St. Jude Medical 3875 User manual

St. Jude Medical™ Patient
Controller
For Deep Brain Stimulation Systems
Model 3875
User's Guide

CAUTION: Federal (USA) law restricts this device to sale by or on the order of
a physician.
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k of, or
licensed to, St.
Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL
and the nine
-squares symbol are trademarks and service marks of St. Jude
Medical, LLC and its related companies.
Pat.
http://patents.sjm.com
©
2017 St. Jude Medical, LLC. All Rights Reserved.

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Contents
About This Guide......................................................1
Symbols and Definitions ......................................1
Terms Used in This Document ............................6
Prescription and Safety Information ..........................6
Intended Use ......................................................6
Indications for Use ..............................................7
Contraindications ................................................7
Warnings.............................................................8
Precautions.......................................................14
Adverse Effects .................................................22
Patient Expectations ..........................................27
Product Description................................................29
About Your System............................................30
Overview of the Patient Controller ......................31
Items You Will Receive ......................................34
Your Personal Identification Card.......................34
Directions for Use...................................................35
Start-up Screen .................................................35
Overview of the Therapy Screen ........................36
Starting and Stopping Stimulation......................40
Program Mode ..................................................42
Using the Surgery Mode Feature .......................43
Viewing and Selecting a Program.......................47
Adjusting Strength.............................................50
System Information ...........................................52
Maintaining the Generator and Patient Controller ....54
Checking the Generator Battery Status ..............54

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Checking the Patient Controller Battery Status ...55
Caring for the Patient Controller.........................55
Protecting Access to the Patient Controller.........56
Troubleshooting......................................................56
Technical Support ..................................................68
Appendix A: Downloading the Patient Controller
App .....................................................................68
Appendix B: Pairing the Patient Controller to the
Generator.............................................................70
Appendix C: Regulatory Statements ........................71
Statement of FCC Compliance ...........................71
Statement of Compliance With License-Exempt
RSS Standard (Canada) ..................................72
Declaration of Conformity (Industry Canada)
Notice to Users of Radio and Television ..........73
Identification Information for Product
Registration ....................................................73
Product Classification Statement (CISPR 11,
Class B)..........................................................73
Wireless Technology Information .......................74
Radio Transmitter, Cables, Transducers ............75
Quality of Service for Wireless Technology .........76
Appendix D: Electromagnetic Compatibility
Guidelines............................................................79
Radio Frequency Information ............................89

1
About This Guide
This guide explains how to use the St. Jude Medical™
Patient Controller application (Model 3875) with your
neurostimulation system. If you have any questions
about your system, contact Technical Support.
Symbols and Definitions
The following symbols may be used in this document
and on some of the products and packaging:
NOTE: For symbols and definitions for the
patient controller, refer to the Apple™
manual available at
http://www.apple.com/support/ipodtouch/; or
on the patient controller Home screen, tap
Settings > General > About > Legal >
Regulatory. (Apple™ is a trademark of Apple
Inc.)
Table 1. Symbols and definitions
Symbol
Definition
Caution, consult accompanying
documents

2
Table 1. Symbols and definitions
Symbol
Definition
Consult this document for important
safety-related information (This
symbol is blue and white on the
device.)
Consult instructions for use
Device contains a type BF applied
part to protect you from shock. The
device is internally powered and is
intended for continuous operation.
Device contains a radio-frequency
(RF) transmitter, which may cause RF
interference with other devices near
this device.
Magnetic Resonance (MR) Unsafe,
an item poses unacceptable risks to
the patient, medical staff, or other
persons within an MR environment
Expiration date
Date of manufacture
Catalog number

3
Table 1. Symbols and definitions
Symbol
Definition
Manufacturing facility
Manufacturer
Do not use if the product sterilization
barrier or its packaging is
compromised
Contents quantity
Batch code
Prescription use only

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Table 1. Symbols and definitions
Symbol
Definition
This product shall not be treated as
household waste. Instead it is the
user’s responsibility to return this
product to St. Jude Medical for
reprocessing.
By ensuring that this product is
disposed of properly, you will help
prevent potential negative
consequences for the environment
and human health, which could be
caused by inappropriate waste
handling of this product. The
recycling of materials will help to
conserve natural resources.
For more information about how to
return this product for recycling,
please contact St. Jude Medical.
Authorized European representative
Australian Sponsor

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Table 1. Symbols and definitions
Symbol
Definition
European conformity, affixed in
accordance with the relevant
provisions of AIMD directive
90/385/EEC. Hereby, St. Jude
Medical declares that this device is in
compliance with the essential
requirements and other relevant
provisions of this directive.
Australian Communications and
Media Authority (ACMA) and New
Zealand Radio Spectrum
Management (RSM) Regulatory
Compliance Mark (RCM)
This equipment is certified for type
certification pursuant of Article 38-24
of the Japan Radio Law

6
Terms Used in This Document
This section contains definitions of some of the terms
used in this document.
Program. A combination of stimulation parameters
that are set to get a desired therapeutic effect.
Stimulation parameter. A setting that is part of a
complete program.
Prescription and Safety Information
Read this section to gather important prescription and
safety information.
Intended Use
The St. Jude Medical™ neurostimulation system is
designed to deliver electrical stimulation to targets in
the brain. The St. Jude Medical™ Patient Controller
app is intended to be used as part of the system to
help the patient manage prescribed stimulation
programs.

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Indications for Use
The St. Jude Medical™ deep brain stimulation system
is indicated for the following conditions:
Bilateral stimulation of the subthalamic nucleus
(STN) as an adjunctive therapy to reduce some of
the symptoms of advanced levodopa-responsive
Parkinson’s disease that are not adequately
controlled by medications.
Unilateral or bilateral stimulation of the ventral
intermediate nucleus (VIM) of the thalamus for
the suppression of disabling upper extremity
tremor in adult essential tremor patients whose
tremor is not adequately controlled by
medications and where the tremor constitutes a
significant functional disability.
Contraindications
This system is contraindicated for patients who meet
the following criteria:
Are unable to operate the system
Have unsuccessful test stimulation
The following procedures are contraindicated for
patients with a deep brain stimulation system. Advise
patients to inform their healthcare professional that
they cannot undergo the following procedures:
Diathermy (short-wave diathermy, microwave
diathermy, or therapeutic ultrasound diathermy)

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Electroshock therapy and transcranial magnetic
stimulation (TMS)
Warnings
The following warnings apply to this neurostimulation
system.
NOTE: For non-therapy related warnings
regarding the St. Jude Medical™ Patient
Controller, refer to the Apple™ manual
available at
http://www.apple.com/support/ipodtouch/.
System Warnings
Pregnancy and nursing. Do not use the
neurostimulation system if you are pregnant or
nursing.
Magnetic resonance imaging (MRI). Do not perform
an MRI on a patient with any implanted
neurostimulator or lead (or any portion of a lead).
Even if the neurostimulator has been removed, the
patient should not have an MRI if any part of a lead or
the cranial prosthesis is still implanted. The
neurostimulation system is MR unsafe. Testing has
not been performed to define conditions of use to
ensure safety of the neurostimulation system in an
MR environment.
High stimulation outputs and charge density limits.
Avoid excessive stimulation. A risk of brain tissue
damage exists with parameter settings using high
amplitudes and wide pulse widths. High amplitudes

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and wide pulse widths should only be programmed
with due consideration of the warnings concerning
charge densities. The system can be programmed to
use parameter settings outside the range of those
used in the clinical studies. If the programming of
stimulation parameters exceeds the charge density
limit of 30 μC/cm2, a screen will appear warning you
that the charge density is too high. Charge density can
be reduced by lowering the stimulation amplitude or
pulse width. For more information, see the clinician
programmer manual.
Higher amplitudes and wider pulse widths may
indicate a system problem or a suboptimal lead
placement. Stimulation at high outputs may cause
unpleasant sensations or motor disturbances or may
render the patient incapable of controlling the patient
controller. If unpleasant sensations occur, the device
should be turned off immediately using the patient
magnet.
Risk of depression, suicidal ideations, and suicide.
Depression, suicidal ideation, and suicide have been
reported in patients receiving deep brain stimulation
therapy for movement disorders, although no direct
cause and effect relationship have been established.
Note the presence of any of the following symptoms
and discuss them with your clinician: depression,
suicidal thoughts, or behaviors, changes in mood, and

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impulse control. Sustained follow-up and support with
your clinician, caregivers and family members is very
important.
Operation of machinery and equipment. Do not
operate potentially dangerous machinery, power tools,
or vehicles or engage in any activity that could be
unsafe if your symptoms were to unexpectedly return.
Device components. The use of components not
approved for use by St. Jude Medical may result in
damage to the system and increased risk to the
patient.
Electrosurgery devices. Electrosurgery devices may
harm you or damage your neurostimulation system. If
you need to receive a procedure using an
electrosurgery device, place your generator in Surgery
Mode. Your physician may only use bipolar
electrosurgery devices and they should keep the
device as far away from your neurostimulation system
as possible. Additionally, they must confirm the
neurostimulation system is functioning correctly after
your procedure.
Radiofrequency or microwave ablation. Careful
consideration should be used before using
radiofrequency (RF) or microwave ablation in patients
who have an implanted neurostimulation system since
safety has not been established. Induced electrical
currents may cause heating, especially at the lead
electrode site, resulting in tissue damage.

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Implanted cardiac devices. Physicians need to be
aware of the risk and possible interaction between a
neurostimulation system and an implanted cardiac
system, such as a pacemaker or defibrillator.
Electrical pulses from a neurostimulation system may
interact with the sensing operation of an implanted
cardiac system, causing the cardiac system to
respond inappropriately. To minimize or prevent the
implanted cardiac system from sensing the output of
the neurostimulation system, (1) maximize the
distance between the implanted systems; (2) verify
that the neurostimulation system is not interfering with
the functions of the implanted cardiac system; and (3)
avoid programming either device in a unipolar mode
(using the device’s can as an anode) or using
neurostimulation system settings that interfere with
the function of the implantable cardiac system.
Other active implanted devices. The
neurostimulation system may interfere with the normal
operation of another active implanted device, such as
a pacemaker, defibrillator, or another type of
neurostimulator. Conversely, the other active
implanted device may interfere with operation of the
neurostimulation system.
Case damage. If the case of the implantable pulse
generator (IPG) is pierced or ruptured, severe burns
could result from exposure to battery chemicals.

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Cremation. The IPG should be explanted before
cremation because the IPG could explode. Return the
explanted IPG to St. Jude Medical.
Low frequencies. Stimulation frequencies at less than
30 Hz may cause tremor to be driven (meaning that
tremor occurs at the same frequency as the
programmed frequency). For this reason,
programming at frequencies less than 30 Hz is not
recommended.
Return of symptoms and rebound effect. The
abrupt cessation of stimulation for any reason will
probably cause disease symptoms to return. In some
cases, symptoms may return with a greater intensity
than what a patient experienced before system
implantation (rebound effect). In rare cases, this can
create a medical emergency.
Emergency procedures. Designate a representative
(family member or close friend) to notify any
emergency medical personnel of your implanted
neurostimulation system if emergency care is
required. You will receive an identification card to
carry that will inform emergency medical personnel of
your implanted system. Use caution when undergoing
any procedure that could include radiofrequency (RF)
or microwave ablation, defibrillation, or cardioversion.

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Device Warnings
Explosive or flammable gases. Do not use the device
in an environment where explosive or flammable gas
fumes or vapors are present. Operating the device
could cause it to ignite, causing severe burns, injury,
or death.
Interference with other devices. This equipment can
radiate radiofrequency (RF) energy that may interfere
with other electronic devices, including other active
implanted devices. Avoid placing equipment
components directly over other electronic devices. To
correct the effect of interference with other devices,
turn off the equipment or increase the distance
between the equipment and the device being
affected.
Application modification. To prevent unintended
stimulation, do not modify the operating system in any
way. Do not use the application if the operating
system is compromised (i.e., jailbroken).
Strangulation. The cords in this system pose a
strangulation risk. To avoid strangulation, be careful
when using cords and keep cords out of the reach of
children.

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Precautions
The following precautions apply to this
neurostimulation system.
NOTE: For nontherapy related precautions for
the St. Jude Medical™ Patient Controller,
refer to the Apple™ manual available at
http://www.apple.com/support/ipodtouch/.
General Precautions
Infection. Follow proper infection control procedures.
Infections may require that the device be explanted.
Electromagnetic interference (EMI). Some
equipment in home, work, medical, and public
environments can generate EMI that is strong enough
to interfere with the operation of a neurostimulation
system or damage system components. Avoid getting
too close to these types of EMI sources, which include
the following examples: commercial electrical
equipment (such as arc welders and induction
furnaces), communication equipment (such as
microwave transmitters and high-power amateur
transmitters), high-voltage power lines, radio-
frequency identification (RFID) devices, and some
medical procedures (such as therapeutic radiation
and electromagnetic lithotripsy).
Security, antitheft, and radiofrequency identification
(RFID) devices. Some antitheft devices, such as those
used at entrances or exits of department stores,
libraries, and other public establishments, and airport

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security screening devices may affect stimulation.
Additionally, RFID devices, which are often used to
read identification badges, as well as some tag
deactivation devices, such as those used at payment
counters at stores and loan desks at libraries, may
also affect stimulation. Use caution when approaching
such a device and request help to bypass the device.
If you must go through or near a gate or doorway
containing this type of device, move quickly and then
check your IPG to determine if it is turned on or off.
Unauthorized changes to stimulation parameters.
Do not make unauthorized changes to physician-
established stimulation parameters.
Damage to shallow implants. Falling and other
traumatic accidents can damage shallowly implanted
components such as the leads and extensions.
Long-term safety and effectiveness. The long-term
safety and effectiveness of this neurostimulation
system has not been established beyond 5 years.
Safety and effectiveness has not been established for
patients with neurological disease other than
Parkinson’s disease or essential tremor, previous
surgical ablation procedures, dementia,
coagulopathies, or moderate to severe depression;
patients under 22 years; implantation in targets other
than STN for Parkinson's disease and VIM for
essential tremor; patients with an active implantable
device; patients requiring MRI.

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Handling and Implantation
Component manipulation. Do not rub or press on
implanted components through the skin. This may
cause the leads to move leading to stimulation at the
implant site, IPG inversion leading to the inability to
communicate with the device, or skin erosion that can
lead to another surgical procedure or possible
infection.
Abandoned leads. The long-term safety associated
with multiple implants, leads left in place without use,
replacement of leads, multiple implants into the target
structure, and lead explant is unknown.
Hospital and Medical Environments
Medical tests and procedures. Before undergoing
medical tests or procedures (such as therapeutic
radiation or electrolysis), contact your physician to
determine if the procedure will cause you injury or
damage your neurostimulation system. Specifically,
you should be aware that medical devices such as
electrohydraulic lithotriptors, therapeutic X rays,
computerized tomography (CT) scans, cobalt
machines, and linear accelerators may cause damage
to the electronic circuitry of an implanted
neurostimulation system.
Electrical medical treatment. In the case that a
medical treatment is administered where an electrical
current is passed through the body from an external
source, first deactivate the IPG by setting all