SCS system support

Indications for Use: 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, Diabetic Peripheral Neuropathy of the lower extremities. 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, multiple back surgeries.

Contraindications. The Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant. 

Warnings. Patients implanted with Boston Scientific Spinal Cord Stimulator Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to MRI may result in dislodgement of the stimulator or leads, heating of the stimulator, severe damage to the stimulator electronics and an uncomfortable or jolting sensation. As a Spinal Cord Stimulation patient, you should not have diathermy as either a treatment for a medical condition or as part of a surgical procedure. Strong electromagnetic fields, such as power generators or theft detection systems, can potentially turn the stimulator off, or cause uncomfortable jolting stimulation. The system should not be charged while sleeping. The Spinal Cord Stimulator system may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Advise your physician that you have a Spinal Cord Stimulator before going through with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Stimulation must be turned off first in such cases. 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 vehicles, machinery, and equipment. Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems. For complete indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747 or visit Pain.com.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.