Medtronic D314DRG User Manual
PROTECTA™ XT DR D314DRG
Digital dual chamber implantable cardioverter defibrillator
(DDE-DDDR)
SmartShock™ Technology (RV Lead Noise Discrimination, RV
Lead Integrity Alert, TWave Discrimination, Confirmation+,
Wavelet, PR Logic®), OptiVol® 2.0 Fluid Status Monitoring,
Complete Capture Management™ Diagnostic (ACM, RVCM),
ATP During Charging™ Feature, and MVP® Mode
Clinician Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PROTECTA™ XT DR D314DRG
Clinician Manual
A guide to the operation and programming of the Model D314DRG Protecta XT DR digital dual
chamber implantable cardioverter defibrillator (DDE-DDDR)
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.
ATP During Charging, Active Can, Capture Management, Cardiac Compass,
CardioSight, CareAlert, CareLink, ChargeSaver, Checklist, Conexus, EnPulse,
EnRhythm, EnTrust, Flashback, GEM, GEM DR, GEM III, InCheck, InSync,
InSync III Marquis, InSync Marquis, Intrinsic, Jewel, Kappa, MVP, Marker Channel,
Marquis, Medtronic, Medtronic AT500, Medtronic CareAlert, Medtronic CareLink,
OptiVol, PR Logic, Paceart, Protecta, Quick Look, Reactive ATP, SessionSync,
SmartShock, Sprint Fidelis, SureScan, Switchback, T-Shock, TherapyGuide
Medtronic PROTECTA™ XT DR D314DRG
Contents
1 System overview .................................................... 10
1.1 Introduction ........................................................ 10
1.2 System description .................................................. 19
1.3 Indications and usage ............................................... 22
1.4 Contraindications ................................................... 22
2 Warnings, precautions, and potential adverse events .................. 23
2.1 General warnings and precautions .................................... 23
2.2 Explant and disposal ................................................ 23
2.3 Handling and storage instructions ..................................... 24
2.4 Lead evaluation and lead connection .................................. 25
2.5 Device operation .................................................... 25
2.6 Warnings, precautions, and guidance for clinicians performing medical
procedures on cardiac device patients ............................... 28
2.7 Warnings, precautions, and guidance related to electromagnetic
interference (EMI) for cardiac device patients ......................... 34
2.8 Potential adverse events ............................................. 38
3 Clinical data ......................................................... 41
3.1 Adverse events and clinical trial data .................................. 41
4 Using the programmer ............................................... 45
4.1 Establishing telemetry between the device and the programmer ........... 45
4.2 Conducting a patient session ......................................... 52
4.3 Display screen features .............................................. 57
4.4 Delivering an emergency tachyarrhythmia therapy ....................... 62
4.5 Enabling emergency VVI pacing ...................................... 63
4.6 Streamlining implant and follow-up sessions with Checklist ............... 65
4.7 Viewing and programming device parameters ........................... 70
4.8 Saving and retrieving a set of parameter values ......................... 75
4.9 Using TherapyGuide to select parameter values ......................... 76
4.10 Viewing and entering patient information ............................... 80
4.11 Working with the Live Rhythm Monitor ................................. 84
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Medtronic PROTECTA™ XT DR D314DRG
4.12 Expediting follow-up sessions with Leadless ECG ....................... 92
4.13 Saving and retrieving device data ..................................... 93
4.14 Using SessionSync to transfer device data to the Paceart system .......... 95
4.15 Printing reports .................................................... 102
5 Implanting the device ............................................... 109
5.1 Preparing for an implant ............................................ 109
5.2 Selecting and implanting the leads ................................... 111
5.3 Testing the lead system ............................................. 113
5.4 Connecting the leads to the device ................................... 115
5.5 Performing ventricular defibrillation threshold tests ...................... 117
5.6 Positioning and securing the device .................................. 120
5.7 Completing the implant procedure .................................... 121
5.8 Replacing a device ................................................. 123
6 Conducting a patient follow-up session .............................. 125
6.1 Patient follow-up guidelines ......................................... 125
6.2 Viewing a summary of recently stored data ............................ 129
6.3 Automatic alerts and notification of clinical management and system
performance events .............................................. 133
6.4 Monitoring leads using RV Lead Integrity Alert ......................... 141
6.5 Viewing long-term clinical trends with the Cardiac Compass Report ....... 148
6.6 Viewing heart failure management information ......................... 154
6.7 Monitoring for thoracic fluid accumulation with OptiVol .................. 161
6.8 Viewing Arrhythmia Episodes data and setting data collection
preferences ..................................................... 166
6.9 Viewing episode and therapy counters ................................ 175
6.10 Viewing Flashback Memory data ..................................... 180
6.11 Viewing Rate Drop Response episodes ............................... 181
6.12 Using rate histograms to assess heart rates ............................ 183
6.13 Viewing detailed device and lead performance data ..................... 186
6.14 Automatic device status monitoring ................................... 194
6.15 Optimizing device longevity ......................................... 197
7 Configuring pacing therapies ........................................ 201
7.1 Sensing intrinsic cardiac activity ...................................... 201
7.2 Providing pacing therapies .......................................... 212
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Medtronic PROTECTA™ XT DR D314DRG
7.3 Reducing unnecessary ventricular pacing with MVP mode ............... 223
7.4 Providing rate-responsive pacing ..................................... 230
7.5 Managing pacing output energies with Capture Management ............ 238
7.6 Adapting the AV interval during rate changes .......................... 251
7.7 Adjusting PVARP to changes in the patient’s heart rate .................. 253
7.8 Treating syncope with Rate Drop Response ........................... 256
7.9 Promoting the intrinsic rate during periods of inactivity ................... 262
7.10 Providing a slower pacing rate during periods of sleep ................... 264
7.11 Preventing competitive atrial pacing .................................. 266
7.12 Interrupting pacemaker-mediated tachycardias ........................ 268
7.13 Managing retrograde conduction using PVC Response .................. 269
7.14 Reducing inappropriate ventricular inhibition using VSP ................. 271
7.15 Preventing rapid ventricular pacing during atrial tachyarrhythmias ......... 273
7.16 Increasing the pacing output after a high-voltage therapy ................ 276
7.17 Using atrial intervention pacing to counteract atrial tachyarrhythmias ...... 277
7.18 Smoothing the ventricular rate during conducted AF .................... 287
7.19 Providing overdrive pacing after a VT/VF high-voltage therapy ............ 289
7.20 Responding to PVCs using Ventricular Rate Stabilization ................ 291
8 Configuring tachyarrhythmia detection .............................. 295
8.1 Detecting atrial tachyarrhythmias ..................................... 295
8.2 Detecting ventricular tachyarrhythmias ................................ 304
8.3 Discriminating VT/VF from SVT using PR Logic ........................ 321
8.4 Discriminating VT/VF from SVT using Wavelet ......................... 326
8.5 Discriminating sinus tachycardia from VT using the Onset feature ......... 334
8.6 Discriminating AT/AF from VT using the Stability feature ................. 340
8.7 Detecting prolonged tachyarrhythmias using High Rate Timeout .......... 342
8.8 Discriminating RV lead noise from VT/VF .............................. 345
8.9 Discriminating T-wave oversensing from VT/VF ........................ 350
8.10 Suspending and resuming tachyarrhythmia detection ................... 354
9 Configuring tachyarrhythmia therapies .............................. 356
9.1 Treating episodes detected as VF .................................... 356
9.2 Treating VT and FVT episodes with antitachycardia pacing therapies ...... 368
9.3 Treating VT and FVT with ventricular cardioversion ..................... 380
9.4 Scheduling atrial therapies .......................................... 389
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Medtronic PROTECTA™ XT DR D314DRG
9.5 Treating AT/AF episodes with antitachycardia pacing ................... 396
9.6 Treating AT/AF with atrial cardioversion ............................... 407
9.7 Providing patient-activated atrial cardioversion ......................... 414
9.8 Optimizing therapy with Progressive Episode Therapies ................. 418
9.9 Optimizing charge time with Automatic Capacitor Formation ............. 421
10 Testing the system ................................................. 425
10.1 Evaluating the underlying rhythm ..................................... 425
10.2 Measuring pacing thresholds ........................................ 425
10.3 Testing the Wavelet feature ......................................... 427
10.4 Measuring lead impedance .......................................... 432
10.5 Performing a Sensing Test .......................................... 432
10.6 Testing the device capacitors ........................................ 434
10.7 Inducing an arrhythmia ............................................. 436
10.8 Delivering a manual therapy ......................................... 444
A Quick reference .................................................... 447
A.1 Physical characteristics ............................................. 447
A.2 Replacement indicators ............................................. 448
A.3 Projected service life ............................................... 448
A.4 Energy levels and typical charge times ................................ 450
A.5 Magnet application ................................................. 451
A.6 Stored data and diagnostics ......................................... 451
B Device parameters ................................................. 459
B.1 Emergency settings ................................................ 459
B.2 Tachyarrhythmia detection parameters ................................ 459
B.3 Atrial tachyarrhythmia therapy parameters ............................. 461
B.4 Ventricular tachyarrhythmia therapy parameters ........................ 464
B.5 Pacing parameters ................................................. 466
B.6 Medtronic CareAlert parameters ..................................... 471
B.7 Data collection parameters .......................................... 474
B.8 System test parameters ............................................. 475
B.9 EP study parameters ............................................... 476
B.10 Nonprogrammable parameters ...................................... 479
Glossary ................................................................ 481
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Medtronic PROTECTA™ XT DR D314DRG
Index ................................................................... 488
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Medtronic PROTECTA™ XT DR D314DRG
1 System overview
1.1 Introduction
1.1.1 About this manual
This manual describes the operation and intended use of the Protecta XT DR Model
D314DRG system.
1.1.1.1 Manual conventions
Throughout this manual, the word “device” refers to the implanted Protecta XT DR device.
The symbol in parameter tables indicates the Medtronic nominal value for that parameter.
The programmer screen image examples in this manual were produced using a Medtronic
CareLink Model 2090 Programmer. These screen images are provided for reference only
and may not match the final software.
The names of on-screen buttons are shown within brackets: [Button Name].
Programming instructions in this manual are often represented by a programming block,
which describes the path through the application software to specific screens or parameters.
The following conventions are used in programming blocks:
●
The “⇒” symbol precedes the screen text you can select to navigate to a new screen.
●
The “▷” symbol precedes the name of a parameter you can program for a feature.
●
When a navigation step refers to a field on the screen that is labeled with both a row title
and a column title, the “ | ” character is used to divide the separate titles. Parameter
values, however, do not use this convention.
●
When a particular value for a parameter must be selected to make the remaining
parameters or navigation possible, that value appears within <brackets>.
Here is an example of a programming block using these conventions:
Select Params icon
⇒ Screen text to select…
⇒ Screen field Row Title | Column Title…
▷ Parameter Name <Required Value>
▷ Parameter Name
▷ Parameter Name
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Medtronic PROTECTA™ XT DR D314DRG
1.1.2 Product literature
Before implanting the device, it is strongly recommended that you take the following actions:
●
Read the product literature provided for information about prescribing, implanting, and
using the device, and for conducting a patient follow-up session.
●
Thoroughly read the technical manuals for the leads used with the device. Also read
the technical manuals for other system components.
●
Discuss the device and implant procedure with the patient and any other interested
parties, and provide them with any patient information materials packaged with the
device.
1.1.3 Technical support
Medtronic employs highly trained representatives and engineers located throughout the
world to serve you and, upon request, to provide training to qualified hospital personnel in
the use of Medtronic products.
In addition, Medtronic maintains a professional staff of consultants to provide technical
consultation to product users.
For more information, contact your local Medtronic representative, or call or write Medtronic
at the appropriate address or telephone number listed on the back cover.
1.1.4 Customer education
Medtronic invites physicians to attend an educational seminar on the device. The course
describes indications for use, system functions, implant procedures, and patient
management.
1.1.5 Explanation of symbols
The following list of symbols and abbreviations applies to various products. Refer to the
package labels to see which of these apply to this product.
Clinician Manual 11
Medtronic PROTECTA™ XT DR D314DRG
Table 1. Explanation of symbols on package labeling
Symbol Explanation
Conformité Européenne (European Conformity). This symbol means that
the device fully complies with AIMD Directive 90/385/EEC (NB 0123) and
R&TTE Directive 1999/5/EC.
This symbol means that the device fully complies with the Australian
Communications and Media Authority (ACMA) and the New Zealand Ministry of Economic Development Radio Spectrum Management standards
for radio communications products.
Radio compliance. This symbol means that telecommunications and
radio communications regulations in your country may apply to this product. Please go to www.medtronic.com/radio for specific compliance information related to telecommunications and radio standards for this product
in your country.
MR Conditional. The SureScan pacing system is safe for use in the MRI
environment when used according to the instructions in the SureScan
technical manual.
Note: Not all devices are MR Conditional.
Caution
Open here
Do not use if package is damaged
Do not reuse
Sterilized using ethylene oxide
Consult instructions for use
For US audiences only
Date of manufacture
Manufacturer
12 Clinician Manual
EC REP
Medtronic PROTECTA™ XT DR D314DRG
Table 1. Explanation of symbols on package labeling (continued)
Symbol Explanation
Authorized representative in the European community
Use by
Lot number
Reorder number
Serial number
Temperature limitation
Adaptive
Clinician Manual 13
Package contents
Implantable device
IPG device
Coated (IPG device)
ICD device
Coated (ICD device)
Medtronic PROTECTA™ XT DR D314DRG
Table 1. Explanation of symbols on package labeling (continued)
Symbol Explanation
Cardiac resynchronization therapy (CRT) device
Coated (CRT device)
Dual chamber IPG with cardiac resynchronization therapy (CRT-P)
Product documentation
Torque wrench
Accessories
Amplitude/pulse width
Atrial amplitude/pulse width
RV amplitude/pulse width
LV amplitude/pulse width
Upper tracking rate/lower rate
Rate
Lower rate
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Medtronic PROTECTA™ XT DR D314DRG
Table 1. Explanation of symbols on package labeling (continued)
Symbol Explanation
Sensitivity
Sensed A-V interval
A-V interval (paced/sensed)
Refractory period
Atrial refractory period
Ventricular refractory period
(PVARP) Post Ventricular Atrial Refractory Period
Polarity
Pacing polarity (single chamber)
Pacing polarity (dual chamber)
LV Pace polarity
Atrial Pace polarity
RV Pace polarity
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Medtronic PROTECTA™ XT DR D314DRG
Table 1. Explanation of symbols on package labeling (continued)
Symbol Explanation
Sensing polarity (single chamber)
Sensing polarity (dual chamber)
Atrial sensitivity
Ventricular sensitivity
VF therapies (delivered/stored)
VT therapies
V pacing/V-V pace delay
VT monitor
AT/AF detection
VT, VF detection
VT, FVT, VF detection
AT/AF therapies
VT, VF therapies
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Medtronic PROTECTA™ XT DR D314DRG
Table 1. Explanation of symbols on package labeling (continued)
Symbol Explanation
VT, FVT therapies (CRT)
AT/AF intervention
Burst
Burst (CRT)
Burst+
50 Hz Burst
A ramp
Ramp (CRT)
Ramp+
Ramp+ (CRT)
V ramp
AV ramp
Defibrillation
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Medtronic PROTECTA™ XT DR D314DRG
Table 1. Explanation of symbols on package labeling (continued)
Symbol Explanation
V cardioversion
AV cardioversion
FVT therapies
Mode Switch
Magnet Rate
Dangerous voltage
Active Can
TR Triple chamber rate responsive pacemaker
DR Dual chamber rate responsive pacemaker
D Dual chamber pacemaker
SR Single chamber rate responsive pacemaker
S Single chamber pacemaker
1.1.6 Notice
The Patient Information screen of the programmer software application is provided as an
informational tool for the end user. The user is responsible for accurate input of patient
information into the software. Medtronic makes no representation as to the accuracy or
completeness of the patient information that end users enter into the Patient Information
screen. Medtronic SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL,
OR CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH RESULT FROM THE
USE OF THE PATIENT INFORMATION SUPPLIED BY END USERS TO THE SOFTWARE.
For more information about the Patient Information screen, see Section 4.10.
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Medtronic PROTECTA™ XT DR D314DRG
1.2 System description
The Medtronic Model D314DRG Protecta XT DR dual chamber implantable cardioverter
defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the
patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing,
ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies.
The device senses the electrical activity of the patient’s heart using the electrodes of the
implanted atrial and right ventricular leads. It then analyzes the heart rhythm based on
selectable detection parameters.
The device can automatically detect ventricular tachyarrhythmias (VT/VF) and provides
treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The
device can also automatically detect atrial tachyarrhythmias (AT/AF) and provides
treatment with cardioversion and antitachycardia pacing therapies. The device responds to
bradyarrhythmias by providing bradycardia pacing therapy.
The device also provides diagnostic and monitoring information that assists with system
evaluation and patient care.
Leads – The lead system used with this device must provide sensing, pacing and
cardioversion/defibrillation therapies 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 leads for this device, refer to Section 5.2,
“Selecting and implanting the leads”, page 111.
Implantable device system – The Model D314DRG Protecta XT DR along with pacing
leads and defibrillation leads constitute the implantable portion of the device system. The
following figure shows the major components that communicate with the implantable device
system.
Clinician Manual 19
VVI
Medtronic CareLink Programmer and
Analyzer
Conexus Activator
Medtronic CareLink Monitor
Implantable device
system
InCheck Patient
Assistant
AF?
Clinic
Home
Medtronic PROTECTA™ XT DR D314DRG
Figure 1. System components
Programmers and software – The Medtronic CareLink Model 2090 Programmer and
software are used to program this device. The Medtronic CareLink Model 2090 Programmer
with Conexus wireless telemetry is designed to provide clinicians and patients with an easy
and efficient implant, follow-up, and monitoring experience. Conexus wireless telemetry
eliminates the need to have a programming head placed over the implanted device for the
duration of a programming or monitoring session. The system uses radio frequency (RF)
telemetry for wireless communication between the implanted device and programmer in the
hospital or clinic. Conexus telemetry operates within the Medical Implant Communications
Service (MICS) Band, which is the only band designated for implantable medical devices.
Using the MICS Band prevents interference with home electronics such as microwaves,
cell phones, and baby monitors.
To turn on Conexus telemetry in an implanted device, you must use the Conexus Activator
or the programming head. If you do not use the Conexus Activator or if you are using a
programmer with nonwireless telemetry, you will need to use the programming head to both
initiate and conduct communications with the device in the clinic.
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Medtronic PROTECTA™ XT DR D314DRG
During a wireless telemetry session, all other programmers are prevented from
communicating or initiating a session with the patient’s implanted device, maintaining
patient safety and privacy. Similarly, other patients with implanted devices are not affected
by any communication or programming occurring during the patient’s session.
Programmers from other manufacturers are not compatible with Medtronic devices but will
not damage Medtronic devices.
Model 27901 Conexus Activator – The Medtronic Model 27901 Conexus Activator allows
you to turn on Conexus wireless telemetry for implanted devices that support wireless
telemetry. The Conexus Activator is used in conjunction with the Medtronic CareLink Model
2090 Programmer with Conexus telemetry in the hospital or clinic.
Model 2290 Analyzer – The system supports the use of the Medtronic CareLink Model
2290 Analyzer, an accessory of the Medtronic CareLink programmer. The system allows
you to have a device session and an analyzer session running at the same time, to quickly
switch from one to the other without having to end or restart sessions, and to send data from
the analyzer to the programmer.
Model 2490C Medtronic CareLink Monitor – Patients use the Model 2490C monitor to
automatically gather information from their implanted device and communicate the
information to their physician. The monitor communicates wirelessly with the patient’s
device and transmits the information over a home telephone line at times scheduled by the
clinic. Typically, these transmissions are scheduled while the patient is asleep. The monitor
can also send Medtronic CareAlert Notifications to the clinic outside of the scheduled
transmission times, if the device has been programmed to do so. The patient does not need
to interact with the monitor other than performing the initial setup procedure. Refer to the
monitor literature for connection and usage information.
Model 2696 InCheck Patient Assistant – Patients can use the Model 2696 InCheck
Patient Assistant to perform the following tasks:
●
Initiate recording of cardiac event data in the device memory. Cardiac event data can
be viewed either on the programmer or using CareLink. In addition, when the InCheck
Patient Assistant is activated, the EGM signals of the programmed EGM sources and
markers are stored in the device and are available for review using CareLink. The
CareLink monitor transmits the EGM data and markers from the patient’s device to the
CareLink Network. You can identify patients who have new, not previously viewed
patient-activated episodes and then proceed to view their EGM data using the Detailed
EGM Viewer on CareLink.
●
Verify whether the implanted device has detected a suspected atrial tachyarrhythmia.
●
Request delivery of atrial cardioversion therapy (if the device is programmed to allow
patient-activated cardioversion).
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Medtronic PROTECTA™ XT DR D314DRG
Note: Patient-activated cardioversion is delivered only if the implanted device is
currently detecting an AT/AF episode and the physician has programmed the device to
allow patient-activated cardioversion.
Contents of sterile package – The package contains one implantable cardioverter
defibrillator, one torque wrench, and one DF-1 pin plug.
1.3 Indications and usage
The Protecta XT DR system is indicated to provide ventricular antitachycardia pacing and
ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
In addition, the device is indicated for use in patients with atrial tachyarrhythmias, or those
patients who are at significant risk of developing atrial tachyarrhythmias.
Notes:
●
The use of the device has not been demonstrated to decrease the morbidity related to
atrial tachyarrhythmias.
●
The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in
terminating device classified atrial tachycardia (AT) was found to be 17%, and in
terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT
patient population studied.
●
The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in
terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in
terminating device classified atrial fibrillation (AF) was found to 18.2% in the AF-only
patient population studied.
1.4 Contraindications
The Protecta XT DR system is contraindicated for patients experiencing tachyarrhythmias
with transient or reversible causes including, but not limited to, the following: acute
myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance,
hypoxia, or sepsis.
The device is contraindicated for patients who have a unipolar pacemaker implanted.
The device is contraindicated for patients with incessant VT or VF.
The device is contraindicated for patients whose primary disorder is chronic atrial
tachyarrhythmia with no concomitant VT or VF.
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2 Warnings, precautions, and potential adverse events
2.1 General warnings and precautions
Anti-coagulation – Use of the device should not change the application of established
anti-coagulation protocols.
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 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.
Occurrence of stroke – Following an ischemic or cerebrovascular accident, disable atrial
cardioversion therapies until the patient has stabilized.
2.2 Explant and disposal
Consider the following information related to device explant and disposal:
●
Interrogate the device and disable tachyarrhythmia detection before explanting,
cleaning, or shipping the device. This prevents the device from delivering unwanted
shocks.
●
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.
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Medtronic PROTECTA™ XT DR D314DRG
●
Medtronic implantable devices are intended for single use only. Do not resterilize and
reimplant explanted devices.
●
Please use the Tachyarrhythmia Product Information Report to return explanted
devices to Medtronic for analysis and disposal.
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 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 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 has been dropped on a hard surface from
a height of 30 cm (12 in) or more after it is removed from its packaging.
“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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Medtronic PROTECTA™ XT DR D314DRG
2.4 Lead evaluation and lead connection
Refer to the lead technical manuals for specific instructions and precautions about lead
handling.
Hex wrench – Use only the torque wrench supplied with the device. The torque wrench is
designed to prevent damage to the device from overtightening a setscrew. Other torque
wrenches, (for example a blue-handled or right-angled hex wrench) have torque capabilities
greater than the lead connector can tolerate.
Lead connection – Consider the following information when connecting the lead and the
device:
●
Cap abandoned leads to avoid transmitting electrical signals.
●
Plug any unused lead ports to protect the device.
●
Verify lead connections. Loose lead connections may result in inappropriate sensing
and failure to deliver arrhythmia therapy.
Lead Impedance – Consider the following information about lead impedance when
evaluating the lead system:
●
Ensure that the defibrillation lead impedance is greater than 20 Ω. An impedance of
less than 20 Ω may damage the device or prevent delivery of high-voltage therapy.
●
Before 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 circuit a device and lead, causing electrical current to
bypass the heart and possibly damage the device and lead.
Patch leads – Do not fold, alter, or remove any portion of a patch lead. Doing so may
compromise electrode function or longevity.
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.
Atrial Capture Management – Atrial Capture Management 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, Atrial Capture Management may not prevent loss of capture.
Battery depletion – Carefully monitor battery longevity by checking battery voltage and
replacement indicators. Battery depletion eventually causes the device to stop functioning.
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Cardioversion and defibrillation are high-energy therapies that shorten battery longevity. An
excessive number of charging cycles also shortens battery longevity.
Charge Circuit Timeout or Charge Circuit Inactive – 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.
Concurrent pacemaker use – If a separate pacemaker is used concurrently with the ICD,
verify that the ICD does not sense the pacemaker output pulses because this can affect the
detection of tachyarrhythmias by the ICD. Program the pacemaker to deliver pacing pulses
at intervals longer than the ICD tachyarrhythmia detection intervals.
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 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. 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. Inform a Medtronic representative if your patient’s device has reset.
End of Service (EOS) indicator – Replace the device immediately if the programmer
displays an EOS indicator. The device may soon lose the ability to pace, sense, and deliver
therapy adequately.
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.
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Magnets – Positioning a magnet over the device suspends tachyarrhythmia detection but
does not alter bradycardia therapy. 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.
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.
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.
Rate control – Decisions regarding rate controls 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.
RV Capture Management – RV Capture Management 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, RV Capture Management may not prevent
loss of capture.
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.
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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.
Twiddler’s syndrome – Twiddler’s syndrome, the tendency of some patients to manipulate
their device after implant, may cause the pacing rate to increase temporarily if the device is
programmed to a rate-responsive mode.
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.
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 Warnings, precautions, and guidance for clinicians
performing medical procedures on cardiac device patients
This section is intended for physicians and other health care professionals who perform
medical procedures on patients with Medtronic implanted cardiac device systems and who
consult with the patients’ cardiologists. This section provides warnings, precautions, and
guidance related to medical therapies and diagnostic procedures that may cause serious
injury to a patient, interfere with a Medtronic implanted cardiac device system, or
permanently damage the system.
Note: Some common medical procedures that pose no risk are also listed in this section.
For additional guidance on medical procedures not addressed in this section, customers
can contact the following resources:
●
Customers in the United States can contact either of the following telephone numbers:
for pacemakers, contact Medtronic Technical Services at +1 800 505 4636; for ICDs,
contact Medtronic Technical Services at +1 800 723 4636. You may also submit
questions to tshelp@Medtronic.com or your Medtronic representative.
●
Customers outside of the United States can contact a Medtronic representative.
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Ablation (RF ablation or microwave ablation) – Ablation is a surgical technique in which
radio frequency (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 leads.
●
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, if appropriate for the patient, initiate
asynchronous pacing by implementing one of the following precautions;
●
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.
●
If appropriate for the patient, program the device to an asynchronous pacing mode (for
example, DOO). After the ablation procedure, remove the magnet or restore device
parameters.
Capsule endoscopy, pH capsule procedures – Capsule endoscopy is a procedure in
which a capsule containing a tiny camera is swallowed by the patient to take pictures of the
patient’s digestive tract. Capsule endoscopy and pH capsule procedures should pose no
risk of electromagnetic interference.
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:
●
Computed 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)
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●
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, if appropriate for the
patient, initiate asynchronous pacing by implementing one of the following precautions:
●
Suspend tachyarrhythmia detection by using a magnet or a programmer. After
completing the CT scan, remove the magnet or restore device parameters.
●
If appropriate for the patient, program the device to an asynchronous pacing mode (for
example, DOO). After completing the CT scan, 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 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 leads.
Therapeutic 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 leads.
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
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