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Boston Scientific Stereotactic TCD Electrodes

Indications for Use

The Boston Scientific Disposable Stereotactic TC Electrode is indicated for use in RF heat lesioning of nervous tissue, including the Central Nervous System.

Warnings

For a patients with cardiac pacemakers, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.

If any physiological monitoring of electrical apparatus is to be used on the patient in addition to the RF Generator, the safety aspects of the combination should be examined and approved by biomedical personnel.

If the patient has a spinal cord stimulator, contact the manufacturer of the stimulator to determine whether the stimulator needs to be in the bipolar stimulation mode and in the OFF position. If the spinal source is grounded, the RF current may go through the spinal cord stimulator and cause excessive damage and heating of the spinal cord.

Do not modify Boston Scientific equipment. Any modifications may compromise the safety and efficacy of the device.

Do not use with components not manufactured by Boston Scientific. Use of non-Boston Scientific products can result in procedure complications, and potentially serious injury.

Do not interchange components from different electrode kits. Using the wrong component can result in serious patient injury.

Discontinue use if erratic or sluggish temperature readings are observed, which may indicate a faulty cable connection, broken temperature sensor of the electrode, or loss of RF power into an undesired location.

DO NOT USE A NEEDLE AS A DISPERSIVE ELECTRODE. A needle may cause skin burns at the reference site due to high current densities. Care should be taken to maximize the surface area of the dispersive electrode. The dispersive electrode should be reliably attached with its entire surface area against the patient’s body.

CAUTION: When using the generator near or in anatomy of the Central Nervous System (e.g. Trigeminal ganglion, spinal cord, brain stem, brain), it is recommended that only one electrode be energized at a time (i.e. Electrode Setup: RF Type=Standard & Active Electrodes=1, see Section 5.1 in the G4 Operator’s Manual) and that the Output Control Knob be used for manual control of the output level (i.e. Auto Ramp=Off, see Sections 6.1, 7.1, 8.1 in the G4 Operator’s Manual). The physician should pay close attention to generator readings and patient response at all times.

Precautions

Recording RF voltage, current, power, and tip temperature is recommended for each procedure since it gives the physician a measure of parameter normalcy for a given procedure and electrode size. Any anomalously high voltage and currents would be apparent and signal possible problems.

Prior to each procedure, check cable, electrode tip, and electrode insulation for damage.

Adverse Events

The following adverse events or complications are possible with this procedure: hemianesthesia, limb dystonia, worsening dysarthria, dysphasia, cerebral infarction, intracerebral hematoma, oculomotor palsy, hemiballismus, persistent hemiparesis, persistent gait disturbance, persistent numbness, seizure, transient monoparesis or facial palsy, homonymous hemianopsia, worsening of balance, worsening of depression, acute confusion, personality change, cognitive disorder, worsening of dementia, weight gain, and/or death.

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, 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. The Boston Scientific Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems are also indicated as an aid in the management of chronic intractable unilateral or bilateral low back and leg pain without prior back surgery.

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.

MR Conditional symbol

Boston Scientific’s ImageReady™ MRI Technology makes safe MRI head scans possible. Patients implanted with the Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems with ImageReady™ MRI Technology are "MR Conditional" only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Head Only Guidelines for Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems.

MR Conditional symbolBoston Scientific’s ImageReady™ MRI Full Body Technology makes safe MRI scans possible. The Precision Montage™ MRI, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems with ImageReady™ MRI Full Body Technology are “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Full Body Guidelines for Precision Montage™ MRI or WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems.

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.

Indications for Use: The Superion™ Indirect Decompression System (IDS) is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, having radiographic evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion™ Interspinous Spacer is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain, who have undergone at least 6 months of non-operative treatment. The Superion Interspinous Spacer may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5. Contraindications, warnings, precautions, side effects. The Superion Indirect Decompression System (IDS) is contraindicated for patients who: have spinal anatomy that prevent implantation of the device or cause the device to be unstable in situ (i.e., degenerative spondylolisthesis greater than grade 1), Cauda equina syndrome, or prior decompression or fusion at the index level, scoliosis or spinous process fractures, osteoporosis, infection, allergy or reaction to any metal or implant or a high Body Mass Index. Avoid strenuous activity for 6 weeks after surgery, contact your physician if there is fluid leaking from your incision, if you have pain, swelling or numbness in your legs or buttocks or if you fall. Refer to the Instructions for Use provided on www.vertiflex.com for additional Indications for Use, contraindications information and potential adverse effects, warnings, and precautions prior to using this product. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Indications for Use: The Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula are indicated for use in procedures to create radiofrequency lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution for radiofrequency lesioning of peripheral nerve tissue only. The Boston Scientific LCED and Stereotactic TCD Electrodes are indicated for use in radiofrequency (RF) heat lesioning of nervous tissue including the Central Nervous System.

Warnings: The Boston Scientific RF devices may cause interference with active devices such as neurostimulators, cardiac pacemakers, and defibrillators. Interference may affect the action of these active devices or may damage them. For appropriate guidance, consult the instructions for use for these active devices. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

§The physician locator tool identifies pain management specialists in your area who have met certain qualifying criteria and are experienced with one or more of Boston Scientific pain management therapies. All treatment options should be discussed thoroughly with a pain management specialist.