St. Jude Medical Proclaim DRG 3664 User manual

Proclaim™DRG Implantable Pulse Generator
Model 3664
Clinician's Manual

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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
Prescription and Safety Information ....................................................................................... 1
Intended Use...................................................................................................................... 1
Indications for Use............................................................................................................... 1
Contraindications................................................................................................................. 1
MRI Safety Information......................................................................................................... 2
Warnings ............................................................................................................................ 2
Precautions......................................................................................................................... 8
Adverse Effects.................................................................................................................. 14
System Overview................................................................................................................... 16
Product Description.............................................................................................................. 18
Package Contents.............................................................................................................. 19
Identifying the IPG............................................................................................................. 19
Directions for Use................................................................................................................. 20
Creating an IPG Pocket....................................................................................................... 21
Connecting a Lead or Extension to the IPG............................................................................ 22
Implanting the IPG............................................................................................................. 26
Replacing the IPG.............................................................................................................. 28

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Disposing of Explanted Components..................................................................................... 29
Checking the Status of the IPG Battery ................................................................................ 29
Technical Support ................................................................................................................ 30
Appendix A: Product Specifications ..................................................................................... 30
Storage Specification s ........................................................................................................ 31
Product Materials............................................................................................................... 31
IPG Specifications.............................................................................................................. 32
Appendix B: System Com ponents and Accessories ............................................................. 34
IPGs................................................................................................................................. 34
Programme rs and Controllers .............................................................................................. 34
Leads and Extensions......................................................................................................... 35
Trial System ...................................................................................................................... 36
Appendix C: Regulatory Statements ..................................................................................... 36
Disposal Guidelines for Battery-Powered Devices................................................................... 36
Statement of FCC Compliance............................................................................................. 37
Statement of Compliance With License-Exempt RSS Standard (Canada)................................... 38
Identification Information for Product Registration.................................................................. 38
Wireless Technology Information.......................................................................................... 39
Radio Transmitter, Cables, Transducers ............................................................................... 40
Quality of Service for Wireless Technology............................................................................. 41

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Appendix D: Sy mbols and Definitions ................................................................................... 43
Additional Symbols for Product Labels.................................................................................. 47
Appendix E: CE Mark Date ................................................................................................... 48

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Prescription and Safety Information
Read this section to gather important prescription and safety information.
Intended Use
This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures.
The system is intended to be used with leads and associated extensions that are compatible with the
system.
Indications for Use
This neurostimulation system is indicated for the management of chronic, intractable pain.
Contraindications
This system is contraindicated for patients who are
Unable to operate the system
Poor surgical risks
Pregnant
Under the age of 18

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MRI Safety Information
Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices
may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning
are met. For more information about MR Conditional neurostimulation components and systems,
including equipment settings, scanning procedures, and a complete listing of conditionally approved
components, refer to the MRI procedures clinician's manual for neurostimulation systems (available
online at manuals.sjm.com). For more information about MR Conditional products, visit the St. Jude
Medical product information page at sjmprofessional.com/MRI.
Warnings
The following warnings apply to this neurostimulation system.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and
nursing have not been established.
Pediatric use. The safety and effectiveness of neurostimulation for pediatric use have not been
established.
External defibrillators. Safety for use of external defibrillator discharges on a patient receiving
neurostimulation has not been established.External defibrillation can cause induced currents in the
lead-extension portion of the neurostimulation system. After defibrillation, confirm the neurostimulation
system is still working.

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Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make
up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the
requirements for the implanted components and for scanning are met. A physician can help determine
if a patient is eligible to receive an MRI scan by following the requirements provided by St. Jude
Medical. Physicians should also discuss any risks of MRI with patients.
Patients without an MR Conditionalneurostimulation system should not be subjected to MRI because
the electromagnetic field generated by an MRI may damage the device electronics, cause heating at the
lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock
the patient.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound
diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system.
Energy from diathermy can be transferred through the implanted system and cause tissue damage at
the location of the implanted electrodes, resulting in severe injury or death.
Diathermy is further prohibited because it may also damage the neurostimulation system components.
This damage could result in loss of therapy, requiring additional surgery for system implantation and
replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation
system is turned on or off. Advise patients to inform their healthcare professional that they should not
be exposed to diathermy treatment.
Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use
monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an

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electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician
programmer app. Confirm the neurostimulation system is functioning correctly after the procedure.
During implant procedures, if electrosurgery devices must be used, take the following actions:
Use bipolar electrosurgery only.
Complete any electrosurgery procedures before connecting the leads or extensions to the
neurostimulator.
Keep the current paths from the electrosurgery device as far from the neurostimulation system as
possible.
Set the electrosurgery device to the lowest possible energy setting.
Confirm that the neurostimulation system is functioning correctly during the implant procedure
and before closing the neurostimulator pocket.
Implanted cardiac systems. 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

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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.
Emergency procedures. Instruct patients to designate a representative (family member or close friend)
to notify any emergency medical personnel of their implanted neurostimulation system if emergency
care is required. Patients will receive an identification card to carry with them that will inform
emergency medical personnel of their implanted system. Advise patients to use caution when
undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation,
or cardioversion.
Routine medical procedures. Advise patients to avoid dental procedures, diathermy, electrolysis,
diagnostic ultrasound, static field therapeutic magnets, diagnostic X rays, and high-output ultrasonic
lithotripsy. These procedures may cause interference that can affect the operation of the
neurostimulator or damage components of the system, causing patient harm. If patients with a
neurostimulator receive any medical treatment in which an electrical current is passed through their
body from an external source, either the device should first be deactivated or care should be taken to
monitor the functioning of the neurostimulator during the initial stages of treatment.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical
damage to an implanted neurostimulation system if used directly over the implanted system.
Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted
neurostimulation system, although no testing has been done and no definite information on radiation
effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and

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linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded
with lead. Damage to the system may not be immediately detectable.
Restricted areas. Warn patients to seek medical guidance before entering environments that could
adversely affect the operation of the implanted device, including areas protected by a warning notice
preventing entry by patients fitted with a pacemaker.
Component manipulation by patients. The patient must be instructed to not rub or exert pressure on
implanted components through the skin as this may cause lead dislodgement 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.
Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects
over 2 kg (5 lb) for at least six weeks after implantation. These activities may cause lead movement,
resulting in understimulation or overstimulation for the patient. Excessive lead migration may require
reoperation to replace the leads.
Scuba diving and hyperbaric chambers. Instruct patients to avoid scuba diving and entering
hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage
the neurostimulation system.
Operation of machines, equipment, and vehicles. In the clinical experience with this device, patients
have experienced few effects when moving from lying down to sitting up. Therefore, it is unlikely
patientswill need to adjust stimulation when changing positions or moving. However, advise patients
who feel uncomfortable paresthesia during postural changes that they should not operate potentially

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dangerous equipment such as power tools, automobiles, or other motor vehicles. These patients should
not climb ladders or participate in activities where postural changes or abrupt movements could alter
the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles
or injure others.
Explosive and flammable gases. Do not use a clinician programmer or patient controller in an
environment where explosive or flammable gas fumes or vapors are present. The operation of these
devices could cause them to ignite, causing severe burns, injury, or death.
Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to avoid
damage. Advise patients to not use their device when engaging in activities that might cause it to get
wet, such as swimming or bathing.
Device components. The use of components not approved for use by St. Jude Medical with this system
may result in damage to the system and increased risk to the patient.
Device modification. The equipment is not serviceable by the customer. To prevent injury or damage to
the system, do not modify the equipment. If needed, return the equipment to St. Jude Medical for
service.
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).
Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could
result from exposure to battery chemicals.

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IPG disposal. Return all explanted IPGs to St. Jude Medical for safe disposal. IPGs contain batteries as
well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because
explosion or fire may result.
Product materials. Neurostimulation systems have materials that come in contact or may come in
contact with tissue. A physician should determine whether or not a patient may have an allergic reaction
to these materials before the system is implanted.
Precautions
The following precautions apply to this neurostimulation system.
General Precautions
Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of
chronic pain syndromes and have undergone surgical and device implantation training.
Patient selection. It is extremely important to select patients appropriately for neurostimulation.
Thorough psychiatric screening should be performed. Patients should not be dependent on drugsand
should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures. Infections related to system implantation might
require that the device be explanted.

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Implantation of multiple leads. If multiple leads or extensions are implanted, the leads and extensions
should be routed in close proximity. Nonadjacent leads and extensions have the possibility of creating a
conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.
High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor
disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations
occur, the device should be turned off immediately.
Postural changes. In the clinical experience with this device, patients have experienced few effects
when moving from lying down to sitting up. Therefore, it is unlikely patients will need to adjust
stimulation when changing positions or moving. However, some patients may experience a decrease or
increase in the perceived level of stimulation. Perception of higher levels of stimulation has been
described by some patients as uncomfortable, painful, or jolting. Advise patients who experience these
types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme
posture changes or abrupt movements such as stretching, lifting their arms over their heads, or
exercising. If unpleasant sensations occur, the IPG should be turned off immediately.
Sterilization and Storage
Single-use, sterile device. The implanted components of this neurostimulation system are intended for
a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas
before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field.
Do not resterilize or reimplant an explanted system for any reason.

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Storage environment. Store components and their packaging where they will not come in contact with
liquids of any kind.
Handling and Implementation
Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the
system if the use-before date has expired.
Package or component damage. Before opening any sterile package, verify the kit model number, that
the kit is within its expiration (use-before) date, and that the packaging has not been damaged or
compromised in any way. If the packaging has been compromised, the device is beyond its expiration
date, or the sterile package or device show signs of damage, do not use the device as it may be
compromised and could cause harm to the patient. Return any suspect components to St. Jude
Medical for evaluation.
Handle the device with care. The clinician programmer and patient controller are sensitive electronic
devices that can be damaged by rough handling, such as dropping them on the ground.
Lead inspection. Carefully inspect the lead (in the sterile field) for damage after removing it from the
sterile package. Damage to the lead body can cause improper function and stimulation or stimulation to
areas other than the intended target.
Care and handling of components. Use extreme care when handling system components prior to
implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of
sharp instruments may damage and cause failure of the components.

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Component handling. Do not bend, kink, or stretch the lead body, sheaths, or other components as this
may result in damage to the component and poor function.
Using surgical instruments. Do not use surgical instruments to handle the lead. The force of the
instruments may damage the lead or stylet.
Component manipulation. Do not over-manipulate the sheath and lead system as this may result in
trauma within the epidural space.
Stylet handling. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it.
Use care when reinserting a stylet. Too much pressure on the stylet could damage the lead, resulting in
intermittent or loss of stimulation. Remove the stylet from the lead only when satisfied with lead
placement. If the stylet is removed from the lead, it may be difficult to reinsert it.
Sheath insertion precaution. Do not insert the sheath into the epidural space without the lead or
guidewire inserted, as this may cause injury to the dura. The standard implant lead cannot be loaded
into the sheath after the sheath is in the body. The SlimTip™ lead, however, can be loaded after the
sheath has been initially placed in the body.
Stabilizing the lead during insertion. When inserting the lead-sheath assembly through the needle into
the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Failure to do
so may cause harm to the patient such as damage to the dura.
Bending the sheath. Do not bend the sheath without the lead inside the sheath, as this will
permanently kink it and make it difficult to deploy the lead.

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Lead handling. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the
lead. Failure to do so may result in difficulty delivering the lead.
Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those
on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such
exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and
dry them completely prior to lead connection and implantation.
System testing. To ensure correct operation, always test the system during the implant procedure,
before closing the neurostimulator pocket, and before the patient leaves the surgery suite.
Component disposal. Return all explanted components to St. Jude Medical for safe disposal.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic
lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be
used, do not focus the energy near the IPG.
Home and Occupational Environments
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. Patients should avoid getting too close to these types of EMI sources, which
include the following examples: commercial electrical equipment (such as arc welders and induction

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furnaces), communication equipment (such as microwave transmitters and high-power amateur
transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, some medical
procedures (such as therapeutic radiation and electromagnetic lithotripsy), and some medical devices
(such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental
drills, and ultrasonic probes).
Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth®wireless
technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near
explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this
device, please ask for authorization to use it before turning it on. (Bluetooth®is a registered trademark
of Bluetooth SIG, Inc.)
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 places, and airport
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. Patients who are implanted
with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may
experience a momentary increase in their perceived stimulation, which some patients have described
as uncomfortable or jolting. Patients should cautiously approach such devices and should request help
to bypass them. If they must go through a gate or doorway containing this type of device, patients
should turn off their IPG and proceed with caution, being sure to move through the device quickly.

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Mobile phones. While interference with mobile phones is not anticipated, technology continues to
change and interaction between a neurostimulation system and a mobile phone is possible. Advise
patients to contact their physician if they are concerned about their mobile phone interacting with their
neurostimulation system.
Adverse Effects
In addition to those risks commonly associated with surgery, the following risks are associated with
using thisneurostimulation system:
Unpleasant sensations or motor disturbances, including involuntary movement, caused by
stimulation at high outputs (if either occurs, turn off your IPG immediately.)
Undesirable changes in stimulation, which may be related to cellular changes in tissue around the
electrodes, changes in electrode position, loose electrical connections, or lead failure or breakage
Stimulation in unwanted places (such as stimulation of the chest wall)
Lead migration, causing changes in stimulation or reduced pain relief
Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement
of a lead in the epidural space
Cerebrospinal fluid (CSF) leakage
Tissue damage or nerve damage
Paralysis, weakness, clumsiness, nu mbness, sensory loss, or pain below the level of the implant