Medtronic 97745 User Manual

NEUROMODULATION

257

CONFIDENTIAL

DOCUMENT/RECORD

This document/record is electronically controlled, printed copies are considered uncontrolled.

Identifier Version Author

NDHF1245-121586 4.0 Monica Tuy

Title:

97745 User Manual DRAFT for Agency and Summative Testing

Pages:

(including this page)

APPROVALS

Signed By Responsibility Date/Time (GMT)

Monica Tuy Technical Communications Approver 7/12/2012 5:42:48 PM

Form MEDN-0500 version 3.0

Filename Date Time
UC200xxxxxx EN

4.625″ x 6.0″ inches (117 mm x 152 mm)

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CONTROLLER

Pain therapy user manual for Intellis
97715 and Model 97725 Wireless External
Neurostimulation Systems

™

Model

97745

! USA

  Rx only

M948515A001 Rev X 2013-04

2013

Filename Date Time
UC200xxxxxx EN

4.625″ x 6.0″ inches (117 mm x 152 mm)

Medtronic®, AdaptiveStim®, and SoftStart/Stop® are
trademarks of Medtronic, Inc., registered in the U.S. and
other countries.

Intellis™ is a trademark of Medtronic, Inc.

! USA

FCC Information

The following is communications regulation information
on the Model 97745 Controller.

FCC ID: LF597745

This device complies with Part 15 Rules. Operation is
subject to the following two conditions: (1) this device
may not cause harmful interference and (2) this device
must accept any interference received, including
interference that may cause undesired operation.

IMPORTANT: Changes or modifications to this
product not authorized by Medtronic, Inc., could
void the FCC Certification and negate your authority
to operate this product.

This device complies with Industry Canada license­exempt RSS standard(s). Operation is subject to the
following two conditions: (1) this device may not cause
interference, and (2) this device must accept any
interference, including interference that may cause
undesired operation of the device.

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Label Symbols

Explanation of symbols on products and
packaging. Refer to the appropriate product to
see symbols that apply.

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.

Consult instructions for use

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MR

Magnetic Resonance (MR) Unsafe

Manufacturer

Serial number

PIN No.

REP

EC

PIN number

Authorized representative in the European
community

+XX °C

-XX °C

-XX °F

+XXX °F

Temperature limitation

Non-ionizing electromagnetic radiation

IEC 60601-1/EN60601-1, Type BF
Equipment

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Label Symbols

3

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System meets the applicable Canadian
(CAN/CSA-C22.2 No. 60601-1) and US
(UL 60601-1:2003) electrical safety
standard requirements.

Chinese Standard (SJ/T11364-2006)
Logo: Electronic Information Products
Pollution Control Symbol. (The date in this
logo means the environmental protection
use period of the product.)

Do not dispose of this product in the
unsorted municipal waste stream. Dispose
of this product according to local
regulations. See http://
recycling.medtronic.com for instructions on
proper disposal of this product.

For USA audiences only

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Table of contents

Label Symbols 3

Glossary 12

Introduction 20

1 

How to use this manual 20
Patient guides 22
Patient identification card 25

2  Important therapy

information 28

Purpose of the device 28
Purpose of the neurostimulation system

(indications) 28
Description of your system 29
Therapies that may not be used with the

neurostimulation system
(contraindications) 33

Risks and benefits 33

Risks of surgery 34

Warnings 34
Precautions 43

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Individualization of Treatment 48

3  Recovery and care after

surgery 52

Recovery from surgery 52
Activities 52
When to call your clinician 54
Care schedule 55

4  Using your controller 58

How your controller works 58
Controller screen and keys 59
Home screen 62
Unlocking and locking your

controller 65

Unlocking your controller 65
Locking your controller 69

Turning your stimulation on or off 70

Turning your stimulation on for all pain
areas 70

Turning your stimulation off for all pain
areas 72

How to maintain neurostimulator
batteries 75

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Checking the battery status of the controller
and neurostimulator 75

Changing controller preferences using the
Menu 80

To access the Menu screen 80
Changing the audio and vibration

settings 84
Changing the brightness of the controller

display 86
Changing the date 87
Changing the time 88
Changing the language 90
Changing the number format 91
Viewing information about the controller

and the neurostimulator 92

5  Adjusting your stimulation 96

Introduction 96
Stimulation features 96
Adjusting stimulation settings 96

Programming modes 100

Changing parameter and stimulation
settings 101

Increasing or decreasing a parameter
(intensity, pulse width, or rate) 106

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Adjusting intensity for all pain areas
together 108

Turning stimulation on or off for individual
pain areas 110

Turning cycling on or off 112
Changing a program for individual pain

areas 114

Viewing and changing a group 115
Using AdaptiveStim 117

AdaptiveStim groups and positions 119
Checking your body position 121
Turning AdaptiveStim on or off 124
Making adjustments to AdaptiveStim 125

6  MRI examinations 128

If you have an MRI appointment 128
Responsibilities of the patient in preparing

for the MRI appointment 129
At the MRI appointment 130

Determining if you are in MRI mode 131

Placing your neurostimulation system in
MRI mode for the MRI scan 133

Using your controller to activate MRI
mode 134

Table of contents

Activating MRI mode 135

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Turning stimulation back on after the MRI
scan 139

Visiting your clinician to activate MRI
mode 141

7  Using the recharging system with

the implanted
neurostimulator 146

Recharging the implanted neurostimulator
battery 146

Recharging the neurostimulator
battery 146

To stop recharging the neurostimulator
battery 154

Changing the recharging temperature and
speed 155

Recharging the controller battery
pack 158

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8  Troubleshooting 164

Controller screens 164

Warning screens 165
Alert screens 173
Notification screens 182

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Possible problems and solutions 187

9  Additional information 194

How stimulation works 194
Controlling your stimulation 199

What your clinician controls 199
What you control 199

Possible adverse effects 200
Changes in therapy 200
Possible system complications 200

10  Maintenance and

assistance 204

Accessories 204

Labeling the controller 204
Using the carrying case 205
Replacing the type AA controller

batteries 206
Replacing the controller battery pack 207

Setting up a new controller 208
Cleaning and care 219
Safety and technical checks 221
Battery and controller disposal 221
Neurostimulator disposal 221

Table of contents

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Specifications 222
User assistance 223
Declaration of conformity 224

11  Appendix A: Electromagnetic

interference (EMI) 226

Contraindication 226
Warnings 227
Precautions 238
Notes 242

Index 244

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Glossary

Caution - A statement describing actions that

could result in damage to or improper
functioning of a device.

Clinician - A healthcare professional such as

a doctor or nurse.

Clinician programmer - A device used by a

clinician to send instructions to a
neurostimulator.

Contraindication - A condition or

circumstance when a person should not
have a neurostimulation system.

Controller - A hand-held device that allows

you to turn your neurostimulator on and off
and check your neurostimulator battery. It is
also used to adjust some of the stimulation
settings.

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Diathermy - A medical treatment applied to

the outside of the body that delivers energy
into the body. Three types of energy that can
be used are shortwave, microwave, and
ultrasound. Depending on the power level
used, diathermy devices may or may not
produce heat within the body. This
treatment is typically used to relieve pain,
stiffness and muscle spasms, reduce joint
contractures, reduce swelling and pain after
surgery, and promote wound healing.

Discharged battery - The rechargeable

battery is depleted and should be charged
as soon as possible. When the battery is in
a discharged state, therapy is not
available.

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Elective replacement indicator (ERI) -

Notification that the INS is nearing or has
reached its recommended replacement
date.

Electrode - A metal piece near the tip of the

lead. Electrodes deliver electrical pulses to
the area where your pain signals will be
blocked.

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Electromagnetic interference (EMI) - A

strong field of energy near electrical or
magnetic devices that could prevent the
neurostimulator from functioning properly.

End of service (EOS) - Condition of an ENS

at the time it is no longer able to operate
successfully.

External neurostimulator (ENS) - See

Neurostimulator.

Group - Collection of programs that work

together for a particular effect or area.

Implanted neurostimulator (INS) - See

Neurostimulator.

Indication - The purpose of the

neurostimulation system and the medical
condition for which it may be implanted.

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Intensity - The strength of an electrical

pulse.

Glossary

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Neurostimulation system - The implanted

and external components of the stimulation
system that delivers electrical pulses to
block pain signals as they move to the
brain.

Neurostimulator - The power source of a

neurostimulation system. It contains the
battery and electronics that control the
stimulation you feel. An external
neurostimulator is carried outside the body.
During test stimulation, it is used to
determine whether or not stimulation is
effective. An implanted neurostimulator is
placed inside the body. If stimulation is
effective during test stimulation, the
neurostimulator is implanted.

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Out-of-regulation (OOR) - The

neurostimulator battery is unable to produce
the levels of energy required for the current
stimulation settings.

Pain areas - An area of the body where a

patient feels pain.

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Parameter - One of three stimulation settings

that adjust the electrical pulse: intensity,
pulse width, and rate.

Precaution - See Caution.
Program - Stimulation directed to a specific

pain site.

Pulse width - The length or duration of an

electrical pulse.

Recharger - The component of the

neurostimulation system that is used to
recharge your neurostimulator battery.

SoftStart/Stop - This feature is programmed

by your clinician. When the neurostimulator
is turned on, stimulation will slowly increase
to the programmed intensity. When the
neurostimulator is turned off, stimulation will
slowly decrease.

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Spinal cord - This is your body's information

center. Nerve signals from the entire body
travel to your spinal cord, and then to your
brain.

Glossary

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Stimulation - The delivery of electrical pulses

to the area where pain signals are blocked
as they move to the brain. Stimulation
blocks some pain signals from reaching the
brain.

Stimulation settings - Refers to all the

features assembled to define the stimulation
you feel. The clinician programs all
stimulation. You can adjust some
stimulation settings within clinician-defined
limits.

Test stimulation - The period of time when an

external neurostimulator is used to
determine if stimulation blocks the pain
signals effectively.

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Therapy - Treatment of a disease or condition.

When neurostimulation therapy is
prescribed, a neurostimulation system is
used to deliver stimulation to one or more
pain sites.

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Therapy settings - A specific combination of

intensity, rate, and pulse width parameters
used to control the stimulation delivered by
a neurostimulator.

Warning - A statement describing an action or

situation that could harm the patient.

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1 Introduction

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How to use this manual

Use this manual during test stimulation and
after receiving an implanted neurostimulator.
Ask your clinician to explain anything that is
unclear.

A glossary is provided at the beginning of

•

this manual.
Chapter 1 "Introduction", describes how to

•

use this manual, patient guides you should
receive, and information about the patient
identification card.

Chapter 2 "Important therapy information",

•

describes when you should and should not
use a neurostimulation system, the
neurostimulation system components, and
the risks, benefits, warnings, precautions,
and patient activities related to your
neurostimulation system.

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Chapter 3 "Recovery and care after

•

surgery", provides information about
recovering from surgery, activity and care

Introduction 1

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information, and when to contact your
clinician.

Chapter 4 "Using your controller",

•

describes the controller and how to perform
specific tasks.

Chapter 5 "Adjusting your stimulation",

•

describes how to adjust your stimulation
using your controller.

Chapter 6 "MRI examinations", provides

•

important information about what you
should do if you have an MRI
examination.

Chapter 7 "Using the recharging system

•

with the implanted neurostimulator",
describes how to use the recharging
system to recharge your implanted
neurostimulator battery.

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Chapter 8 "Troubleshooting", describes

•

controller warning, alert, and information
screens and how to solve problems.

Chapter 9 "Additional information",

•

describes how stimulation works, possible

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adverse effects, changes in therapy, and
possible system complications.

Chapter 10 "Maintenance and assistance",

•

describes how to set up a new controller,
care for your controller, and instructions on
using accessories. This chapter also
provides controller specifications and
information about who to call for
assistance.

Chapter 11 "Appendix A: Electromagnetic

•

interference (EMI)", provides information
about electromagnetic interference and
how it may affect your neurostimulation
system.

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Patient guides

Table 1.1 on page 23 describes the
documents you should receive during test
stimulation and after a neurostimulator is
implanted.

Introduction 1

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Table 1.1 Patient guides for test stimulation

and implanted neurostimulation systems

Document ENS

Medtronic Model
97725 Wireless
External
Neurostimulator:
Test Stimulation
Patient Guide

Describes the
goals, activities,
components, and
instructions for
test stimulation.

Medtronic Model
97745 Controller:
Quick Reference
Guide: Provides

instructions for
common
controller tasks.

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a

X

X X

INS

b

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Table 1.1 Patient guides for test stimulation

and implanted neurostimulation systems

Document ENS

Medtronic Model
97755
Recharger:
Recharging
System User
Manual:

Describes the
components of
the recharging
system, including
the rechargeable
battery pack and
power supply.

Patient
Identification
Card: Provides

information about
you, your
implanted
neurostimulator,
and your doctor.

a

External neurostimulator

b

Implanted neurostimulator

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a

INS

X

X

b

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Patient identification card

When you leave the hospital, your doctor will
give you a patient identification card. This card
supplies information about you, your implanted
device, and your doctor. Your identification
card may allow you to bypass security devices.
Carry this card with you at all times and bring
this card with you to all MRI appointments (see
Chapter 6 "MRI examinations").

If you move, change doctors, or lose your card,
contact Medtronic for a replacement card.
Refer to the Medtronic contacts at the end of
this manual.

! USA

A temporary identification card will be
provided at the hospital. After Medtronic
receives your implant registration from the
hospital, you will receive a permanent
identification card.

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2 Important

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Purpose of the device

The Medtronic Model 97745 Controller is
designed to program the following Medtronic
neurostimulators:

Rechargeable

Intellis Model 97715 Implanted

•

Neurostimulator

Nonrechargeable

Model 97725 Wireless External

•

Neurostimulator

Refer to your patient identification card to
determine the model number of your
neurostimulator.

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Purpose of the
neurostimulation system
(indications)

Refer to the indications sheet that is packaged
with the controller for the purpose of the
neurostimulation system and related
information.

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Description of your system

A typical neurostimulation system has
implanted parts that deliver the electrical
pulses to the area where your pain signals are
blocked.

Typically the implanted parts of a
neurostimulation system include (Figure 2.1):
a neurostimulator, 1 or more leads, and 1 or
more extensions (optional).

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Figure 2.1 Implanted parts of a typical

neurostimulation system (spinal cord stimulation

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Neurostimulator

Extensions

Leads

Electrodes

shown).

A typical neurostimulation system also
includes an external controller for controlling
your system. If you have a rechargeable
neurostimulator, your system also includes a
recharging system (Figure 2.2).

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Recharging system
(packaged separately)

Recharger

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Belt

Controller

Power Supply

Battery pack

Figure 2.2 Recharging components of a

rechargeable neurostimulation system.

Neurostimulator – The neurostimulator is the
power source (battery) for your
neurostimulation system. It contains
electronics that generate the electrical pulses.
During test stimulation, an external
neurostimulator is used to determine whether
an implanted neurostimulator is the right
choice for you.

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Note: Your controller refers to the
neurostimulator as the device.

Lead(s) – A lead is a set of thin wires, covered
with a protective coating. A lead has small
metal electrodes near the tip. The electrodes
transmit electrical pulses to the area where
your pain signals are blocked.

Extension(s) – An extension is a set of thin
wires, covered with a protective coating, that
connects the neurostimulator to a lead. Not all
neurostimulation systems include an
extension.

Controller – A controller is a hand-held device
that you use to select and adjust your
stimulation.

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Recharging system – The recharging system

is used to charge the implanted rechargeable
neurostimulator battery. Components included
in the recharging system are: recharger, belt,
battery pack, power supply, and system
carrying case. Refer to the manual packaged
with the recharging system for more

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information about the recharging system
components.

Therapies that may not be
used with the
neurostimulation system
(contraindications)

Diathermy—Inform anyone treating you that

you CANNOT have any shortwave diathermy,
microwave diathermy or therapeutic
ultrasound diathermy (all now referred to as
diathermy) anywhere on your body because
you have an implanted neurostimulation
system. Energy from diathermy can be
transferred through your implanted system,
and can cause tissue damage, resulting in
severe injury or death.

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Risks and benefits

Stimulation has helped thousands of patients
manage their pain and improve their quality of
life. Your neurostimulation system may be
used with other pain treatments. Stimulation

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will not cure your pain. It can, however, reduce
your pain to a tolerable level and allow you to
resume many of your daily activities.

Risks of surgery

Implanting a neurostimulation system has risks
similar to spinal procedures, including spinal
fluid leak, headaches, swelling, bruising,
bleeding, infection, or paralysis.

If you are on anticoagulation therapy you might
be at greater risk for postoperative
complications such as hematomas that could
result in paralysis.

For information about possible adverse
effects, refer to "Possible adverse effects" on
page 200.

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Warnings

Wound contact—DO NOT use the recharger

on an unhealed wound. The recharging system
is not sterile, and contact with the wound may
cause an infection.

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Trial systems (neurostimulation systems
that are not fully implanted)—MRI should not

be prescribed for patients undergoing trial
(test) stimulation or who have any
neurostimulation system components that are
not fully implanted. If an MRI scan is required,
the clinician must explant all trial (test)
stimulation components. MRI has not been
tested on trial (test) stimulation components
and may cause heating of the lead electrodes,
resulting in tissue damage or serious patient
injury.

Electromagnetic interference—

Electromagnetic interference (EMI) is a field of
energy generated by equipment found in the
home, work, medical, or public environments
that is strong enough to interfere with
neurostimulator function. Neurostimulators
include features that provide protection from
EMI. Most electrical devices and magnets
encountered in a normal day are unlikely to
affect the operation of a neurostimulator.
However, sources of strong EMI can result in
the following:

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Serious patient injury or death, resulting

•

from heating of the implanted components

of the neurostimulation system and

damage to surrounding tissue.

System damage, resulting in a loss of or

•

change in symptom control and requiring

additional surgery.

Operational changes to the

•

neurostimulator, that can cause it to turn

on or off, resulting in loss of

neurostimulation and the return of

underlying symptoms.

Unexpected changes in stimulation,

•

causing a momentary increase in

stimulation or intermittent stimulation,

which some patients have described as a

jolting or shocking sensation. Although the

unexpected change in stimulation may feel

uncomfortable, it does not damage the

device or injure a patient directly. In rare

cases, as a result of the unexpected

change in stimulation, patients have fallen

down and been injured.

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Refer to the following table for information
on the effect of EMI on you and your
neurostimulation system. Additional
information and instructions on how to
reduce the risk from EMI are located in
Appendix A of this manual.

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stimulation

Intermittent

increase in

Momentary

stimulation

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off/on

Device turns

Device

damage

patient

Serious

Table 2.1 Potential effects of EMI from devices or procedures

Device or pro-

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cedure

X X X

X X X X

X X X

injury

Bone growth

stimulators

CT scans X

Defibrillation/

cardioversion

Dental drills

and ultrasonic

probesXDiathermy,

therapeutic

Electrocautery X X

Electrolysis X X

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stimulation

Intermittent

increase in

Momentary

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stimulation

off/on

Device turns

(continued)

Device

damage

patient

Serious

Table 2.1 Potential effects of EMI from devices or procedures

Device or pro-

cedure

M948515A001 Rev X 2013-04

X X X

X X

X

injury

Electromagnet-

ic field devices

(eg, arc weld-

ing, power sta-

tions)

High-output ul-

trasonics / lith-

otripsyXHousehold

items

Laser proce-

dures

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Intermittent

Momentary

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stimulation

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Device turns

(continued)

Device

Serious

Table 2.1 Potential effects of EMI from devices or procedures

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Device or pro-

off/on

damage

patient

cedure

X X X X

X X X X X

X X X

injury

Magnetic reso-

nance imaging

(MRI)

Psychothera-

peutic proce-

dures

Radiation ther-

apyXRadio-frequen-

cy (RF) / micro-

wave ablation

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stimulation

Intermittent

increase in

Momentary

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stimulation

off/on

Device turns

(continued)

Device

damage

patient

Serious

Table 2.1 Potential effects of EMI from devices or procedures

Device or pro-

cedure

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X X X

X X

X X X

injury

Theft detector

or security de-

vice

Therapeutic ul-

trasound

Transcutane-

ous electrical

nerve stimula-

tion (TENS)

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Case damage—If the neurostimulator case is
ruptured or pierced due to outside forces,
severe burns could result from exposure to the
battery chemicals.

Neurostimulator interaction with implanted
cardiac devices—When a neurostimulator

and an implanted cardiac device (eg,
pacemaker, defibrillator) are required, the
doctors involved with both devices (eg,
neurologist, neurosurgeon, cardiologist,
cardiac surgeon) should discuss the possible
interactions between the devices before
surgery. To minimize or prevent device
damage or interactions, your doctors should
place the devices on the opposite side of the
body from one another.

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Defibrillation therapy from an implanted

•

defibrillator can damage the

neurostimulator.

The electrical pulses from the

•

neurostimulation system could affect with

the sensing operation from the cardiac

device and result in inappropriate

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doctor should program your
neurostimulator to a bipolar configuration
and a minimum rate of 60 Hz. The cardiac
device should be programmed to bipolar
sensing.

Precautions

System and therapy

Battery charge level—Check battery status

and charge the battery regularly. Battery
capacity will continue to slowly drain, even
when the neurostimulator is off. If the battery
becomes completely discharged, therapy will
be lost.

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Clinician programmer interaction with a
cochlear implant—If you have a cochlear

implant, the external portion of the cochlear
system should be kept as far away as possible
from the clinician programmer or the cochlear
implant should be turned off during
programming to prevent unintended audible
clicks.

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Component compatibility—For proper
therapy, use only Medtronic Neuromodulation
components that are prescribed by your
physician.

Equipment modification—Do not modify this
equipment. Modification of this equipment can
result in damage to the device, causing the
device to malfunction or become unusable.

Patient control devices may affect other
implanted devices—Do not place patient

control devices (eg, patient programmer,
controller, recharger) over another device (eg,
pacemaker, defribrillator, another
neurostimulator). The patient control device
could accidently change the operation of
another device.

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Patient device handling—To avoid

damaging the device, do not immerse it in
liquid; do not clean it with bleach, nail polish
remover, mineral oil, or similar substances;
and do not drop it or mishandle it in a way that
may damage it.

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Patient device use—When operating a
patient control device (eg, external
neurostimulator, patient programmer,
controller, recharging system), use special
care near flammable or explosive
atmospheres. An interaction between the
flammable or explosive atmospheres and the
battery in the device could occur. The
consequences of using a battery-powered
device near flammable or explosive
atmospheres are unknown.

Programmer interaction with other active
implanted devices—If you have a

neurostimulator and another active implanted
device the radio-frequency (RF) signal used to
program either device can reset or reprogram
the other device.

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To verify that inadvertent programming did not
occur, clinicians familiar with each device
should check the programmed settings before
you are sent home from the hospital and after
either device is programmed (or as soon as
possible after these times).

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Contact your doctor immediately if you notice
symptoms that could be related to either
device or to the medical condition treated by
either device.

Patient activities

Activities requiring excessive twisting or
stretching—Avoid activities that may put

undue stress on the implanted components of
your neurostimulation system. Activities that
include sudden, excessive, or repetitive
bending, twisting, bouncing, or stretching can
cause parts of your neurostimulation system to
fracture or migrate. This can result in loss of
stimulation, intermittent stimulation,
stimulation at the fracture site, and additional
surgery. Spinal cord stimulation patients, in
particular, should avoid excessive bending of
the torso.

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Component manipulation (twiddler’s
syndrome)—Do not manipulate or rub your

neurostimulation system through the skin; this
is sometimes called “twiddler's syndrome.”
Manipulation can cause damage to your

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system, lead dislodgement, skin erosion, or
stimulation at the implant site.

Scuba diving or hyperbaric chambers—Do
not dive below 10 meters (33 feet) of water or
enter hyperbaric chambers above 2.0
atmospheres absolute (ATA). Pressures
below 10 meters (33 feet) of water (or above

2.0 ATA) can damage the neurostimulation
system. Before diving or using a hyperbaric
chamber, discuss the effects of high pressure
with your doctor.

Skydiving, skiing, or hiking in the
mountains—High altitudes should not affect

the neurostimulator; however, you should
consider the movements involved in any
planned activity and take precaution to not put
undue stress on your implanted system.
During skydiving, the sudden jerking that
occurs when the parachute opens can
dislodge or fracture the lead, requiring
additional surgery to repair or replace the
lead.

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Unexpected changes in stimulation—

Electromagnetic interference, changes in

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posture, and other activities can cause a
perceived increase in stimulation, which some
patients have described as uncomfortable
stimulation (a jolting or shocking sensation).
You should reduce your intensity to the lowest
setting and turn off your neurostimulator before
engaging in activities that could be unsafe for
you or others if you received an unexpected jolt
or shock (eg, driving, operating power tools).
Discuss these activities with your doctor.

Individualization of Treatment

Patient management—Best results are

achieved when you are fully informed about
the therapy risks and benefits, surgical
procedure, follow-up requirements, and self­care responsibilities. Maximum benefits from
the neurostimulation system require long-term
postsurgical management.

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Patient selection—The neurostimulation

system should not be implanted if:

your symptoms are not of physiological

•

origin,

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you are not an appropriate candidate for

•

surgery,
you cannot properly operate the system, or

•

you do not receive satisfactory results from

•

test stimulation.

Use in specific populations—The safety and
effectiveness of this therapy has not been
established for the following:

Pregnancy, unborn fetus, or delivery

•

Pediatric use (patients under the age of 18)

•

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