Medtronic MEDSIMPLANT1 User Manual

REVEAL LINQ™

INSERTABLE CARDIAC MONITOR AND PATIENT ASSISTANT

Patient Manual

Caution:

order of a physician.

Fede ral law (USA) restricts this device to sale by or on the

The following list includes trademarks or registered trademarks of Medtronic in the
United S ta tes and possibly in other c ountrie s. All oth er tradem arks are t he prope rty
of their respective owners.

Medtronic, Medtronic CareLink, MyCareLink, Reveal, Reveal LINQ, TUNA.

How to contact Medtronic

Contact us by phone

Our experienced Patient Services group is available to answer any
questions or concerns you may have about your heart device. To
speak directly with a Patient Services Specialist, call
1-800-551-5544. Our staff is available Monday through Friday
from 8:00 AM to 5:00 PM (Central Time).

Contact us online

Medtronic is dedicated to providing you with the most up-to-date
information available about your Medtronic heart device. Website
information is available 24 hours a day.

•

Medtronic website: www.medtronic.com

•

Patient Services website: www.medtronic.com/rhythms

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If you would like to submit questions, suggestions, or requests to
us online, you can use the online form provided at
www.medtronic.com/contact-us.

Contact us by mail or fax

Medtronic Inc.
Patient Services Department
Mail Stop MVS 14
8200 Coral Sea Street NE
Mounds View, MN 55112
Fax: [phone]

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Contents

Chapter 1 Overview 7

Chapter 2 The insertion procedure, recovery, and follow-up 15

Chapter 3 Using your Patient Assistant 21

Chapter 4 Living life with your cardiac monitor 41

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6

Overview

1

Your doctor should be your first source of information regarding your
health. This manual addresses many of the questions you or your family
may have about your cardiac monitor. If you have questions that are not
covered in this manual or you want more in-depth information about
your cardiac monitor, contact Medtronic (see page 3).

Overview of the Medtronic Reveal LINQ system

Your doctor has recommended a Medtronic Reveal LINQ insertable
cardiac monitor system. The Reveal LINQ system allows your heart’s
electrical activity to be continuously monitored while you are away from
your hospital or clinic. The system consists of your inserted cardiac
monitor, the MyCareLink Patient Monitor that you generally keep by
your bedside for automatic daily monitoring, and a handheld device
called the Patient Assistant that you carry with you to easily record
information about any heart-related events you experience. Table 1
provides an overview of the Reveal LINQ system.

English 7

Table 1. Overview of how the Reveal LINQ system is used to monitor
and diagnose symptoms

The Reveal LINQ cardiac monitor senses your
heart rate continuously and, as programmed
by your doctor, automatically stores heart­related events.

If you experience a symptom such as dizziness,
fainting, or palpitations, then during or very
soon after experiencing a symptom, you press
the button on the Patient Assistant and hold it
over your cardiac monitor.

Your heart doctor can monitor you by having
the data from your cardiac monitor transmitted
automatically to your clinic daily through your
bedside MyCareLink Patient Monitor, if your
doctor prescribed one.

8 English Chapter 1

Table 1. Overview of how the Reveal LINQ system is used to monitor
and diagnose symptoms (continued)

Your doctor can also monitor you through in­office clinic appointments. Your doctor will
make sure your cardiac monitor is working
correctly and review the data saved in the
cardiac monitor.

Next are additional details on the Reveal LINQ system components.

Cardiac monitor

The Reveal LINQ cardiac monitor is inserted under your skin, generally
in your left chest area. The cardiac monitor, shown above, is only about

1.8 in (4.5 cm) long, is less than 0.3 in (0.7 cm) wide, and it is very thin. It
will likely be minimally noticeable under your skin.

Overview 9

While you go about your daily activities, the cardiac monitor keeps track
of your heart’s electrical activity. Recordings are stored based on your
doctor’s programmed settings. Your doctor can use these recordings and
information from you about your symptoms to help monitor, diagnose,
and manage heart rhythm disturbances (called arrhythmias), or to
determine if your symptoms are related to something else. Your
symptoms may include syncope (fainting), light-headedness, dizziness,
and palpitations (sensations of an unduly rapid or irregular heartbeat).

The cardiac monitor records an electrocardiogram (ECG), which is a
pattern of your heart’s electrical activity. Your doctor can review the
stored ECG, which helps to show if your heart’s rhythm is too slow, too
fast, irregular, or normal.

There are two ways the cardiac monitor stores this ECG information for
your doctor to review later:

• ECG recordings stored when you or a caregiver uses the Patient
Assistant.

• Automatic ECG recordings based on how your doctor has
programmed the cardiac monitor. Your doctor can tell you how many
recordings your cardiac monitor is programmed to store.

10 English Chapter 1

Talk with your heart doctor about when you should have the data from
your cardiac monitor read.

Patient Assistant

The Patient Assistant model 9538 is a small, handheld device about the
size of a pager. Carry it with you at all times so that you have it
whenever you experience symptoms. As instructed by your doctor, you
use it to record (mark) heart rhythm information in your inserted
cardiac monitor while, or just after, having symptoms. Data is stored in
the cardiac monitor, not the Patient Assistant. For detailed instructions,
see “Using your Patient Assistant” on page 21.

Overview 11

MyCareLink Patient Monitor

The MyCareLink Patient Monitor is an electronic device that makes it
easy and automatic for your doctor to obtain information that is
recorded in your cardiac monitor. The MyCareLink Patient Monitor
gathers this information to allow your doctor to manage your care and
determine if any of your symptoms are related to your heart rhythm.

Once you have set up the MyCareLink Patient Monitor and completed
an initial manual transmission, the MyCareLink Patient Monitor is
designed to automatically gather information daily from your heart.
This automatic wireless communication between your cardiac monitor
and the MyCareLink Patient Monitor takes place at times scheduled by
your clinic, typically while you sleep. For more information, see
“Remote monitoring with the Medtronic CareLink Service and
MyCareLink Patient Monitor” on page 17.

12 English Chapter 1

Frequently asked questions

Here are some answers to questions that new patients frequently ask.
Contact your doctor or Medtronic if you have additional questions.

How long will I have my cardiac monitor inserted?

Your doctor will decide how long you need the cardiac monitor. The
battery is designed to last approximately 3 years.

What if my symptoms are not related to my heart rhythm?

Then your doctor looks for other causes. For example, syncope
(commonly called fainting) is sometimes hard to diagnose because
fainting may be related to fatigue, stress, hormonal imbalance,
neurological abnormalities, or other causes. If you do not have heart
rhythm problems, your doctor can focus on other potential causes or
refer you to another doctor.

Why do I need a device identification card?

Your Medtronic device identification (ID) card has information about
you, your doctor, and your cardiac monitor in case you have a medical
emergency or have a medical question. An ID card is attached to your
Patient Assistant Quick Reference Card. Carry it with you at all times.

Overview 13

What if I am scheduled for a medical procedure?

Before any medical procedure, always show your Medtronic device ID
card so medical personnel are aware that you have an implanted
medical device. For more information about medical procedures that
require precautions, such as magnetic resonance imaging (MRI) scans,
see “Medical procedure warnings and precautions” on page 51.

What if I need to travel?

When you travel, continue to use your Patient Assistant and
MyCareLink Patient Monitor as instructed and always carry your
cardiac monitor ID card. For information on passing through security
systems such as at the airport, see “Security systems” on page 50.
Consult with your cardiac monitor doctor before your travel for an
extended period of time. Your doctor can make sure your cardiac
monitor transmissions are adjusted for time zone differences, if
necessary, before and after you travel. To contact Medtronic, see page 3
or the back cover of this manual for contact information worldwide.

Are there things my family and friends should know?

They should learn how to use the Patient Assistant so that they can assist
you, if needed (see “Using your Patient Assistant” on page 21).

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The insertion procedure,

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The insertion procedure

The insertion procedure for your cardiac monitor does not require major
surgery. This simple procedure can generally be done within 15 to
20 minutes. Here are the general steps of an insertion procedure:

1. The incision is made. Local anesthesia is used to numb the incision

site. You can compare it to the numbing of your gums in your
dentist’s office. Your doctor will make a small incision in the skin at a
location that is suitable for your situation.

2. The cardiac monitor is inserted. The cardiac monitor is inserted

under the skin. Your doctor tests the cardiac monitor to confirm that
it is operating correctly.

3. The incision is closed. Your doctor will close the incision and explain

how to care for your incision area.

recovery, and follow-up

English 15

Potential risks after the insertion procedure

Caution: Contact your doctor or nurse if you notice any swelling,
warmth, or drainage around your incision or if you develop a fever
while your incision is healing.

• As with any kind of surgery, there is the potential risk of infection.

• Tell your other doctors that you have a cardiac monitor. They may
choose to prescribe antibiotics for you to take before and after any
surgery to prevent infection.

Recovering after your procedure

As you recover, follow your doctor’s suggestions about resuming
normal activities. You may see or feel a slight bulge under your skin
where the cardiac monitor is located.

When you are driving or riding in a vehicle, the seat belt strap that fits
over your shoulder may feel uncomfortable. You can place a soft towel
between the shoulder seat belt strap and your insertion site to cushion
the area during the first few weeks after the insertion procedure. In any
case, seat belts should be worn at all times.

16 English Chapter 2

Follow-up appointments

Before you leave the hospital, your doctor will tell you if you need to
schedule a follow-up appointment. A follow-up appointment usually
takes the same amount of time as a regular doctor’s appointment.

A follow-up appointment serves the following purposes:

• Assess your general medical condition

• Check the operation of your cardiac monitor

• Review the information saved by your cardiac monitor

• Adjust your cardiac monitor settings, if necessary

• Review instructions on using the Patient Assistant (see page 21)

Remote monitoring with the Medtronic CareLink Service and MyCareLink Patient Monitor

The Medtronic CareLink Service is convenient. You do not have to leave
your home for most follow-up appointments. The service allows you to
send your cardiac monitor information over a cellular line to your clinic
at a time set up by your doctor, instead of visiting your clinic in person.
If the cardiac monitor information that is sent to your doctor indicates

The insertion procedure, recovery, and follow-u p 17