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 Plus 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:
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 with either the Charging Belt or an adhesive patch, as shown, may result in a burn. If you experience pain or discomfort, cease charging and contact Boston Scientific.
Patients implanted with the Precision System should not be subjected to MRI. MRI exposure may result in dislodgement of implanted components, heating of the neurostimulator, damage to the device electronics and/or voltage induction through the leads and Stimulator causing an uncomfortable or "jolting" sensation.
The safety and effectiveness of spinal cord stimulation has not been established for pediatric use.
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 which may result in severe injury or death. The IPG, 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 or cardioverter defibrillators. The effects of implanted stimulation devices on neurostimulators is unknown.
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.
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. If unpleasant sensations occur, the IPG should be turned off immediately.
Strong electromagnetic fields can potentially turn the Stimulator off, or cause uncomfortable or jolting stimulation. Patients should be counseled to avoid or exercise care around:
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:
If any of the above is required by medical necessity, refer to "Instructions for the Physician" page 15. Ultimately, however, the device may need to be explanted as a result of associated failure.
Patients should not operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with therapeutic stimulation switched on. Stimulation must be turned off first. Sudden stimulation changes, if they occur, may distract patients from attentive operation of the vehicle or 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" the Stimulator. Do not "finger" or play with the Stimulator. If the Stimulator 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 Stimulator 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 able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning the lead during another operation.
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), turn off the Stimulator and contact your physician so that the system can be evaluated.
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. For proper operation, do not use the Charger if the ambient temperature is above 95 °F (35 °C).
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 -4 to 140 °F (-20 to 60 °C).
Handle the system 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 the components. (See "Limited Warranty" page 63.)
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 IPG 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.
The components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy detergents should be removed with a damp cloth. Do not use abrasive cleansers for cleaning.
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. In addition to those typically associated with surgery, the possible risks of stimulation system implantation include:
In any event, instruct the patient to contact their physician to inform him/her.
CAUTION: Federal law restricts this device to the sale, distribution and use by or on the order of a physician.