Spinal Cord Stimulator Systems
Indications of Use
PRESCRIPTIVE INFORMATION
The Boston Scientific System is indicated for use in spinal cord stimulation (SCS) as an aid in the management of chronic intractable pain.
The Boston Scientific System is indicated for use in the stimulation of the peripheral nerves (PNS) of the trunk as an aid in the management of chronic intractable pain.
Patients contraindicated for permanent SCS or PNS therapy are those who:
- are unable to operate the system
- have failed trial stimulation by failing to receive effective pain relief
- are poor surgical candidates
- 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 your healthcare provider.
Magnetic Resonance Imaging (MRI) for Spinal Cord Stimulation.
You may be able to have an MRI examination when specific conditions are met. These conditions are defined in the supplemental manual “ImageReady™ MRI Full Body Guidelines for Spinal Cord Stimulator Systems”. It is important that your Physician read this information in its entirety and determine all conditions are met before conducting and recommending an MRI examination. The “ImageReady™ MRI Full Body Guidelines Spinal Cord Stimulator Systems” manuals can be found on the Boston Scientific website (www.bostonscientific-elabeling.com and https://www.bostonscientific.com/imageready/en-EU/home.html).
Pediatric Use.
The safety and effectiveness of stimulation has not been established for pediatric use.
Diathermy.
As a 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 Pacemarkers.
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 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.
Posture.
Changes in posture or sudden movements may cause decreases, or 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. If using therapy that does not produce a sensation, postural changes are less likely to affect you.
Electromagnetic Interference.
Strong electromagnetic fields can potentially turn stimulation off, cause temporary unpredictable changes in stimulation, or interfere with the communication of the Remote Control. If an electromagnetic field is strong enough to turn stimulation off, this will be temporary and stimulation will automatically return once the electromagnetic field is removed. You should 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: If you must proceed through the detector, you should proceed with caution, ensuring that you move through the center of the detector as quickly as possible. Interference from these devices should not cause permanent damage to the implanted device.
- Security screeners: such as those used in Airport Security or at entrances to government buildings, including hand-held scanners: It is recommended that you request assistance to bypass the security screener and advise the security staff that you have an implanted medical device. If you must proceed through the security screener, move through the security screener quickly and stay as far as allowed from the screener. Interference from these devices should not cause permanent damage to the implanted device.
- 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 system that can broadcast a radio frequency (RF) signal. The high energy fields 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 Wi-Fi routers, Cordless Phones, Bluetooth® Wireless streaming devices, Baby Monitors, Microwave Ovens
When in close proximity, equipment that generates strong electromagnetic fields might cause unintended stimulation or interfere with wireless communication even if they comply with International Special Committee on Radio Interference (CISPR) requirements.
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 provider 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. If using therapy that does not produce a sensation, postural changes are less likely to affect you.
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 2.5 kilograms (5 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 any lifestyle changes due to decreases in pain.
Stimulator Orientation.
Never attempt to change the orientation of the Stimulator or turn over the Stimulator. Avoid touching the incisions or Stimulator site. If the Stimulator flips over in your body, it may be unable to communicate with the Remote Control or Clinician Programmer. If the rechargeable Stimulator flips over in your body, then it cannot be charged. If stimulation cannot be turned on after charging, contact your healthcare provider to arrange an evaluation of the system.
If you notice a change in appearance of the skin at the Stimulator location, such as the skin becoming thin over time, contact your healthcare provider.
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 repositioning 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 5 to 40 °C (41 to 104 °F). For proper operation, do not use the Charger (for rechargeable Stimulators) if the ambient temperature is above 35 °C (95 °F).
Storage, Handling and Transport.
Do not expose the Remote Control or Charging System (for rechargeable Stimulators) 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 to 60 °C (-4 to 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 provider for information.
Remote Control, Charging System, and External Trial Stimulator Cleaning.
The charging system components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. The Remote Control and External Trial Stimulator 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.
As an operator of the external devices, you should perform only the following service and maintenance tasks on the external devices:
- Changing the battery
- Charging the battery
- Cleaning
Ensure that the devices are not in use while performing service and maintenance tasks.
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 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 interference may cause the device to malfunction and affect stimulation.
- 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.
PATIENT IDENTIFICATION CARD
Ensure you have received your Patient Identification Card. If not, please call your healthcare provider.
END OF PROGRAMMED SERVICE
The software used by your System is programmed to end service after 12 years. As the Stimulator nears the end of the programmed period, the Remote Control provides the following indicator to inform you that the end of the programmed period is approaching:
- Remote Control - Approximately six months before the end of programmed period, the Remote Control displays a weekly message indicating the number of service days remaining. Approximately one month before the end of the programmed period, the message displays daily.
You should contact your healthcare provider upon receipt of the first message regarding the number of service days remaining.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France.