Precision Montage™ MRI Spinal Cord Stimulator (SCS) System

Not intended as a substitute for the provided Patient System Handbook, the Patient Trial Handbook, or the Spinal Cord Stimulator System Information for Patients. The contents of the handbooks must be fully understood before using your Precision Montage MRI System.

The Boston Scientific Spinal Cord Stimulator Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. 

Associated conditions and etiologies may be: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, and multiple back surgeries.

Patients contraindicated for permanent SCS therapy are those who:

• are unable to operate the SCS system
• have failed trial stimulation by failing to receive effective pain relief
• are poor surgical risks
• are pregnant

UNAUTHORIZED MODIFICATION

Unauthorized modification to the medical devices is prohibited. System integrity could be compromised and harm or injury to the patient could occur if the medical devices are subjected to unauthorized modification.

Heat Due to Charging

Do not charge while sleeping. This may result in a burn. While charging, the Charger may become warm. It should be handled with care. Failure to use the Charger Belt or an adhesive patch, as shown in your Charger Handbook, may result in a burn. If you experience pain or discomfort, cease charging and contact Boston Scientific.

Magnetic Resonance Imaging (MRI)

The Precision Montage MRI SCS System with ImageReady MRI Technology is “MRI-Conditional” only when exposed to the MRI environment under the specific conditions defined in the ImageReady™  MRI Full Body Guidelines for Precision Montage™ MRI Spinal Cord Stimulator System.

Pediatric Use

The safety and effectiveness of spinal cord stimulation has not been established for pediatric use.

Diathermy

As an SCS patient, you should not have any form of diathermy either as treatment for a medical condition or as part of a surgical procedure. The high energy and heat generated by diathermy can be transferred through your stimulator system, causing tissue damage at the lead site and, possibly, severe injury or death. The Stimulator, whether it is turned on or off, may be damaged.

Cardiac Pacemakers

Spinal cord stimulators may interfere with the operation of implanted sensing stimulators, such as pacemakers and implantable cardiac defibrillators (ICDs). Be sure your physicians are aware of your spinal cord stimulator before going forward with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken.

Implant Damage

Burns may result if the pulse generator case is ruptured or pierced and patient tissue is exposed to battery chemicals.

Postural Changes

Changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived stimulation level. Keep the Remote Control with you at all times, and turn the stimulation down or off before making posture changes. If unpleasant sensations occur, the stimulation should be turned off immediately.

Electromagnetic Interference

Strong electromagnetic fields can potentially turn the Stimulator off, or cause uncomfortable or jolting stimulation, or affect wireless communication.  Avoid or exercise care around:

• Theft detectors or security screeners, such as those used at entrances/exits of department stores, libraries, and other public establishments, and/or airport security screening devices. It is recommended that you request assistance to bypass the device. If you must proceed through the device, turn off the Stimulator and proceed with caution, and move through the center of the screener as quickly as possible.
• Power lines or power generators
• Electric steel furnaces and arc welders
• Large, magnetized stereo speakers
• Tag deactivators such as those found in retail stores and libraries

Note: When in close proximity, equipment that generates strong electromagnetic fields might cause uncomfortable or jolting stimulation or interfere with wireless communication even if they comply with CISPR requirements.

If you are near these devices, you may become aware of changing stimulation levels. In rare instances, if the stimulation is on, you could experience an increase in stimulation level to the point that the sensation is uncomfortably strong or possibly “jolting.” If this happens, turn off the Stimulator. If the Stimulator suddenly turns off by itself, first move away from the area. Next, check the stimulation status with the Remote Control by pressing the Unlock button and observing the screen. The implant may need to be recharged before stimulation can be restarted. Refer to your Charging Handbook for further information.

Always be aware of your surroundings, particularly near theft detectors/security screeners. Ask for assistance to go around these devices if you feel at all uncomfortable. 

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 — high-output sound or shock waves often used to treat gall stones and kidney stones
• electrocautery — the use of a heated electric probe to stop bleeding during surgery
• external defibrillation — the use of electrically charged paddles to restart the heart in an emergency
• radiation therapy — ionizing energy commonly used to treat cancer. Any damage to the device by radiation may not be immediately detectable.
• ultrasonic scanning — very high frequency sound waves used to produce images of internal organs or tissue for diagnostic purposes
• high-output ultrasound — high frequency sound waves which may be applied as physical therapy to treat certain bone/muscle injuries, or for muscle stimulation, or to improve blood flow

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.

Before having procedures, medical therapies, or diagnostics, have your healthcare professional call our Customer Service department for proper instructions. Refer to “Contacting Boston Scientific” in this manual for contact information for your locality.

Automobiles and Other Equipment

Do not operate an automobile, other motorized vehicle, or any potentially dangerous machinery/equipment with therapeutic stimulation switched on. Turn off stimulation first. Sudden stimulation changes, if they occur, may distract you from attentive operation of the vehicle or equipment.

Post Operative

During the two weeks following surgery, it is important to use extreme care so that appropriate healing will secure the implanted components and close the surgical incisions:

• Do not lift objects of more than five pounds.
• Do not engage in rigorous physical activity such as twisting, bending, or climbing.
• If new leads were implanted, do not raise your arms above your head.
• While undergoing patient trial, do not pull or jiggle the leads.

Temporarily, there may be some pain in the area of the implant as the incisions heal. If discomfort continues beyond two weeks, contact your physician.

If you notice excessive redness around the wound areas during this time, contact your physician to check for infection and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this period.

Be sure to consult your physician before making lifestyle changes due to decreases in pain.

Stimulator Location

Never attempt to change the orientation or "flip" (rotate or spin) the implant. Do not "finger" or play with the implant. If the implant flips over in your body it cannot be charged. If you know that the device has turned, or if stimulation cannot be turned on after charging, contact your physician to arrange an evaluation of the system.

In some cases, the skin over your implant may become very thin over time. If this occurs, contact your physician.

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, consult your physician who may be able to restore stimulation by reprogramming the implant in the clinic or re-positioning the lead during another operation.

Device Failure

Implants 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), turn off the Stimulator and contact your physician so that the system can be evaluated.

Operating Temperature

The operating temperature of the Trial Stimulator and Remote Control is 10–40 °C (50–104 °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, be careful that the storage temperature does not exceed -20–60 °C (-4–140 °F).

Handle the system components and accessories with care. Do not drop them or submerge them in water. Avoid all sources of water which can come into contact with the devices. 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 the components. Refer to the Limited Warranty for additional information.

Component Disposal

Do not dispose of the Remote Control or Charger in fire. The battery in these devices can explode in fire. Dispose of used batteries in accordance with local regulations. The Stimulator should be explanted in the case of cremation, and returned to Boston Scientific. External devices to be disposed of per local regulatory requirements. Please contact your healthcare professional for information.

Remote Control, Charging System Cleaning

The charging system components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. The Remote Control 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.

Cell Phones

While we do not anticipate any interference caused by 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 physician should be contacted.

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:

• The lead(s) which deliver stimulation may move from their original implanted location, 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 battery leakage, device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control.
• Your body may react negatively to the materials used to manufacture the Stimulator or the leads. You may notice redness, warmth or swelling of the implant area.
• 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 deficit, including paralysis.  Time to onset is variable, possibly ranging from weeks to years after implant.
• The skin over your implant may become thin and increasingly tender over time. A seroma may be formed.
• The most common surgical procedural risks are temporary pain at the implant site and infection. However, since the leads are placed in the epidural space, there is a small risk that spinal fluid may leak from the lead insertion site following surgery. Very rarely, you may develop an internal blood clot (hematoma) or blister (seroma); or you may experience epidural hemorrhage or paralysis. Your spinal cord may become compressed.
• External sources of electromagnetic disturbance  may cause the device to malfunction and affect stimulation.
• MRI. Exposure to magnetic resonance imaging (MRI) can result in discomfort or injury due to heat near the Stimulator or the leads, tugging or vibration of the implanted system induced stimulation, damage to the device requiring its replacement and may distort the image needed for diagnosis
• 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.
• You may experience painful electrical stimulation of your chest wall as a result of stimulation of certain nerve roots several weeks after surgery.
• Over time, your implant may move from its original position.
• You may experience weakness, clumsiness, numbness or pain below the level of implantation.
• You may experience persistent pain at the Stimulator or lead site.

In any event, you should contact your physician and inform him/her.

CAUTION: Federal law restricts this device to the sale, distribution and use by or on the order of a physician.