Boston Scientific Precision Montage Owner's manual

Precision Montage™
MRI Spinal Cord
Stimulator System
Information for Prescribers
91053246-02
Content: 91114311 REV AC
Information for Prescribers
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Information for Prescribers
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Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information
relating to its products in order to improve their reliability or operating capacity.
Trademarks
All trademarks are the property of their respective holders.
Additional Information
For Indications and related information, see the Indications DFU. For other device-specic
information not included in this manual, labeling symbols, and warranty information, refer to the
appropriate DFU for your SCS System as listed on your Reference Guide.

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Table of Contents
Device and Product Description ..............................................................................................1
Contraindications......................................................................................................................1
Safety Information.....................................................................................................................1
Instructions for the Patient ..................................................................................................1
Instructions for the Physician ..............................................................................................8
Essential Performance .......................................................................................................8
Telemetry Information ........................................................................................................8
Sterilization .........................................................................................................................9
Electromagnetic Compatibility ..........................................................................................10
Technical Service ..............................................................................................................14
End of Programmed Service .............................................................................................14
IPG Battery Life ................................................................................................................ 15

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Magnetic Resonance Imaging (MRI).
• The Precision Montage MRI Spinal Cord Stimulator (SCS) System is “MR Conditional”.
An MRI examination can be conducted safely using only a 1.5 Tesla horizontal closed-
bore whole-body MRI system for the MRI scan when all instructions in the supplemental
manual “ImageReady™ MRI Full Body Guidelines for Precision Montage MRI Spinal Cord
Stimulator System” are followed. The 1.5T MRI system can be congured to use the Full
Body, Head, and Extremity transmit/receive RF quadrature coils, and receive only coils of
any type. It is important to read the information in this supplemental manual in its entirety
before conducting or recommending an MRI examination on a patient with a Precision
Montage MRI SCS System. The “ImageReady™ MRI Full Body Guidelines for Precision
Montage MRI Spinal Cord Stimulator System” manual appears on the Boston Scientic
websites (www.bostonscientic.com/MRI and www.bostonscientic.com/ImageReady). MRI
examinations performed on patients with the Precision Montage MRI System using open-
sided MRI systems, or other types of MRI systems operating at other static magnetic eld
strengths (higher or lower) have not been assessed and, as such, should not be performed.
• External Devices: Boston Scientic external components (i.e., External Trial Stimulator
and OR Cable, Remote Control and accessories, Battery Charger) are MR Unsafe.
They must not be taken into any MR environment such as the MRI scanner.
Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been established
for pediatric use.
Diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be
used on SCS patients. The energy generated by diathermy can be transferred through the
Stimulator system, causing tissue damage at the lead site and resulting in severe injury or
death. The IPG, whether it is turned on or off, may be damaged.
Implanted Stimulation Devices. Spinal cord stimulators may interfere with the operation of
implanted sensing stimulators such as pacemakers or cardioverter debrillators. The effects of
implanted stimulation devices on neurostimulators is unknown.
Stimulator Damage. Burns may result if the pulse generator case is ruptured or pierced
and patient tissue is exposed to battery chemicals. Do not implant the device if the case is
damaged.
Postural Changes. Patients should be advised that changes in posture or abrupt movements
may cause decreases, or uncomfortable or painful increases in the perceived stimulation
level. Patients should be advised to turn down the amplitude or turn off the IPG before making
posture changes.
Important: If unpleasant sensations occur, the IPG should be turned off immediately.

Safety Information
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Electromagnetic Interference. Strong electromagnetic elds can potentially turn the
Stimulator off, cause temporary unpredictable changes in stimulation, or interfere with the
Remote Control communication. Patients should be counseled to avoid or exercise care around
the following:
• Theft detectors, tag deactivators and RFID devices, such as those used at department
stores, libraries, and other public establishments. The patient should proceed with
caution, ensuring to move through the center of the detector as quickly as possible.
• Security screeners, such as those used in Airport Security or at entrances to government
buildings, including hand-held scanners. The patient should request assistance to
bypass the device. If the patient must pass through the security screener, they should
move quickly through the device staying as far from the physical device as allowable.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other
anti-theft systems that can broadcast a radio frequency (RF) signal. The
high energy elds produced by these systems may interfere with the
operation of the Remote Control and its ability to control stimulation.
• Other sources of electromagnetic disturbance, such as RF transmitters
at television or radio broadcast stations, Amateur Radio or Citizens Band
radio transceivers, or Family Radio Service band transceivers.
Note: When in close proximity, equipment that generates strong electromagnetic
elds might cause unintended stimulation or interfere with wireless
communication even if they comply with International Special
Committee on Radio Interference (CISPR) requirements

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Precautions
Physician training is required.
Medical Devices/Therapies. The following medical therapies or procedures may turn
stimulation off or may cause permanent damage to the Stimulator, particularly if used in close
proximity to the device:
• lithotripsy
• electrocautery (See “Instructions for the Physician” on page 8)
• external debrillation
• radiation therapy (Any damage to the device by radiation may not be immediately
detectable.)
• ultrasonic scanning
• high-output ultrasound
X-ray and CT scans may damage the Stimulator if stimulation is on. X-Ray and CT Scans are
unlikely to damage the Stimulator if stimulation is turned off.
If any of the above is required by medical necessity, refer to “Instructions for the Physician” on
page 8. Ultimately, however, the device may require explantation as a result of damage to
the device.
Automobiles and Other Equipment. Patients should not operate automobiles, other
motorized vehicles, or potentially dangerous machinery/ equipment with therapeutic stimulation
switched on. Stimulation must be turned off rst. Sudden stimulation changes, if they occur,
may distract patients from attentive operation of the vehicle or equipment.
Post Operative. During the two weeks following surgery, it is important that patients use
extreme care so that appropriate healing will secure the implanted components and close the
surgical incisions:
• Patients should not lift objects of more than 2.5 kilograms (ve pounds).
• Patients should not engage in rigorous physical activity such as twisting, bending, or
climbing.
• If new leads were implanted, patients should not raise their arms above their head.
Temporarily, there may be some pain in the area of the implant as the incisions heal. Patients
should be instructed that if discomfort continues beyond two weeks, they should contact their
physician.
If patients notice excessive redness around the wound areas during this time, they should
contact their physician to check for infection and administer proper treatment. In rare cases,
adverse tissue reaction to implanted materials can occur during this period.
Patients should consult their physician before making lifestyle changes due to decreases in
pain.

Safety Information
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Stimulator Location. Patients should never attempt to change the orientation or “ip” (rotate
or spin) the Stimulator. Patients should not “nger” or play with the Stimulator. If the Stimulator
ips over in the Patient’s body, it cannot be charged. If the Patient knows that the device has
turned, or if stimulation cannot be turned on after charging, the Patient should contact his or her
physician to arrange an evaluation of the system. In some cases, the skin over the Stimulator
may become very thin over time. If this occurs, Patients should contact their physicians.
Lead Location. In some instances a lead can move from its original location, and stimulation
at the intended pain site can be lost. If this occurs, Patients should consult their physician who
may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning
the lead during another operation.
Device Failure. Stimulators can fail at any time due to random component failure, loss of
battery functionality, or lead breakage. If the device stops working even after complete charging
(up to four hours), Patients should turn off the Stimulator and contact their physician so that the
system can be evaluated.
Operating Temperature. The operating temperature of the Trial Stimulator, Remote Control,
and Programming Wand is 5–40 °C (41–104 °F). For proper operation, do not use the Charger
if the ambient temperature is above 35 °C (95 °F).
Storage, Handling and Transport. Do not expose the Remote Control or Charging System
components to excessively hot or cold conditions. Do not leave the devices in your car
or outdoors for extended periods of time. The sensitive electronics can be damaged by
temperature extremes, particularly high heat.
If the Remote Control or the Charging System is to be stored for a period of time without
batteries, the storage temperature should not exceed -20 to 60 °C (-4 to 140 °F).
Handle the system external components and accessories with care. Do not drop them or
submerge them in water. Although reliability testing has been performed to ensure quality
manufacturing and performance, dropping the devices on hard surfaces or in water, or other
rough handling, can permanently damage these components. (See “Limited Warranty - IPG”.)
Upon completion of the Patient Trial, remove the batteries from the Trial Stimulator.
Component Disposal. Do not dispose of the Remote Control or Charger in re. The battery
in these devices can explode in re. Dispose of used batteries in accordance with local
regulations. The IPG should be explanted in the case of cremation, and returned to Boston
Scientic. External devices to be disposed of per local regulatory requirements. Please contact
your healthcare professional.

Information for Prescribers
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Remote Control, Charging System, External Trial Stimulator and Wand Cleaning. The
charging system components can be cleaned using alcohol or a mild detergent applied with a
cloth or tissue. The Remote Control, External Trial Stimulator and Programming Wand can be
cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from
soapy detergents should be removed with a cloth lightly dampened with water. Do not use
abrasive cleansers for cleaning. Do not clean any of the accessories while they are directly or
indirectly connected to a power outlet.
Cell Phones. While we do not anticipate any interference with cell phones, the full effects
of interaction with cell phones are unknown at this time. If there is a concern or a problem is
encountered, the patients should contact their physician.
Adverse Effects
Potential risks are involved with any surgery.
The possible risks of implanting a pulse generator as part of a system to deliver spinal cord
stimulation include:
• Lead migration, resulting in undesirable changes in stimulation and subsequent reduction in
pain relief.
• System failure, which can occur at any time due to random failure(s) of the components
or the battery. These events, which may include device failure, lead breakage, hardware
malfunctions, loose connections, electrical shorts or open circuits and lead insulation
breaches, can result in ineffective pain control.
• Tissue reaction to implanted materials can occur. In some cases, the formation of reactive
tissue around the lead in the epidural space can result in delayed onset of spinal cord
compression and neurological/sensory decit, including paralysis. Time to onset is variable,
possibly ranging from weeks to years after implant.
• Skin erosion at the IPG site can occur over time.
• Possible surgical procedural risks are: temporary pain at the implant site, infection,
cerebrospinal uid (CSF) leakage and, although rare, epidural hemorrhage, seroma,
hematoma and paralysis.
• External sources of electromagnetic interference may cause the device to malfunction and
affect stimulation.
• Exposure to MRI can result in heating of tissue, image artifacts, induced voltages in the
neurostimulator and/or leads, lead dislodgement.
• Undesirable stimulation may occur over time due to cellular changes in tissue around the
electrodes, changes in electrode position, loose electrical connections and/or lead failure.