Indications, safety, and warnings for Radiofrequency System

G4 Generator

The Boston Scientific G4 Radiofrequency Generator is 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 G4 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes.

Intended Patient Population

Patients afflicted with neurological disorders are the intended patient population of the Boston Scientific G4 Radiofrequency Generator.

Intended User Profile

Neurosurgeons, Anesthesiologists, and Pain Clinicians are the intended user profile of the Boston Scientific G4 Radiofrequency Generator.

Use Environment

The Boston Scientific G4 Radiofrequency Generator is used in a surgical setting as an RF power source to deliver energy through RF Electrodes, and is designed to be as light and portable as possible in this environment. Guidance for electromagnetic environment states is as follows: Floors should be wood, concrete or ceramic tile; if floors are covered with synthetic material, the relative humidity should be at least 30%; mains power quality and power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment.

Operating Principle

The Boston Scientific G4 Radiofrequency Generator is a high frequency surgical equipment used to generate RF and stimulation signals within specified limits; measure the radiofrequency voltage, current, and power output to specified accuracy within specified range; measure the impedance of the RF system to specified accuracy within specified range; and measure temperature at the RF Electrode to specified accuracy within specified range.

 

LCED Electrode

The LCE Electrode is indicated for use in radiofrequency (RF) heat lesioning of nervous tissue including the Central Nervous System. Examples of RF procedures to treat chronic intractable pain include: cordotomy, ganglionotomy, rhizotomy, and neurotomy.

 

Stereotactic TCD

The Boston Scientific Disposable stereotacticTCD Electrode is indicated for use in RF heat lesioning of nervous tissue, including the Central Nervous System. Examples of RF procedures include thalamotomy and pallidotomy to treat movement disorders such as Parkinson’s disease, dystonia, or essential tremor which are not adequately controlled by medication.

 

TCN Electrode

The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.

 

CSK Electrode

The CSK Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.

 

CC-RFK RF Cannula SOURCE

The Boston Scientific CC RF Cannula and RFK RF Cannula are indicated for use in RF heat lesion procedures for the relief of pain from peripheral nerve tissue only.

 

RF Single-Use Electrodes and Needles

The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning of peripheral nerve tissue only. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made. The CN is used for percutaneous nerve blocks only.

 

Flextrode Electrode and Cannula

The Boston Scientific Flextrode is used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning of peripheral nerve tissue only. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made.

 

RCE Electrode and Cannula

The Boston Scientific RCE system is used for percutaneous nerve blocks with local anesthetic solution or for RF lesioning of peripheral nerve tissue only. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a RF lesion is made.

 

SideKick 2 Cannula

The Boston Scientific SideKick 2 Cannula is indicated for use in RF heat lesion procedures for the relief of pain from peripheral nerve tissue only.

LCED Electrode

The procedure is contraindicated in patients with conditions that could significantly increase surgical risk such as coagulopathy, active infection at the surgical site, pregnancy, anesthetic allergy, or serious cognitive or psychological impairment. Cordotomy is contraindicated in patients with severe pulmonary dysfunction. Cordotomy is contraindicated for patients with bilateral intractable pain of the chest and arms, because bilateral high cervical cordotomy has a high risk of respiratory complications or death. Bilateral high (C1-C2) cervical cordotomy is contraindicated for all patients.

 

Stereotactic TCD

The procedure is contraindicated in patients with conditions that could significantly increase surgical risk such as coagulopathy, active infection at the surgical site, pregnancy, anesthetic allergy, or serious cognitive or psychological impairment.

G4 Generator

Electric Shock Hazard There are no user serviceable parts inside the G4. To avoid electric shock, return the device to Boston Scientific for servicing.

Hazardous Electrical Equipment & Active Implants This equipment is intended for use by qualified personnel only. This equipment may damage or interfere with the operation of cardiac pacemakers and other active implants. Do not use within 15 feet (4 meters) of a cardiac pacemaker unless proper cautions have been taken. Before use of the G4 RF Generator, 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. This equipment has an output which is capable of causing a physiological effect.

Risk of Burns and Fire Do not use near conductive materials such as metal bed parts or inner spring mattresses.

Protective Earth Grounding Grounding reliability can only be achieved when the equipment is plugged into a receptacle marked “Hospital Grade”. Any interruption of the Protective Earth conductor will result in a potential shock hazard which cause injury to patient or operator.

A needle electrode should not be used as the dispersive electrode, as it is possible to burn the patient at this site due to high current densities. In all applications, care should be taken to maximize the surface area of the dispersive electrode. The dispersive electrode should be reliably attached with its entire area against the patient’s body and as close to the operating field as possible.

NOTICE: The physician and support staff must be the ultimate judge of the appropriateness of, and the method used to perform any medical procedure performed using Boston Scientific equipment. It is not the province of Boston Scientific to instruct in the proper medical use of the equipment. The availability of output modes, settings values, and default settings values on the G4 RF Generator should not be construed as a recommendation of the medical appropriateness of their use in a specific case.

Proper electrode placement should be verified using anatomical landmarks, sensory and motor stimulation techniques, fluoroscopic guidance, Impedance reading, and good clinical judgment before RF lesion making procedures are initiated.

The long-term risks of creation of RF lesions have not been established.

Do not perform maintenance on the generator while it is in use.

The Boston Scientific RF device (G4 Generator) 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. Please consult the instructions for use for these active devices for appropriate guidance. WARNING: Electromagnetic interference (EMI) produced by the unit during normal operation may adversely affect the performance of other equipment. The performance of this device may be adversely affected by other high frequency surgical devices in close proximity. If a problem occurs, separate the devices. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the generator, including cables. Otherwise, degradation of performance of this equipment could result.

Electrodes and probes of monitoring, stimulating and imaging devices, and metallic and conductive implanted hardware or probes, can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this G4 RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.

Potentially hazardous conditions may exist when accessories of similar connector types are combined. Use only appropriate accessories certified by an accredited test body.

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Do not touch the USB port and the patient simultaneously.

NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A).

The use and proper placement of dispersive electrodes is a key element in the safe and effective use of this Radiofrequency lesion generator, particularly in the prevention of burns. Read and follow Boston Scientific’s dispersive electrode instructions for preparation, placement, surveillance, removal and use of any dispersive electrode. It is recommended that dispersive electrodes be used that meet or exceed the requirements of EN60601-2-2. Use a Boston Scientific approved gel-pad dispersive electrode with at least 110 cm² conductive plate area to disperse and return RF current over as large an area as possible, and thus minimize heating effects at that electrode, and to avoid high current densities and resultant burns in adjacent tissue.

NOTICE: The ground pad should be placed in close proximity to the lesion site.

Observe the dispersive electrode during lesioning for signs of excessive heating.

NOTICE: Use of an approved ground pad with a stainless steel RF Cannula may provide a galvanic potential (the “battery effect”) resulting in a single stimulation pulse at the time the TC Electrode is placed into an RF Cannula. This should be anticipated, and does not present any risk or danger to the patient.

Skin burns can result from the improper use of Ground Pads, including, but not limited to, the following:

• Use of Ground Pads with a conductive plate area less than 110 cm2.
• Use of expired Ground Pads or Ground Pads with dried gel.
• Ground Pads not placed on a well vascularized, muscular, convex area of patient skin.
• Use on patient with peripheral vascular deficiency.
• Reuse or repositioning of Ground Pad.
• Ground Pad placement over scar tissue, inflamed skin, adipose tissue, bony prominences, metal prostheses, ECG electrodes and cables, pacemakers, and areas where fluid may pool.
• Use of Ground Pad not in accordance with this G4 RF Generator Operator’s Manual.
• Use of a needle as dispersive electrode since a needle may cause skin burns at the reference site due to high current densities.

Never proceed in a temperature monitored procedure if the generator does not read body temperature before you begin delivering RF energy.

Verify functional safety of the device before each use, using the guidelines detailed in this manual.

To avoid unanticipated stimulation to the patient, do not cycle the generator power or turn the generator power on while the patient is connected to the generator.

The output of any electrode may change when patient output is being delivered. Do not move electrode(s) or change electrode connections to the generator when patient output is being delivered to any electrode.

The generator is capable of delivering a significant amount of output. Patient or operator injury can result from improper handling of the active electrode and dispersive electrode, particularly when operating the generator. During energy delivery, the patient should not be allowed to come in contact with metal parts which are earthed or which have an appreciable capacitance to earth. The use of antistatic sheeting is recommended for this purpose. Unshielded leads (active or return) should be positioned so that they cannot come into contact with the patient or other leads connected to the patient and so that they do not run parallel to nearby leads.

To avoid accidental burns:

• Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.
• For surgical procedures where the high-frequency current could flow through parts of the body having a relatively small cross sectional area, the use of bipolar techniques may be desirable in order to avoid unwanted tissue damage.
• The output power selected should be as low as possible for the intended purpose.

Failure of the generator could result in an unintended increase of output power.

Apparent low power output or failure of the equipment to function correctly at normal settings may indicate faulty application of the dispersive electrode or failure of an electrical lead. Do not increase power before checking for obvious defects or misapplication. Effective contact between the patient and the dispersive electrode must be verified whenever the patient is repositioned after the initial application of the dispersive electrode. WARNING: Do not continue the application of RF if Temperature readings are erratic or do not rise a sufficiently rapid rate for the amount of RF energy applied. Erratic or sluggish Temperature readings may indicate a faulty cable connection, broken

Temperature sensor of the electrode, loss of RF Power into an undesired location, an inability of the generator to control the Temperature or RF output of the electrode, or a misalignment of the temperature-sensing electrode tip with the uninsulated tip of the RF Cannula into which it is inserted.

NOTICE: Always have spare electrodes and cables on hand in case a problem arises with the first one during a procedure. Reuseable cables and accessories should be periodically tested.

Any modification of the G4 Radiofrequency Generator done by unauthorized agents compromises the safety and efficacy of the equipment.

When connecting any non-medical peripheral equipment to this device, it must be ensured that the equipment combination meets the requirements of IEC 60601-1.

Do not mix types and sizes of electrodes when delivering output to more than one electrode. All electrodes and their associated needles used in a multi electrode configuration, including Bipolar configurations, should be identical.

Do not deliver Pulsed RF output to any electrode whose active tip exposure is less 2 mm or whose diameter is less than 23 Gauge. The temperature response of such an electrode is too rapid for Automatic Temperature Control in Pulsed RF mode.

Do not use the generator in a multi-electrode configuration with any electrode(s) whose active tip exposure is less than 2 mm or whose diameter is less than 23 Gauge. The temperature response of these electrodes is too rapid for Automatic Temperature Control of multiple such electrodes in Thermal RF and Pulsed RF modes. WARNING: Do not move electrode(s) or change electrode connections to the generator when patient output is being delivered to any electrode.

Do not place multiple electrodes too close together to create a large lesion when using a monopolar electrode configuration (i.e. Electrode Setup RF Type=Standard). Failure to comply can cause a lesion with unpredictable size and shape and may result in patient injury.

Do not place two bipolar electrode pairs too close together when using Electrode Setup RF Type=Bipolar and Active Electrodes=4. Failure to comply can cause a lesion with unpredictable size and shape and may result in patient injury.

Do not attach a ground pad to the generator or to the patient when using Electrode Setup RF Type=Bipolar. Both the ground pad and the reference electrodes (Electrodes 2 and/or 3) are at reference potential and will draw Current from the active electrodes (Electrodes 1 and/or 4). Failure to comply can cause a lesion with unpredictable size and shape and may result in patient injury.

Poor calibration of the touch screen may cause user input to be recognized incorrectly.

Electric Shock Hazard There are no user serviceable parts inside the G4. To avoid electric shock, return the device to Boston Scientific for servicing.

Risk of fire. Fuse must be replaced as marked.

 

LCED Electrode

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.

Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer. Do not use a needle as a dispersive electrode, since a needle may cause skin burns at the reference site due to high current densities.

 

Stereotactic TCD

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.

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.

 

TCN Electrode

Use only the ground pads provided by Boston Scientific. Failure to do so may result in patient injury or damage to the product.

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.

These devices are not intended to be used in an MRI environment and have not been evaluated for safety in an MRI environment.

Electrodes and probes of monitoring, stimulating, and patient contacting imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.

Do not modify this product, as modification could result in a safety hazard.

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

Do not use a needle as a dispersive electrode since a needle may cause skin burns at the reference site due to high current densities.

Prior to use, visually inspect the electrode for damage or contamination. If the electrode is damaged please contact Boston Scientific customer support team. If the electrode is contaminated, clean and sterilize per the instructions below. Magnification may be necessary for proper visual inspection.

Users must adhere to universal precautions when handling or using this device to prevent transmission of diseases.

 

CSK Electrode

Use only the ground pads provided by Boston Scientific. Failure to do so may result in patient injury or damage to the product.

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.

Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.

Do not modify this product, as modification could result in a safety hazard.

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

Do not use a needle as a dispersive electrode, since a needle may cause skin burns at the reference site due to high current densities.

Prior to use, visually inspect the electrode for damage or contamination. If the electrode is damaged please contact Boston Scientific customer support team. If the electrode is contaminated, clean and sterilize per the instructions below. Magnification may be necessary for proper visual inspection.

Users must adhere to universal precautions when handling or using this device to prevent transmission of diseases.

CC-RFK RF Cannula SOURCE

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.

Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.

Skin burns can result from the improper use of Ground Pads, including, but not limited to, the following:

• Use of Ground Pads with a conductive plate area less than 110 cm2.
• Use of expired Ground Pads or Ground Pads with dried gel.
• Ground Pads not placed on a well vascularized, muscular, convex area of patient skin.
• Use on patient with peripheral vascular deficiency.
• Reuse or repositioning of Ground Pad.
• Entire area of the Ground Pad is not reliably attached to the patient body.
• Ground Pad placement over scar tissue, inflamed skin, adipose tissue, bony prominences, metal prostheses, ECG electrodes and cables, active implanted devices, and areas where fluid may pool.
• Use of Ground Pad not in accordance with RF Generator Operator’s Manual.
• Use of a needle as dispersive electrode since a needle may cause skin burns at the reference site due to high current densities.

G4 Generator

Do not use the G4 Radiofrequency Generator with components, electrodes, and/or RF Cannulae/needles that are not approved by Boston Scientific. The use of non-Boston Scientific approved components could negatively affect the EMC performance of the system or result in EMC non-compliance.

 Prior to each procedure, inspect all cables, electrodes, RF Cannulae, and dispersive electrodes for damage. Check the integrity of the electrode and cable insulation for signs of damage. Such damage could lead to RF Current loss, heating, and burning at undesired locations. A signal of undesired RF Current loss is that unusually high RF Voltage, Current, or Power values are required to achieve a desired electrode tip Temperature.

Avoid electrode tip Temperatures near and above 100 °C, as they may produce focal boiling and charring. Raise the electrode Temperature slowly, particularly with large electrodes. Displayed temperature lags behind the actual temperature due to the thermal mass of the electrode.

The physician should observe and record all Voltage, Current, Power, Temperature and Impedance readings at all times, including when using Auto Ramp or Automatic Temperature Control (“Set Temp” or “Max Temp, see Sections 7.1 & 8.1). This gives the physician a measure of parameter normalcy for a given procedure and electrode size. Any anomalously high Voltage, Currents, Impedance, or Power readings would be apparent and signal possible problems.

Make sure that the wall outlet voltage matches the voltage displayed on the Voltage Selector located on the rear of unit (100, 120, 220, or 240). If not, open the Fuse drawer, remove the Voltage Selector and rotate it to the proper voltage setting.

Disconnect all electrodes, ground pad, and associated cables from the G4 before turning the mains power on or off.

It is recommended the CB112-TC and the SKG Knob be sterilized by steam autoclave. The above parts may be sterilized in a Prevacuum Sterilizer at 132 °C to 135 °C (270 °F to 275 °F) for at least 4 minutes. No other parts may be autoclaved.

 

LCED Electrode

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.

Reuse of the Boston Scientific LCE Electrode may result in device malfunction and or exposure of patient to a non-sterile device. Do not use if the Boston Scientific RF Electrode is defective, or if the package is damaged. Avoid lesion temperatures above 90 °C to avoid focal boiling at the tip.

 

Stereotactic TCD

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.

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.

 

TCN Electrode

Do not use if the electrode is defective or damaged. Discontinue use and contact the Boston Scientific customer support team for further assistance.

 

CSK Electrode

Do not use if the electrode is defective. Discontinue use and contact the Boston Scientific customer support team for further assistance.

 

CC-RFK RF Cannula SOURCE

Do not use if the RF Cannula is defective or if its packaging is damaged.

 

RF Single-Use Electrodes and Needles

Do not use if the Boston Scientific RF Injection Electrode is defective.

 

Flextrode Electrode and Cannula

Do not use if the Boston Scientific RF Electrode is defective.

 

RCE Electrode and Cannula

Do not use if the RCE RF Injection Electrode is defective.

 

SideKick 2 Cannula

Do not use if the SideKick 2 Cannula is defective. Do not use if the package is damaged or unintentionally opened before use. Do not use if labeling is incomplete or illegible.

G4 Generator

Reported adverse events or complications for RF heat lesions procedures include, but are not limited to, the following: Temporary motor deficit, post-operative pain, skin burns. Refer to the instructions for use for electrode kits used with the generator for additional adverse events that have been reported for specific RF applications.

 

LCED Electrode

The following adverse events or complications are possible with this procedure:

• Additional Intervention Required
• Allergic Reaction
• Burns
• Cerebrospinal Fluid (CSF) Leak
• Death
• Discomfort
• Headache
• Hematoma
• Hypotension
• Infection
• Nerve Injury
• Overstimulation of Tissue
• Pain
• Paralysis
• Post-Surgical Confusion
• Postural-Gait Disturbance
• Respiratory Failure
• Restlessness
• Stimulation-Related Undesired Sensations
• Tremor
• Urinary Retention

 

Stereotactic TCD

The following adverse events or complications are possible with this procedure:

• Additional Intervention Required
• Akinetic Crisis
• Allergic Reaction
• Burns
• Cerebrospinal Fluid (CSF) Leak
• Cerebral Vascular Accident (CVA)
• Cognitive Deficit
• Death
• Depression
• Discomfort
• Dystonia
• Emotional Reactivity
• Headache
• Hematoma
• Hypotension
• Infection
• Nerve Injury 
• Neurosurgery/Anesthesia Risks
• Overstimulation of Tissue
• Pain
• Paralysis
• Post-Surgical Confusion
• Postural-Gait Disturbance
• Respiratory Failure
• Restlessness
• Seizure
• Speech Disorders
• Stimulation-Related Undesired Sensations
• Swallowing Disorders
• Tremor
• Urinary Retention
• Visual Disturbances
• Weight Fluctuations

 

TCN Electrode

Risks associated with use of TCN Electrodes for the ablation of peripheral nerve tissue include but are not limited to:

• Allergic reactions
• Unintentional burns
• Bleeding
• Device failure
• Increased pain
• Infection
• Need for additional treatment
• Nerve injury
• Paralysis
• Tissue/visceral injury
• Death

 

CSK Electrode

Risks associated with use of CSK Electrodes for the ablation of peripheral nerve tissue include but are not limited to:

• Allergic reactions
• Unintentional burns
• Bleeding
• Device failure
• Increased pain
• Infection
• Need for additional treatment
• Nerve injury
• Paralysis
• Tissue/visceral injury
• Death

 

CC-RFK RF Cannula SOURCE

The following adverse events or complications are possible with this procedure: temporary motor deficit, post-operative pain, and skin burns.

 

RF Single-Use Electrodes and Needles

The following adverse events or complications are possible with this procedure: temporary motor deficit and post-operative pain.

 

Flextrode Electrode and Cannula

The following adverse events or complications are possible with this procedure: temporary motor deficit and post-operative pain.

 

RCE Electrode and Cannula

The following adverse events or complications are possible with this procedure: temporary motor deficit and post-operative pain.

 

SideKick 2 Cannula

Risks associated with the use of the SideKick 2 Cannula for the ablation of peripheral nerve tissue include but are not limited to:

• Additional treatment needed due to device failure or inadequate effectiveness
• Allergic reaction or inflammation
• Infection
• Burns
• Bleeding, bruising, or swelling
• Nerve or tissue injury causing problems related to the area of treatment, e.g. numbness, paralysis
• Pain, discomfort, stiffness, spasms, or other undesired sensations
• Risks related to having a surgical procedure/anesthesia, e.g. respiratory or cardiovascular problems, exposure to biohazardous material, death