Medtronic DDPC3D1 Reference Guide
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™
ICDs
Family of MR Conditional digital single-chamber and dual-chamber implantable cardioverter
defibrillators with SureScan™ technology
Reference Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™
ICDs
Reference Manual
A reference manual for the Medtronic Cobalt™ XT DR, Cobalt™ DR, Crome™ DR, Cobalt™ XT
VR, Cobalt™ VR and Crome™ VR families of digital implantable cardioverter defibrillators with
SureScan technology
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic.
Third-party trademarks (“TM*”) belong to their respective owners. The following list includes
trademarks or registered trademarks of a Medtronic entity in the United States and/or in other
countries.
Active Can™, ATP During Charging™, Capture Management™, Cardiac Compass™,
CareAlert™, CareLink™, ChargeSaver™, Cobalt™, Crome™, Flashback™, Intrinsic ATP™,
Marquis™, Medtronic CareAlert™, Medtronic CareLink™, MVP™, OptiVol™, PR Logic™,
Quick Look™, Reactive ATP™, SmartShock™, SureScan™, Switchback™, T-Shock™,
TruAF™
Medtronic
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™ ICDs
Contents
1 Introduction ............................................................ 8
1.1 About the product literature .......................................... 8
1.2 Device features .................................................... 9
2 Patient follow-up guidelines ............................................ 11
2.1 In-clinic follow-up appointments and remote monitoring ................ 11
2.2 Optimizing device longevity ........................................ 16
3 Diagnostic data features ............................................... 21
3.1 Quick Look summary data ......................................... 21
3.2 Medtronic CareAlert Monitoring ..................................... 23
3.3 OptiVol 2.0 Fluid Status Monitoring .................................. 30
3.4 RV Lead Integrity Alert ............................................. 35
3.5 Cardiac Compass Trends .......................................... 39
3.6 Heart Failure Management Report .................................. 47
3.7 Arrhythmia Episodes data .......................................... 49
3.8 Episode and therapy counters ...................................... 54
3.9 Flashback data ................................................... 57
3.10 Rate Drop Response episodes ..................................... 58
3.11 MVP mode switches data .......................................... 59
3.12 Rate Histograms ................................................. 59
3.13 Device and lead performance data .................................. 62
3.14 Automatic device status monitoring .................................. 66
4 Pacing features ....................................................... 69
4.1 Sensing in DR devices ............................................ 69
4.2 Sensing in VR devices ............................................. 79
4.3 Basic pacing for DR devices ........................................ 84
4.4 Basic pacing for VR devices ........................................ 95
4.5 Managed Ventricular Pacing (MVP) .................................. 98
4.6 Rate Response .................................................. 104
4.7 Capture Management ............................................ 109
4.8 Rate Adaptive AV ................................................ 120
4.9 Auto PVARP .................................................... 121
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4.10 Rate Drop Response ............................................. 124
4.11 Rate Hysteresis ................................................. 128
4.12 Sleep feature ................................................... 130
4.13 Non-Competitive Atrial Pacing ..................................... 131
4.14 PMT Intervention ................................................ 133
4.15 PVC Response .................................................. 135
4.16 Ventricular Safety Pacing ......................................... 136
4.17 Mode Switch .................................................... 138
4.18 Conducted AF Response in DR devices ............................ 141
4.19 Conducted AF Response in VR devices ............................ 143
4.20 Atrial Rate Stabilization ........................................... 145
4.21 Atrial Preference Pacing .......................................... 148
4.22 Post-Mode Switch Overdrive Pacing ................................ 152
4.23 Post Shock Pacing in DR devices .................................. 155
4.24 Post Shock Pacing in VR devices .................................. 156
4.25 Post VT/VF Shock Overdrive Pacing ................................ 156
4.26 Ventricular Rate Stabilization in DR devices ......................... 157
4.27 Ventricular Rate Stabilization in VR devices .......................... 159
5 Tachyarrhythmia detection features .................................... 163
5.1 AT/AF detection in DR devices ..................................... 163
5.2 AF detection in VR devices: the TruAF Detection algorithm ............ 169
5.3 VT/VF detection in DR devices .................................... 174
5.4 VT/VF detection in VR devices ..................................... 187
5.5 PR Logic ....................................................... 199
5.6 Wavelet ........................................................ 203
5.7 Onset .......................................................... 209
5.8 Stability ........................................................ 216
5.9 High Rate Timeout ............................................... 219
5.10 TWave Discrimination ............................................ 221
5.11 RV Lead Noise Discrimination ..................................... 224
6 Tachyarrhythmia therapy features ..................................... 228
6.1 Atrial therapy scheduling .......................................... 228
6.2 Atrial ATP therapies .............................................. 234
6.3 Atrial cardioversion ............................................... 245
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6.4 VF therapies in DR devices ........................................ 251
6.5 VF therapies in VR devices ........................................ 261
6.6 Ventricular ATP therapies ......................................... 272
6.7 Ventricular cardioversion in DR devices ............................. 285
6.8 Ventricular cardioversion in VR devices ............................. 294
6.9 Progressive Episode Therapies .................................... 302
Glossary ................................................................ 304
Index ................................................................... 313
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1 Introduction
1.1 About the product literature
This manual describes the operation and intended use of features offered by Medtronic
Cobalt XT DR and VR, Cobalt DR and VR, and Crome DR and VR MRI SureScan devices.
Throughout this manual, the word “device” refers to the implanted cardioverter defibrillator.
Unless otherwise noted, all device features described in this manual apply to the Cobalt XT
DR device or the Cobalt XT VR device, respectively. To determine which features are
available for another model in the Cobalt XT DR/VR, Cobalt DR/VR, and Crome DR/VR
families, refer to Table 1.
1.1.1 Product literature
Before implanting the device, it is recommended that you take the following actions:
• Read the product literature for information about prescribing, implanting, and using the
device and 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 give them any patient information materials packaged with the device.
Additional information about the device is provided in the following documents:
MRI technical manual – This manual provides MRI-specific procedures and warnings and
precautions.
Implantable device app help – The help explains how to use the implantable device app
to program the device settings and view the stored device data.
Device manual – This manual contains model-specific feature information, indications and
contraindications, warnings and precautions, instructions for implanting the device, quick
reference specifications, and parameter tables.
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, Precautions, and Guidance 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. This manual also includes information about hazards from sources of
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electromagnetic interference (EMI) in the patient’s home, recreational environments, and
occupational environments.
Radio regulatory compliance insert – This document provides compliance information
related to the radio components of the device.
1.1.2 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 telephone number or address listed on the back cover.
1.2 Device features
The following table lists the features in the Cobalt XT DR/VR, Cobalt DR/VR, and Crome
DR/VR device families that are not available in all devices. Features that are omitted from this
list apply to all DR devices, to all VR devices, or to every device in the portfolio.
Table 1. Product feature relationship
Cobalt XT MRI SureScan, Cobalt MRI SureScan, and Crome MRI
SureScan
DDPA2D4
Features
AF Alerts — — — X X —
TruAF Detection
algorithm
AT/AF Detection X X — — — —
Atrial ATP X X — — — —
Atrial Cardioversion
Atrial 50 Hz Burst
In-Office
Heart Failure Management Report
OptiVol 2.0 fluid
status monitoring
DDPA2D1
— — — X X —
X X — — — —
X X — — — —
X — — X — —
X — — X — —
DDPB3D4
DDPB3D1
DDPC3D4
DDPC3D1
DVPA2D4
DVPA2D1
DVPB3D4
DVPB3D1
DVPC3D4
DVPC3D1
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Table 1. Product feature relationship (continued)
Cobalt XT MRI SureScan, Cobalt MRI SureScan, and Crome MRI
SureScan
DDPA2D4
Features
Reactive ATP algorithm
SmartShock 2.0
technology
SmartShock 2.0+
technology with
Intrinsic ATP algorithm
a
Includes the following features: Confirmation+, PR Logic (DR devices only), RV Lead
a
b
DDPA2D1
X X — — — —
— X X — X X
X — — X — —
DDPB3D4
DDPB3D1
DDPC3D4
DDPC3D1
DVPA2D4
DVPA2D1
DVPB3D4
DVPB3D1
DVPC3D4
DVPC3D1
Integrity Alert, RV Lead Noise Discrimination, SVT Discriminators in VF Zone, TWave
Discrimination, and Wavelet
b
Includes the following features: Confirmation+, Intrinsic ATP algorithm, PR Logic (DR
devices only), RV Lead Integrity Alert, RV Lead Noise Discrimination, SVT Discriminators
in VF Zone, TWave Discrimination, and Wavelet
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2 Patient follow-up guidelines
2.1 In-clinic follow-up appointments and remote monitoring
Schedule regular in-clinic follow-up appointments with the patient throughout the service life
of the device. For patients enrolled in the Medtronic CareLink Network, remote monitoring
can replace the need for some in-clinic follow-up appointments. With remote monitoring,
data from a patient’s implanted device is sent to the Medtronic CareLink Network, and you
can review the transmitted data on the Medtronic CareLink Network website. Schedule
in-clinic follow-up appointments and CareLink transmissions as follows:
• Schedule an in-clinic follow-up appointment within 72 hours of implant so that the patient
can be checked for lead dislodgment, wound healing, and postoperative complications.
• Schedule an in-clinic follow-up appointment within 2 to 12 weeks after implant to
evaluate the condition of the patient, the device, and the leads, and to verify that the
device is configured appropriately for the patient.
• Schedule routine CareLink transmissions or in-clinic follow-up appointments every 3 to
6 months with in-clinic follow-up appointments occurring at least annually.
• When the device battery approaches Recommended Replacement Time (RRT),
schedule CareLink transmissions or in-clinic follow-up appointments every 1 to 3
months.
• Schedule in-clinic follow-up appointments as needed (for example, if data from a
CareLink transmission indicates that the patient’s device requires adjustment).
2.1.1 Remote monitoring options
The device provides automatic wireless remote monitoring, if available, through a
patient-owned smart phone or tablet running a mobile app (referred to as the patient app) or
through a home communicator. This device features Bluetooth® wireless technology1.
Routine monitoring transmissions occur according to a schedule that you create on the
Medtronic CareLink Network website. In addition, the CareAlert Monitoring feature provides
automatic, unscheduled transmissions for specific clinical or device status events (see
Section 3.2, Medtronic CareAlert Monitoring, page 23). Patients can also send
unscheduled transmissions.
1
The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by
Medtronic is under license.
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Note: When viewing a CareLink transmission, the data collected since the last session is
presented differently than it is for a patient session. For a CareLink transmission, the last
session is defined as either the last patient session or the last CareLink transmission. During
an in-clinic appointment, the last session is defined as the last patient session.
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™ ICDs
2.1.2 Follow-up process
The process for conducting a follow-up evaluation, either during an in-clinic appointment or
with a CareLink transmission, includes the following steps:
1. Review the patient’s presenting rhythm.
2. Verify the status of the implanted system.
3. Verify the clinical effectiveness of the implanted system.
4. During an in-clinic follow-up appointment, adjust device parameters as necessary.
5. If evaluating data remotely, schedule an in-clinic follow-up appointment as necessary.
2.1.3 Reviewing the presenting rhythm
The presenting rhythm may indicate the presence of undersensing, far-field oversensing, or
loss of capture. The presence of these basic pacing issues can affect the delivery of therapy.
These issues can often be resolved by making basic programming changes.
Review the presenting rhythm as follows:
• During an in-clinic follow-up appointment, view the Live Rhythm Monitor and record the
EGM and marker traces.
• For remote monitoring, review the EGM data that was recorded at the time of the
CareLink transmission.
Viewing this information can help you identify any issues with the patient’s presenting
rhythm. It may be necessary to adjust the pacing parameters.
2.1.4 Verifying the status of the implanted system
To verify the status of the implanted system, perform the following tasks:
• Assess the battery status.
• Check lead measurements and trend data.
• Review any Quick Look observations about the device and lead status.
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2.1.4.1 Assessing the battery status
To assess the status of the device battery, review the REMAINING LONGEVITY estimate on
the Quick Look screen. If the device battery has reached a replacement threshold, the
associated indicator is displayed.
To see more detail about the battery status, including battery voltage, tap REMAINING
LONGEVITY on the Quick Look screen to see the device data provided by the BATTERY
AND LEAD MEASUREMENTS window.
Warning: Replace the device immediately if the End of Service (EOS) indicator is displayed.
The device may lose the ability to pace, sense, and deliver therapy adequately after the
battery reaches End of Service.
If the Recommended Replacement Time (RRT) indicator or the Elective Replacement
Indicator (ERI) is displayed, or if the battery voltage is at or below the displayed RRT voltage,
contact your Medtronic representative and schedule a replacement procedure with your
patient. For more information about the replacement indicators, see Section 3.13, Device
and lead performance data, page 62.
2.1.4.2 Checking lead measurements and trend data
In-clinic follow-up appointment – During an in-clinic follow-up appointment, you can
check the status of the implanted leads. On the Quick Look screen you can review up to 12
months of the following lead trend data:
• Lead impedance
– Pacing (Ω)
– Defib (Ω)
• THRESHOLD (V @ ms)—shows P-wave and R-wave threshold trends
• AMPLITUDE (mV)—shows capture amplitude trends
For a more detailed history of each trend, tap LEAD TRENDS.
For more information about the automatic collection of these trends, see Section 3.13,
Device and lead performance data, page 62.
To gather real-time information about the performance of the device and leads, perform the
following tests:
• LEAD IMPEDANCE
• PACING THRESHOLD
• SENSING
For more information about these tests, refer to the implantable device app help.
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Evaluating a CareLink transmission – When evaluating a CareLink transmission, you can
check the status of implanted leads by reviewing the most recent lead impedance, capture
threshold, and sensing amplitude measurements on the Quick Look report. Compare these
values to the patient history and to the trend data provided on the Lead Trends reports.
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™ ICDs
2.1.4.3 Reviewing Quick Look observations about the status of the device, the leads, and the alert events
The Quick Look data includes observations that are based on an analysis of the
programmed parameters and the collected data. Observations may include information
about the status of the device and the battery and the integrity of the implanted leads or
potential issues with the programmed parameter settings. If Medtronic CareAlert Monitoring
is enabled, any alert events detected by the device are presented in the OBSERVATIONS
section of the Quick Look screen. Review these observations and check related reports for
evidence of a problem with the device or the leads.
2.1.5 Verifying the clinical effectiveness of the implanted system
You can use the information available on the Quick Look screen and the saved reports to
assess whether the device is providing adequate clinical support for the patient.
2.1.5.1 Reviewing Quick Look observations about clinical status
The Quick Look data includes observations about noteworthy or abnormal patient
conditions such as low patient activity, unexpectedly high rates, or high arrhythmia burden.
If you enable Medtronic CareAlert Monitoring, the OBSERVATIONS section of the Quick
Look screen lists alert events detected by the device. To evaluate the clinical effectiveness
of the implanted system, review this event data and check the related data.
2.1.5.2 Assessing the effectiveness of pacing therapy
1. Review the pacing percentages in the Quick Look data. To assess the patient’s pacing
and sensing history in more detail, review the rate histograms data. For more
information, see Section 3.12, Rate Histograms, page 59.
2. Review Cardiac Compass Trends data and compare it with the patient history. Cardiac
Compass Trends data can help you to determine whether changes in the patient’s
activity, pacing therapies, and arrhythmias have occurred during the past 14 months.
For more information about the data collected by the Cardiac Compass feature, see
Section 3.5, Cardiac Compass Trends, page 39.
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3. Evaluate the patient’s pacing thresholds by reviewing capture threshold trend data.
During an in-clinic follow-up appointment, you can also perform a Pacing Threshold
Test. Refer to the implantable device app help for more information about conducting
these tests.
4. Check the programmed pacing parameters to confirm that they provide an appropriate
safety margin.
5. During in-clinic follow-up appointments, interview the patient to confirm that the patient
is receiving adequate cardiac support for activities of daily living.
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™ ICDs
2.1.5.3 Assessing tachyarrhythmia detection
1. Review the Quick Look data for the counts of each kind of tachyarrhythmia episode.
2. Review the Cardiac Compass Trends data and the Rate Histograms data to assess the
frequency of arrhythmias and device therapies in consideration of patient condition. For
more information, see Section 3.5, Cardiac Compass Trends, page 39 and
Section 3.12, Rate Histograms, page 59.
Episode misidentification – If the episode records indicate that the device has
misidentified the patient’s rhythm, carefully review the tachyarrhythmia episode and sensing
integrity data, the Cardiac Compass Trends data, and the data stored for other episodes.
Consider adjusting the detection parameters and the SVT detection criteria as needed. For
more information about how to view sensing integrity data, see Section 4.1, Sensing in DR
devices, page 69 and Section 4.2, Sensing in VR devices, page 79.
Caution: Use caution when reprogramming the detection or sensing parameters to ensure
that changes do not adversely affect VF detection. Ensure that appropriate sensing is
maintained. For more information, see Section 4.1, Sensing in DR devices, page 69 and
Section 4.2, Sensing in VR devices, page 79.
2.1.5.4 Assessing tachyarrhythmia therapy
1. Review any Medtronic CareAlert notifications in the Quick Look OBSERVATIONS
section that relate to therapy delivery. To see detailed information about Medtronic
CareAlert notifications, tap DATA > CareAlert EVENTS from the Menu button.
2. Check tachyarrhythmia episode records to determine the effectiveness of therapies
that have been delivered.
3. Adjust the therapy parameters as needed.
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2.1.6 Adjusting device parameters
Adjust the pacing, tachyarrhythmia detection, tachyarrhythmia therapy, and diagnostic data
parameters as needed to address any issues identified during the follow-up appointment.
Caution: Use caution when reprogramming the detection or sensing parameters to ensure
that appropriate sensing is maintained. For more information, see Section 4.1, Sensing in
DR devices, page 69 and Section 4.2, Sensing in VR devices, page 79.
2.1.7 Scheduling an in-clinic follow-up appointment
Data transmitted to the Medtronic CareLink Network may indicate the need to schedule an
in-clinic follow-up appointment with your patient in addition to the patient’s regularly
scheduled appointments. You may need to perform manual tests, adjust device parameters,
or assess lead status more directly. The following table shows an example of how data from
a CareLink transmission may be used to make scheduling decisions.
Table 2. Example: Responses to different kinds of CareLink transmissions
Device and lead
status
Normal Normal According to the regular schedule
Normal Abnormal, but no urgent or emer-
Normal Abnormal, urgent condition Within 1 week
Normal Abnormal, emergency condition Immediately
Abnormal Any Immediately
Clinical status
gency conditions
When to schedule an in-clinic follow-up appointment
According to the regular schedule
2.2 Optimizing device longevity
Optimizing device longevity is a desirable goal because it can reduce the frequency of
device replacement for patients. Optimizing device longevity requires balancing the benefit
of device therapy and diagnostic features with the energy requirements placed on the battery
as a result of these features.
To view the REMAINING LONGEVITY estimate for the device, refer to the Quick Look
screen.
Note: The remaining longevity estimate is updated when parameters are reprogrammed
and when the device is interrogated.
The following sections describe strategies that can help reduce the energy requirements
placed on the battery.
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2.2.1 Promoting intrinsic AV conduction
MVP (Managed Ventricular Pacing) – The MVP feature promotes AV conduction by
reducing unnecessary right ventricular pacing. The primary benefit of the MVP feature is
therapeutic, but it may also preserve device longevity as a result of a decrease in the
percentage of pacing. For more information, see Section 4.5, Managed Ventricular Pacing
(MVP), page 98.
Promoting AV conduction with longer AV intervals – Another method of promoting AV
conduction is to increase the paced AV interval and the sensed AV interval. This action
allows intrinsic conduction to occur before a ventricular pace. Fewer pacing pulses may help
to preserve device longevity. For more information, see Section 4.3, Basic pacing for DR
devices, page 84.
2.2.2 Managing pacing outputs
Capture Management – The Capture Management feature provides the device with
automatic monitoring and follow-up capabilities for managing pacing thresholds. This
feature is designed to monitor the pacing threshold and, optionally, to adjust the pacing
outputs to maintain capture. Programming the Capture Management feature allows the
device to set the pacing amplitude just high enough to maintain capture while preserving
battery energy. For more information, see Section 4.7, Capture Management, page 109 .
Manual optimization of amplitude and pulse width – If you choose to program the
Capture Management feature to Off, you can optimize the patient’s pacing output
parameters manually. Perform a Pacing Threshold Test to determine the patient’s pacing
thresholds. Select amplitude and pulse width settings that provide an adequate safety
margin above the patient’s pacing threshold. These actions decrease the pacing outputs
and preserve battery energy. Refer to the implantable device app help for more information
about performing a Pacing Threshold Test.
Pacing rate – The more paced events that are delivered, the more device longevity is
reduced. Make sure that you have not programmed an unnecessarily high pacing rate for the
patient. Carefully consider using features that increase the bradycardia pacing rate. Use
features such as Atrial Preference Pacing (APP), Conducted AF Response, and Rate
Response only for patients who can receive therapeutic benefit from the feature.
2.2.3 Optimizing tachyarrhythmia therapy settings
Defibrillation – To treat ventricular fibrillation episodes, the device may deliver defibrillation
therapy to terminate the episode and restore the patient’s normal sinus rhythm. The device
can be programmed to deliver a sequence of up to 6 defibrillation therapies. Although
defibrillation therapy expends a high level of energy, VF therapies should be programmed to
the maximum energy level.
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Atrial cardioversion – You can program a DR device to deliver automatic atrial
cardioversion (CV) therapies to treat atrial tachyarrhythmia episodes. If you choose to treat
the patient with atrial CV therapies, you can extend device longevity by carefully considering
how you program the following parameters: the number of shocks delivered during a 24-hour
cycle and the Episode Duration before CV. It is recommended that CV therapy be set to full
energy to terminate the arrhythmia. For more information, see Section 6.3, Atrial
cardioversion, page 245.
Ventricular cardioversion – If you are providing ventricular cardioversion therapies for the
patient, consider programming the therapy energy to a value lower than the maximum
energy but high enough to terminate the VT. However, at least one VT therapy and one FVT
therapy in a sequence should be programmed to the maximum energy level. For more
information, see Section 6.7, Ventricular cardioversion in DR devices, page 285 and
Section 6.8, Ventricular cardioversion in VR devices, page 294.
FVT via VF detection – An FVT detection zone can be used to detect and treat a VT episode
that is in the rate zone for VF. This approach can help maintain reliable detection of VF while
allowing ATP to be delivered for fast VT episodes. For more information, see Section 5.3, VT/
VF detection in DR devices, page 174 and Section 5.4, VT/VF detection in VR devices,
page 187.
Antitachycardia pacing (ATP) – ATP therapies interrupt the tachycardia episode and
restore the patient’s normal sinus rhythm. ATP therapies deliver pacing pulses instead of the
high-voltage shocks that are delivered in cardioversion therapy and defibrillation.
ATP therapy requires less battery energy than cardioversion or defibrillation. For some
patients, you may be able to program the device to deliver ATP therapies before delivering
high-voltage therapies.
For more information about ATP and atrial episodes, see Section 6.2, Atrial ATP therapies,
page 234. For more information about ATP and ventricular episodes, see Section 6.6,
Ventricular ATP therapies, page 272.
Delivering ATP before the first defibrillation – You can program the device to deliver ATP
as the first defibrillation therapy before the device is charged. This action can prevent
delivery of high-voltage therapy for rhythms that can be terminated by ATP (rapid,
monomorphic VT, for example).
If you program the ChargeSaver feature to On, the device can also automatically switch to
the ATP Before Charging operation. This switch allows the device to attempt a sequence of
ATP therapy before charging the capacitors to treat a detected VF episode. For more
information, see Section 6.4, VF therapies in DR devices, page 251 and Section 6.5, VF
therapies in VR devices, page 261.
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2.2.4 Disabling atrial sensitivity
Atrial sensitivity – For DR devices, when an atrial lead is not present or when atrial
monitoring is not needed due to chronic AT/AF, program Atrial Sensitivity to Off before
changing the mode to VVI or VVIR to preserve battery energy.
Note: When Atrial Sensitivity is programmed to Off, AT/AF monitoring and PR Logic are
disabled.
2.2.5 Considering how diagnostic features with data storage impact longevity
Pre-arrhythmia EGM storage – When the device is set to nominal parameters, it provides
continuous Pre-arrhythmia EGM storage with minimal longevity impact. If the parameters for
EGM storage or sense polarity are changed, the device may be required to keep additional
EGM circuitry enabled at all times, which reduces device longevity. You can preserve
longevity by ensuring that the stored EGM channels use EGM SOURCE values that match
the Sense Polarity values.
If it is necessary to store EGM from a source that does not match the sense polarity, consider
the following information about the Pre-arrhythmia EGM feature:
• The Pre-arrhythmia EGM feature allows the device to collect up to 20 s of EGM data
before the onset of VT/VF, VT Monitor, SVT, VT-NS, and Fast A&V episodes.
• The Pre-arrhythmia EGM feature does not apply to AT/AF episodes. The device stores
approximately 4 s of EGM before AT/AF detection, regardless of the Pre-arrhythmia
EGM storage setting.
• When Pre-arrhythmia EGM storage is set to Off, the device begins to store EGM
information for VT/VF, VT Monitor, and SVT episodes after the third tachyarrhythmia
event occurs. Though EGM is not recorded before the start of the arrhythmia, the device
still records up to 20 s of data before the onset or the detection of the episode. This data
includes interval measurements and markers. In addition, Flashback data is stored for
the most recent tachyarrhythmia episodes.
• For a patient with uniform tachyarrhythmia onset mechanisms, the greatest benefit of
Pre-arrhythmia EGM storage is obtained after capturing a few episodes. Program
Pre-arrhythmia EGM to Off after you have obtained the data of interest.
Holter telemetry – Extended use of the Holter telemetry feature decreases device
longevity. The Holter telemetry feature continues to transmit EGM and marker data for the
programmed time duration, regardless of whether the patient connector is positioned over
the device.
Medtronic CareLink remote transmissions – When scheduling Medtronic CareLink
remote transmissions, be aware that increasing the frequency of remote transmissions
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reduces the service life of the implanted device. Refer to the device manual for more
information about the estimated effect on a specific device model. To conserve battery
energy, schedule the lowest frequency of remote transmissions that still allows for the
desired monitoring of your patient’s device.
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™ ICDs
2.2.6 Extended wireless telemetry session
If the implantable device app detects no activity for 45 min, a pop-up window prompts you to
extend the session. If you do not tap EXTEND to extend the session, the patient session
ends in 15 min.
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3 Diagnostic data features
3.1 Quick Look summary data
At the start of a patient session, it is useful to quickly view summary information about device
operation and the patient’s condition. This overview can help you to determine whether you
need to look more closely at diagnostic data or reprogram the device to optimize therapy for
the patient.
The Quick Look data summarizes the most important indicators of system operation and the
patient’s condition. These indicators include device and lead status data, pacing therapy
information, arrhythmia episode data, and system-defined observations.
You can view Quick Look data on the Quick Look screen, which is displayed at the beginning
of a patient session. To return to the Quick Look screen from another screen, tap Quick
Look from the Menu button. For more information about using the Quick Look screen, refer
to the implantable device app help.
Note: The Quick Look screen shows information collected since the last patient session and
stored in device memory. Programming changes made during the current session can affect
the Quick Look observations.
3.1.1 Quick Look device and lead status information
The Quick Look data includes the following information about device and lead status:
• Estimate of remaining battery longevity
• Trends of the weekly average impedance, capture threshold, and wave amplitude
measurements
• Most recent measured values for impedance, capture threshold, and wave amplitude
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3.1.2 Quick Look pacing therapy information
The Quick Look data includes the following information about pacing therapy, listed under
the % OF TIME label:
• For DR devices, the percentage of time in atrial pacing (AP) since the last patient
session; and for DR and VR devices, the percentage of ventricular pacing (VP) since the
last patient session
• For DR devices, the percentage of time pacing in AS-VP event sequences
• For DR devices, an indicator that the pacing mode is programmed to an MVP mode
(MVP On) or to another pacing mode (MVP Off)
3.1.2.1 Quick Look arrhythmia episode information
The Quick Look data includes the following information about arrhythmia episodes since the
last patient session:
• Percentage of time spent in AT/AF
• Number of VT/VF episodes treated with tachyarrhythmia therapy
• Number of AT/AF episodes treated with tachyarrhythmia therapy
• Number of delivered shocks
• Number of monitored VT episodes
• Number of monitored SVT episodes
• Number of monitored AT/AF episodes
3.1.2.2 Quick Look observations
Observations are based on an analysis of programmed parameters and data collected since
the last session. The following types of observations may occur:
• Device status observations inform you of conditions that affect device operation and
require attention. Examples of such conditions include Recommended Replacement
Time (RRT) or the occurrence of a device reset.
• Lead status observations report any potential issues with the sensing integrity of the
leads, possible lead dislodgments, and abnormal Capture Management results. You
may also be warned about possible inconsistencies in the programming of lead polarity.
• Parameter observations warn of any inconsistencies in the programming of detection
and therapy parameters. An example is certain parameter settings resulting in a therapy
being disabled.
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• Diagnostic data observations report noteworthy arrhythmia episodes. Examples include
arrhythmias of different types occurring together and episodes for which therapies were
unsuccessful. Conditions that prevent diagnostic data from being collected effectively
are also reported.
• Medtronic CareAlert observations can report system or device performance conditions
and certain heart rhythm conditions. For more information, see Section 3.2, Medtronic
CareAlert Monitoring, page 23.
• Clinical status observations alert you to abnormal patient conditions, such as low activity
rates, unexpectedly high heart rates, high arrhythmia burden, or fluid accumulation.
If you tap an observation that includes additional details, a > button appears at the end of the
OBSERVATIONS field. To see the observation details, tap the > button.
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™ ICDs
3.2 Medtronic CareAlert Monitoring
Important clinical management and system performance events can occur between
scheduled patient sessions. These events can relate to clinical management data, to
inappropriately programmed settings, or to system performance issues that must be
investigated. The early detection and notification of these events, if they occur, enable you
to intervene promptly with appropriate care for your patient.
The device continuously monitors for a specified set of clinical management and system
performance events that can occur between scheduled follow-up sessions. If the device
detects that such an event has occurred and if alerting parameters are programmed to On,
Medtronic CareAlert Monitoring responds in the following ways:
• Patient alert
• Wireless signal and network transmission of event information
Medtronic CareAlert Monitoring continuously monitors for alert events. If an event
occurs, CareAlert Monitoring sends alert data about specified clinical management or
system performance events to the Medtronic CareLink Network (if available). Alert data
is sent through the patient’s personal wireless device or through a Medtronic home
communicator.
• Notification of alert event
Depending on the severity of the alert condition, you can set up Medtronic CareAlert
notifications through the CareLink Network (if available). You can hold the alert for
routine review on the CareLink website, or you can be notified by the following
notification methods, according to your preferences:
– Email
– Text message
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– Pager
– Automated voice message
– Telephone call
Note: CareAlert notification methods, when available, vary from geography to geography.
3.2.1 Operation of Medtronic CareAlert Monitoring
If a clinical event or a system performance event occurs, and the device is programmed to
notify you over the CareLink Network, the CareAlert Monitoring feature transmits alert data
from the device to the patient app or the home communicator. The patient app or the home
communicator then sends the alert data to the CareLink Network. The CareLink Network
records the alert, then notifies you according to your preferences.
If an alert data transmission from the device is unsuccessful, the CareAlert Monitoring
feature tries to establish communication with the patient app or the home communicator
every 3 hours until the data transmission is successful. If the alert data remains
untransmitted for 72 hours, the device emits a tone at the Alert Time that you select for your
patient or at intervals unique to some alerts as described in Section 3.2.3.1 and
Section 3.2.3.2.
Note: After a wireless alert signal is successfully transmitted, the device does not retransmit
data for that alert until the alert is cleared. There is one exception to this rule: a device reset
alert is transmitted each time a device reset occurs. There are 2 exceptions to this rule: a
device reset alert is transmitted each time a device reset occurs, and an OptiVol Event alert
is transmitted each time the patient’s fluid level exceeds the OptiVol Threshold following a
reset of the OptiVol 2.0 Fluid Index (see Section 3.3, OptiVol 2.0 Fluid Status Monitoring,
page 30).
The CareAlert notification methods (any one or a combination of voice message, text
message, pager, email, live call, or website-only) can be programmed to On or Off, on a
per-patient and per-clinic basis, and according to time of day.
3.2.2 Operation of Medtronic CareAlert events
Medtronic CareAlert events are either programmable or always on:
• Clinician-defined alerts can be programmed on or off.
• System-defined alerts are always on.
Alerts are displayed in the OBSERVATIONS area of the Quick Look screen.
2
CareAlert notification methods, when available, vary from geography to geography.
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When an alert is initiated, the device sounds a tone either at a selected time of day or at a
fixed time interval. The tone then sounds each day at the selected time or interval until it is
cleared through interrogation by the implantable device manager. Active tones also sound
when the patient magnet is placed over the device. You can view alert details during a patient
session.
Notes:
• A CareLink transmission does not clear an alert tone. The tone will continue to sound
until the alert is cleared in the office (or if the DEVICE TONE is set to Off).
• Once an alert has been transmitted over the CareLink Network (if available), further
transmissions for that alert condition will not occur until the alert is cleared.
• OptiVol alert tones stop sounding if the OptiVol 2.0 Fluid Index reaches 0. If the Fluid
Index threshold is crossed again, another CareLink transmission is initiated and OptiVol
alert tones sound at the programmed times.
• All alerts are cleared automatically when the device is interrogated with a device
manager.
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™ ICDs
3.2.2.1 Patient alert process
The device can be programmed to sound a tone to alert the patient when a clinical
management event or a system performance event occurs. However, the patient will not be
able to determine the nature of the alert. Instruct your patients to call the clinic if they hear a
device tone.
The alert event determines when the device tone will sound: when the event occurs, at a
programmed time of day, or at fixed intervals. Device tones sound for up to 30 s, and they are
slightly louder than the ambient noise in a typical living room.
For more information about patient alerts, refer to the implantable device app help.
3.2.2.2 Instructing the patient
It is important that patients understand that they may hear device tones emitted from their
implanted device. They must know what to do when a device tone sounds.
Warning: Make sure that patients understand that they must not carry, store, or leave the
patient magnet positioned over the device. Device operation is temporarily impaired when
the magnet is placed over the device and it must be moved away from the device to restore
normal operation.
• Instruct patients to contact you immediately if they hear ANY tones from the device.
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• Tell patients the time of day that you have programmed an alert tone to sound. If a tone
sounds, patients should expect it to sound every day at that time until the alert is cleared
(or until DEVICE TONE is programmed to Off).
• Advise patients that if an alert is not successfully transmitted to their personal mobile
devices or to a Medtronic home communicator within 72 hours, a tone sounds each day
at the programmed alert time.
• Advise patients that the alert time does not adjust for time zone changes.
• Advise patients that they may hear a steady test tone or any active alert tones if they are
in the presence of a strong electromagnetic field, such as the field within a store theft
detector. Advise patients that the device operation is temporarily impaired in these
situations and that they should move away from the source of the interference to restore
normal device operation.
Patients should also understand the purpose of the patient magnet and how and when to use
it. Make sure that they know that current patient alerts sound when the patient magnet is
placed over the device. Demonstrate how to place the patient magnet over the device to
replay the alert tones, and review the patient magnet manual with them.
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™ ICDs
3.2.3 Clinical management and system performance event alerts
3.2.3.1 Clinical management event alerts
Possible OptiVol fluid accumulation – This alert indicates that the OptiVol 2.0 Fluid Index
has met or exceeded the programmed OptiVol Threshold.
AT/AF Daily Burden – This alert indicates that the cumulative time in AT/AF exceeds the
programmed threshold.
Avg. V. Rate During AT/AF – This alert indicates that the average ventricular rate during a
selectable duration of AT/AF exceeds the programmed threshold.
Monitored VT Episode Detected – This alert indicates that 1 or more monitored VT
episodes have been detected.
Daily VT/VF Episodes – This alert indicates that the total number of daily VT/VF episodes
is greater than or equal to 3 episodes.
Weekly ATP Delivered Episodes – This alert indicates that the number of episodes treated
with antitachycardia pacing is greater than or equal to the programmed threshold, per week.
Number of Shocks Delivered in an Episode – This alert indicates that the number of
shocks delivered in a VT/VF episode is greater than or equal to the programmed Number of
Shocks Threshold value.
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Cumulative Right Ventricular Pacing > 40% – This alert indicates that the cumulative
percentage of ventricular pacing over the most recent 7 days was greater than 40%.
Cobalt™ XT / Cobalt™ / Crome™ DR/VR MRI SureScan™ ICDs
3.2.3.2 System performance event alerts
RV Lead Integrity – This alert indicates that an RV lead problem is suspected, which could
indicate lead fracture. The device immediately sounds an alert tone that lasts for 30 s. This
tone repeats every 4 hours, beginning at the next scheduled 4-hour time interval, and at the
programmed Alert Time….
RV Lead Noise – This alert indicates that noise was detected on the RV lead, which could
indicate lead fracture, breached lead insulation, lead dislodgement, or improper lead
connection. The device sounds an alert tone 3 min after a lead noise episode is detected.
This tone repeats every 4 hours, beginning at the next scheduled 4-hour time interval, and
at the programmed Alert Time….
Lead Impedance Out of Range… – These alerts indicate that the daily lead impedance
measurement for one of the implanted leads is out of range. These alerts could indicate that
a lead has dislodged or is improperly connected. For all leads, the device sounds an alert
tone at the programmed Alert Time…. For the RV Pacing, RV Defibrillation and SVC
Defibrillation leads, the device sounds an alert tone and repeats this tone every 4 hours,
beginning at the next scheduled 4-hour time interval.
Capture Management High Threshold… – These alerts indicate high capture threshold
measurements. During Right Ventricular Capture Management and Atrial Capture
Management operation, an alert occurs when 3 consecutive daily measurements are high.
Low Battery Voltage RRT – This alert indicates that the daily automatic battery voltage
measurement has been at or below the Recommended Replacement Time (RRT) voltage
level for 3 consecutive days. When RRT has been met, the device has less than 3 months to
the Elective Replacement Indicator (ERI).
Excessive Charge Time EOS… – This alert indicates that the charging period equals or
exceeds the charge time threshold.
VF Detection OFF, 3+VF or 3+FVT Rx Off – These alerts indicate that one or more of the
following conditions has occurred for at least 6 hours since the last programming: VF
detection has been turned off; 3 or more VF therapies have been turned off; or FVT detection
is programmed to FVT via VF and 3 or more FVT therapies have been turned off. Note that
this alert sounds immediately and then every 6 hours until cleared.
For details about programmable settings for a particular parameter, see the device manual
for the specific device.
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3.2.3.3 Non-programmable system performance event alerts
Pacing Mode DOO, VOO, or AOO – This alert indicates that the device is programmed to
a DOO, a VOO, or an AOO pacing mode and, as such, does not deliver tachyarrhythmia
therapy. The device sounds a tone daily at the programmed time.
Active Can Off without SVC – This alert indicates that the Active Can feature is disabled
without an SVC lead in place, which does not provide a viable defibrillation pathway. The
device sounds a tone daily at the programmed time.
Rapid Current Drain EOS indicated – This alert indicates that the battery voltage is
declining faster than expected at the time that low battery Recommended Replacement
Time (RRT) has been detected. This situation reduces the 3-month Prolonged Service
Period to device End of Service (EOS). If this alert condition is met, the device sounds a
continuous patient alert tone for 30 s. This patient alert tone repeats every 4 hours, beginning
at the next scheduled 4-hour time interval, and at the programmed Alert Time. Immediately
contact your Medtronic representative if a Rapid Current Drain EOS alert occurs.
Unsuccessful Wireless Transmission – This alert indicates that the device attempted a
wireless transmission but that the transmission was still unsuccessful after a 72-hour period.
3.2.4 Programming Alerts
The Medtronic CareAlert SETUP screen shows either a Lead/Device Integrity Alerts view or
a Clinical Management Alerts view. To toggle between views, tap either Clinical
Management Alerts… or Lead/Device Integrity Alerts….
Table 3. How to navigate to parameters for Lead/Device Integrity Alerts from the Menu
a
button
Parameters Path
Wireless Telemetry with Monitor
Alert Time…
RV Lead alert parameters:
RV Lead Integrity
RV Lead Noise
PARAMETERS > Alert…
PARAMETERS > Alert… > RV Lead… WIRELESS ALERT
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Table 3. How to navigate to parameters for Lead/Device Integrity Alerts from the Menu
buttona (continued)
Parameters Path
Lead Impedance Out of Range alert parameters:
A. Pacing ENABLE
A. Pacing LESS THAN
A. Pacing GREATER THAN
RV Pacing ENABLE
RV Pacing LESS THAN
RV Pacing GREATER THAN
RV Defibrillation ENABLE
RV Defibrillation LESS THAN
RV Defibrillation GREATER THAN
SVC Defibrillation ENABLE
SVC Defibrillation LESS THAN
SVC Defibrillation GREATER THAN
Capture Management High Threshold
parameters:
A. Capture ENABLE
RV Capture ENABLE
Low Battery Voltage RRT
Excessive Charge Time EOS…
VF Detection OFF, 3+ VF or 3+ FVT Rx Off.
a
The Lead/Device Integrity Alerts… label shares a toggle field with the Clinical
PARAMETERS > Alert… > Lead/Device
Integrity Alerts… > Lead Impedance Out of
Range… WIRELESS ALERT
PARAMETERS > Alert… > Lead/Device
Integrity Alerts… > Capture Management High
Threshold… WIRELESS ALERT
PARAMETERS > Alert… > Lead/Device
Integrity Alerts… WIRELESS ALERT
Management Alerts… label.
Table 4. How to navigate to parameters for Clinical Management Alerts from the Menu
a
button
Parameters Path
Wireless Telemetry with Monitor
Alert Time (OptiVol)…
Alert Time…
OptiVol 2.0 Fluid Settings parameters
OptiVol Alert Enable
OptiVol Threshold
AT/AF Burden and Rate Settings parameters
AT/AF Daily Burden ENABLE
AT/AF Daily Burden BURDEN
Avg. V. Rate During AT/AF ENABLE
Avg. V. Rate During AT/AF BURDEN
Avg. V. Rate During AT/AF V. RATE
PARAMETERS > Alert…
PARAMETERS > Alert… > OptiVol 2.0 Fluid Settings… WIRELESS ALERT
PARAMETERS > Alert… > AT/AF Burden and
Rate Settings… WIRELESS ALERT
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Table 4. How to navigate to parameters for Clinical Management Alerts from the Menu
buttona (continued)
Parameters Path
VT/VF Episodes and Therapies parameters
Monitored VT Episode Detected ENABLE
Daily VT/VF Episodes ENABLE
Weekly ATP Delivered Episodes ENABLE
Weekly ATP Delivered Episodes THRESHOLDS
Number of Shocks Delivered in an Episode ENABLE
Number of Shocks Delivered in an Episode
THRESHOLDS
Cumulative Right Ventricular Pacing > 40% PARAMETERS > Alert…
a
The Clinical Management Alerts… label shares a toggle field with the Lead/Device
PARAMETERS > Alert… > VT/VF Episodes and
Therapies… WIRELESS ALERT
Integrity Alerts… label.
Transmitting alerts – The ability to transmit Medtronic alerts to the CareLink Network is
programmable only when the Wireless Telemetry with Monitor parameter on the Medtronic
CareAlert SETUP screen is programmed to On.
Repetitive alerts – If a programmable alert is triggered so often that it loses its clinical value,
you can adjust the alert threshold, program the device to improve therapy effectiveness, or
turn off the alert.
3.2.5 Evaluation of alert events
The Medtronic CareAlert EVENTS log categorizes alert events as CareAlert EVENTS and
OptiVol EVENTS. For each alert event, a log entry includes the date and time of the alert, a
description of the event, and the measurement or information that caused the event. Up to 15
CareAlert events and the last 7 OptiVol events are stored.
Caution: Verify lead integrity when evaluating OptiVol events. Loss of RVcoil integrity due to
lead fracture or insulation defect may adversely affect OptiVol events.
From the Menu button, tap DATA > CareAlert EVENTS to see the alert events stored in the
Medtronic CareAlert EVENTS log.
3.3 OptiVol 2.0 Fluid Status Monitoring
Clinical studies have shown that lung congestion is a primary complication associated with
heart failure and is a frequent cause of repeated hospital admissions.
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