Gallant™ and Entrant™

HF CRT-D

A H E A LT H I E R
TO M O R R O W
S TA R T S T O D AY

TAKE THE FIRST STEP

TO A HEALTHIER YOU.
Download the myMerlinPulse™ app today.
TA K I N G T H E
N E X T S T E P,
TOGETHER
As part of the Abbott family, you
can rest assured that we are with WE’RE HERE
you for every step of your health
journey. We see a better life for
TO GUIDE YOU
you, just waiting to be lived.
Receiving your Gallant™ or Entrant™
You deserve to feel better, to live cardiac resynchronization therapy
better and have the peace of mind defibrillator (CRT-D) will be an important
that we are here to support you. step in your new journey. We believe a
Together, we can make that life medical condition should not define you or
a reality. get in the way of what’s important to you
and your loved ones.

That’s why we are committed to developing

innovative devices that offer secure,
safe therapy with tools to help you stay
continuously engaged in your treatment.

LET’S GET MOVING

 Y O U R H E A LT H I E R
TOMORROW
S TA R T S T O D AY

PEACE OF MIND
Your Abbott device delivers reliable
treatment you can count on. With
automatic daily checks, the myMerlinPulse
app lets you know that information from
your device is being sent to your clinic
daily. Get the reassurance you need with
secure remote monitoring.

JUST BE YOU
You are more than a patient. Go about
each day as the individual you are. Your
Abbott device is designed to work with the
myMerlinPulse app so that you can have
discreet remote monitoring—you’ll know
but no one else has to.

FREEDOM
Welcome to the health technology that
fits your life. The myMerlinPulse app goes
where you want, when you want— freeing
you to live life on your terms.
YOUR HEALTH IN YOUR HANDS.
Download the myMerlinPulse™ app
for Android‡ or iOS‡ today.
 GOT QUESTIONS?
Visit MyHeartHealth.com for information about
YO U ’R E O N YO U R WAY your new device and the myMerlinPulse app.

There are a number of easy steps you or your loved

ones can take to make sure you’re prepared for success
before, during and after you get your device implanted.

BEFORE YOUR PROCEDURE THE DAY OF YOUR PROCEDURE

This is the most important step. Don’t forget to bring your phone.

Download the myMerlinPulse™ app on your Bring your fully charged smartphone with
smartphone via your phone’s app store. the myMerlinPulse app downloaded on it
with you.

Have your smartphone app store user ID

and password information with you in case it
is needed during the device pairing process.

Either immediately following your procedure,

The myMerlinPulse app
or at a follow-up appointment, someone from
allows you to:
your care team will pair your device with the
Share a transmission with myMerlinPulse app.
your doctor (if requested)

Check your device’s

battery status AFTER YOUR PROCEDURE
View past data You’re on your way to feeling better!
transmissions
The myMerlinPulse app and your device need to
Access help and stay paired. If you get a new smartphone, or need
support resources to do a software update, double-check your app
settings to ensure your app remains connected.
Review any education materials you may have received Visit MyHeartHealth.com for more information
from your doctor about your device or health condition. about pairing your device.
GOT QUESTIONS?
Visit MyHeartHealth.com for information about
your new device and the myMerlinPulse™ app.

Abbott
One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000
Cardiovascular.Abbott
Rx Only
Brief Summary: This product is intended for use by or under the direction of a Physician. Prior to using these devices, please review
the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and
directions for use.
Intended Use: The Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular
antitachycardia pacing and ventricular cardioversion/defibrillation. The CRT-D devices are also intended to resynchronize the right
and left ventricles.
The myMerlinPulse™ mobile application is intended for use by people who have an Abbott Medical implanted heart device and access
to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the
patient’s implanted heart device to the patient’s healthcare provider.
Indications: The CRT-D devices are indicated for automated treatment of life-threatening ventricular arrhythmias. CRT-D devices
are also indicated to treat symptoms in patients who have congestive heart failure with ventricular dyssynchrony.
In addition, CRT-D devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those
patients who are at significant risk of developing atrial tachyarrhythmias.
MR Conditional CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and
according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury,
death or device malfunction.
The myMerlinPulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.
Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from
transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.
The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott
Medical implanted heart devices.
Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following:
Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic
shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth,
Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket,
Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue
reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial
effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct
subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural
damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects
of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction,
inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due
to the following: Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in
defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device
malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate
therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical
or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead
insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator
migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System
failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead
system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure
to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins.
Refer to the User’s Manual for detailed intended use, indications, contraindications, warnings,
precautions and potential adverse events.
No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.
™ Indicates a trademark of the Abbott group of companies.
‡
Indicates a third-party trademark, which is property of its respective owner.
© 2020 Abbott. All Rights Reserved.
MAT-1900099 v4.0 | Item approved for Global use.