with a unipolar-only IPG or in those cases in which
unipolar leads are implanted with the IPG. Pacing in the unipolar configuration may cause the ICD to deliver
inappropriate therapy or to withhold appropriate therapy.
4 Warnings, precautions, and potential adverse events
4.1 Warnings and precautions to ensure intended device function
4.1.1 Device operation
Accessories – Use this device only with accessories, parts subject to wear, and disposable items that have been
tested to technical standards and found safe by an approved testing agency.
Device status indicators – If any of the device status indicators (for example, Electrical Reset) are displayed on
the programmer after interrogating the device, inform a Medtronic representative immediately. If these device
status indicators are displayed, therapies may not be available to the patient.
Effects of myopotential sensing in unipolar sensing configurations – In unipolar sensing configurations, the
device may not distinguish myopotentials from cardiac signals. This may result in a loss of pacing due to inhibition.
Also, unipolar atrial sensing in atrial tracking modes can result in elevated ventricular pacing rates. To address
these situations, the device may be programmed to be less sensitive (using higher sensitivity values). However,
the sensitivity level must be balanced against the potential to undersense true cardiac signals. Typically, this
balance is easily attained for ventricular sensing using sensitivity values around 2.8 mV, but it may be difficult to
attain for atrial sensing because of the smaller P-wave amplitudes.
Electrical isolation during implant – Do not allow the patient to have contact with grounded electrical equipment
that might produce electrical current leakage during implant. Electrical current leakage may induce
tachyarrhythmias that may result in the patient’s death.
Electrical reset – Electrical reset can be caused by exposure to temperatures below –18°C (0°F) or strong
electromagnetic fields. Advise patients to avoid strong electromagnetic fields. Observe temperature storage limits
to avoid exposure of the device to cold temperatures. If a partial reset occurs, pacing resumes in the programmed
mode with many of the programmed settings retained. If a full reset occurs, the device operates in VVI mode at
65 ppm. Electrical reset is indicated by a programmer warning message that is displayed immediately upon
interrogation. To restore the device to its previous operation, it must be reprogrammed.
See Section 10.1, “Shipping, nominal, and electrical reset parameters”, page 16 for a complete list of preserved
and changed partial and full reset parameters.
Epicardial leads – Epicardial leads have not been determined appropriate for use with the Ventricular Capture
Management feature. Program Ventricular Capture Management to Off if implanting an epicardial lead.
Hex wrench – Do not use a blue-handled or right-angled hex wrench. These wrenches have torque capabilities
greater than the lead connector can tolerate. The setscrews may be damaged by excessive torque.
Lead compatibility – 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.
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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Muscle stimulation – Muscle stimulation (for example, due to high-output unipolar pacing) may result in pacing
at rates up to the Upper Sensor rate in rate responsive modes.
Pacing and sensing safety margins – Consider lead maturation when selecting pacing amplitudes, pacing
pulse widths, and sensing levels. Loss of capture may occur if lead maturation is not considered when selecting
settings.
PMT intervention – Even with the feature turned to On, PMTs may still require clinical intervention such as
pacemaker reprogramming, magnet application, drug therapy, or lead evaluation.
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-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.
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.
Slow retrograde conduction – Slow retrograde conduction may induce pacemaker-mediated tachycardia
(PMT) when the VA conduction time is greater than 400 ms. Programming PMT intervention may help prevent PMT
when the VA conduction time is less than 400 ms.
Tip contacts – When implanting a device, ensure that the tip setscrews are properly engaged and all electrical
contacts are sealed to prevent possible electrical leakage. Also, ensure that electrical contacts are sealed when
using lead extenders or adaptors with bipolar models. Electrical leakage may cause a loss of output.
Twiddler’s syndrome – Twiddler’s syndrome, i.e., patient manipulation of the device after implant, may cause the
pacing rate to increase temporarily if the pacemaker is programmed to a rate responsive mode.
Ventricular Capture Management – Ventricular Capture Management does not program ventricular outputs
above 5.0 V or 1.0 ms. If the patient needs a pacing output higher than 5.0 V or 1.0 ms, manually program Amplitude
and Pulse Width. If a lead dislodges partially or completely, Ventricular Capture Management may not prevent
loss-of-capture.
4.1.2 Device system warnings and precautions for pacemaker-dependent patients
Asynchronous pacing mode – The VOO asynchronous pacing mode disables sensing. It is not appropriate to
permanently program this pacing mode for pacemaker-dependent patients.
Diagnostic modes – Do not program diagnostic modes (ODO, OVO, and OAO) for pacemaker-dependent
patients. Instead, use the programmer’s inhibit function for brief interruption of outputs.
Inhibit function – Use caution when using the programmer to inhibit pacing. The patient is without pacing support
when pacing is inhibited.
Polarity override – Do not override the polarity verification prompt with bipolar polarity when a unipolar lead is
connected. Overriding the polarity verification prompt results in no pacing output.
Threshold Margin Test (TMT) and loss of capture – Be aware that loss of capture during a TMT at a 20%
reduction in amplitude indicates an inadequate stimulation safety margin.
4.1.3 External devices during implant
External defibrillation equipment – Keep external defibrillation equipment nearby for immediate use whenever
arrhythmias are possible or intentionally induced during device testing, implant procedures, or post-implant
testing.
External pacing instrument – Keep an external pacing instrument available for immediate use. When the lead
is disconnected, pacemaker-dependent patients are without pacing support.
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4.1.4 Handling and storage instructions
Follow these guidelines when handling or storing the device.
Device storage – Store the device in a clean area, away from magnets, kits containing magnets, and sources of
electromagnetic interference. Exposing the device to magnets or electromagnetic interference may damage the
device.
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).
Use by date – Do not implant the device after the “Use by” date on the package label. Battery longevity may be
reduced.
Checking and opening the package – Before opening the sterile package tray, visually check for any signs of
damage that might invalidate the sterility of the package contents.
If the package is damaged – The device packaging consists of an outer tray and inner tray. Do not use the device
or accessories if the outer packaging tray is wet, punctured, opened, or damaged. Return the device to Medtronic
because the integrity of the sterile packaging or the device functionality may be compromised. This device is not
intended to be resterilized.
If the package information is damaged – If any information on the outer package or the sterile package is
defaced or damaged so that you cannot read it, notify a Medtronic representative so that the device can be
replaced.
If the printed manual is illegible – If this manual is supplied in its printed form and any part of it is illegible, contact
a Medtronic representative to request a replacement manual.
Dropped device – Do not implant the device if it is dropped on a hard surface from a height of 30 cm (12 in) or more
after it is removed from its packaging.
Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. This device is
for single use only and is not intended to be resterilized.
For single use only – Do not resterilize and reimplant an explanted device that has been contaminated by contact
with body fluids.
Device temperature – Allow the device to reach room temperature before it is programmed or implanted. Device
temperature above or below room temperature may affect initial device function.
4.1.5 Explant and disposal
Consider the following information related to device explant and disposal:
●
Explant the implantable device postmortem. In some countries, explanting battery-operated implantable
devices is mandatory because of environmental concerns; please check the local regulations. In addition, if
subjected to incineration or cremation temperatures, the device may explode.
●
Medtronic implantable devices are intended for single use only. Do not resterilize and reimplant explanted
devices.
●
Contact Medtronic for Return Mailer Kits to return explanted devices for analysis and disposal. See the back
cover for addresses. Note: Disposal of explanted devices or leads is subject to local, state, and federal
regulations.
4.2 Potential adverse events
Potential adverse events associated with the use of a device system (defined as the device and leads) include, but
are not limited to, the following:
●
Air embolism
●
Allergic reaction
●
Bleeding
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Body rejection phenomena including local tissue rejection
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Cardiac dissection
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Cardiac perforation
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Cardiac tamponade
●
Chronic nerve damage
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Death
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Embolism
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Endocarditis
●
Erosion of the device and lead through the skin
●
Excessive fibrosis
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Extrusion
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Fibrillation or other arrhythmias
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Fluid accumulation
●
Formation of cysts
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Heart block
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Heart wall rupture
●
Hematoma/seroma
●
Inappropriate acceleration of arrhythmias
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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
●
Transvenous lead-related thrombosis
●
Valve damage (particularly in fragile hearts)
●
Venous occlusion
●
Venous perforation
●
Vein wall rupture
5 Patient selection and treatment
5.1 Select the pacing mode
TherapyGuide offers a simple clinically-focused method for a clinician to obtain suggested parameter values. At
implant or an early follow-up appointment, the clinician enters information about the patient’s clinical conditions.
Based on those inputs the programmer suggests parameter settings. The suggestions are based on clinical
studies, literature, current practice, and the consensus of physicians.
TherapyGuide suggests a programmable mode based on clinical conditions such as the condition of the sinus
node and the quality of AV conduction.
TherapyGuide offers a Rationale screen that shows the basis for each setting of pacing modes and of other
parameters. To access the screen, perform the following steps:
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1. Interrogate the pacemaker following implant.
2. Select the Params icon. On the Therapy Parameters screen, select the [TherapyGuide] button to open the
TherapyGuide window.
3. Select the [Rationale…] button to open the Rationale window.
4. Select [Close] twice to return to the Therapy Parameters screen.
Note: Refer to the Pacemaker Programming Guide for instructions on programming parameters using
TherapyGuide.
5.2 Patient counseling information
The clinician may wish to discuss the following topics with the patient before discharge:
●
Review the signs and symptoms that should be reported to the patient’s physician.
●
Review instructions to the patient concerning physical activity.
●
Advise the patient on the frequency of follow-up care.
●
Inform the patient of cautions regarding sources of electromagnetic interference (EMI).
●
Educate the patient about the consequences of device manipulation (Twiddler’s syndrome).
5.3 Patient manual
A patient manual is packaged with the device. The patient manual contains information for the patient, the patient’s
family, and other interested people. Discuss the information in this manual with concerned individuals so they are
familiar with the operation of the device. To obtain additional copies of the patient manual, contact a Medtronic
representative, or call the toll-free phone number on the back cover of the patient manual.
5.4 Patient ID card
A temporary patient ID card is packaged with each device. A permanent patient ID card is mailed to the patient
within a month after Medtronic receives the Device Registration Form. Advise the patient to always carry the
patient ID card.
6 Clinical studies
6.1 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:
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.
7 Implant procedure
Proper surgical procedures and sterile techniques are the responsibility of the physician. The following procedures
are provided for information only. Each physician must apply the information in these procedures according to
professional medical training and experience.
The implant procedure includes the following steps:
●
Verify sufficient device longevity.
●
Verify lead and connector compatibility.
9
●
Test the lead system.
●
Connect the leads to the device.
●
Test the device operation.
●
Position and secure the device.
●
Program the device.
●
Replace a device.
7.1 Verify sufficient device longevity
Complete the following steps prior to opening the pacemaker box:
1. Check the use-by date printed on the package.
2. Place the programmer head over the box and start the application.
3. Interrogate the device.
4. Confirm the battery voltage is at least 2.75 V at room temperature using the Programming Guide instructions
for viewing battery status.
5. Contact your Medtronic representative if the use-by date or battery voltage is out of range.
7.2 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, result in electrical current leakage, or result in an intermittent electrical connection.
Select a compatible lead. Refer to the following table.
Table 1. Lead and connector compatibility
Connector Polarity Compatibility
Ventricular Bipolar/Unipolar Compatible with the IS-1 standard for unipolar and
bipolar pacing and sensing
a
Atrial Bipolar Compatible with the mechanical requirements of the
IS-1 standard, but is only designed for sensing
a
IS-1 refers to the International Connector Standard (see Document No. ISO 5841-3) whereby pulse generators
a
and leads so designated are assured of meeting the electrical and mechanical parameters specified in the IS-1
International Standard.
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