Not intended as a substitute for the provided Patient System Handbook or the Patient Trial Handbook. The contents of the handbooks must be fully understood before using your Precision 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:
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.
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.
The Spectra WaveWriter 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 Guidelines for Spectra WaveWriter™ Spinal Cord Stimulator System.
Boston Scientific 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 room.
The safety and effectiveness of spinal cord stimulation has not been established for pediatric use.
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.
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.
Burns may result if the pulse generator case is ruptured or pierced and patient tissue is exposed to battery chemicals.
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 (subperception), postural changes are less likely to affect you.
Strong electromagnetic fields can potentially turn the Stimulator off, or cause uncomfortable or jolting stimulation. Avoid or exercise care around:
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 Charger 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.
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:
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.
Subperception Therapy. Subperception stimulation has been demonstrated to be safe and effective in patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least six months.
If you are using therapy that generates paresthesia you should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation turned on. Stimulation must be turned off first in such cases. Any sudden stimulation changes may distract you from proper operation of the vehicle, machinery, or equipment. For therapy that does not generate paresthesia (i.e., subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicle, machinery, and equipment.
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:
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.
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.
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.
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.
The operating temperature of the Trial Stimulator and Remote Control 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).
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.
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.
As an operator of the external devices, you should perform only the following service and maintenance tasks on the external devices:
Ensure that the devices are not in use while performing service and maintenance tasks.
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.
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:
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.