Safety Information

The following information provides only some of the safety information related to neurostimulation systems. See the appropriate ANS user’s manual for detailed disclosure about any specific ANS device.

Indications for Use

The neurostimulation systems, Genesis®, GenesisXP™, GenesisRC™, and Eon™, 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 any of the following: failed back surgery syndrome, and intractable low back and leg pain.
The Renew™ neurostimulation system is indicated for spinal cord stimulation (SCS) in the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent or as an adjunct to other modes of therapy used in a multi-disciplinary approach.

Contraindications

The system is contraindicated for patients with demand-type cardiac pacemakers. Also, if you are unable to operate the system or fail to receive effective pain relief during trial stimulation, you should not be implanted with an SCS system.

Warnings

This section lists the potential hazards associated with SCS that you must be aware of to avoid serious outcomes that may cause injury or death. You should not use SCS if you are a poor surgical risk, or have multiple illnesses or active general infections.

Diathermy Therapy—You cannot have any short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on your body if you have any part of a spinal cord stimulator implanted. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it may also damage the neurostimulation system components, resulting in loss of therapy, requiring additional surgery for system replacement. Injury or damage can occur during diathermy treatment regardless of whether the neurostimulation system is turned on or off. You are advised to inform your health-care professional that you cannot be exposed to diathermy treatment.

Operation of Machines, Equipment, and Vehicles—Do not drive or operate heavy machinery or power tools with the neurostimulator turned on. Postural changes or abrupt movements could cause over-stimulation (experienced as a jolting sensation) that might cause you to lose control of your vehicle or equipment.

Magnetic Resonance Imaging (MRI)—You should not be subjected to an MRI. The electromagnetic field generated by an MRI may dislodge implanted components, damage the device electronics, and induce voltage through the lead that could cause a jolting or shocking sensation.

Theft Detectors and Metal Screening Devices—Certain types of anti-theft devices, such as those used at entrances/exits of department stores, libraries, and other public establishments, and security screening devices, like those used at airports, may affect stimulation. It is possible that patients who are implanted with non-adjacent multiple leads or patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which has been described by some as uncomfortable or jolting. It is recommended that anyone with a neurostimulator use caution when approaching such a device and request assistance to bypass the device. If the device cannot be bypassed,  turn off the neurostimulator, proceed with caution, and move through the device quickly.
Lead Movement—Avoid bending, twisting, stretching, or lifting objects over five pounds for six to eight weeks post-implantation. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation.

Explosive or Flammable Gases—Do not use the programmer/transmitter in an environment where explosive or flammable gasses are present.

Cardiac Pacemakers—Implanted neurostimulation systems may adversely affect the operation of implanted cardiac demand pacemakers.

Pediatric Use—Safety and effectiveness of SCS has not been established for pediatric use.
Pregnancy—Safety for use during pregnancy has not been established.

Cardioverter Defibrillators—Neurostimulation systems may adversely affect the programming of implanted cardioverter defibrillators.

Postural Changes—Changes in posture or abrupt movements can change the level of stimulation and potentially cause unpleasant sensations. Turn your IPG off or lower the amplitude before stretching, lifting your arms over your head, or exercising. If unpleasant sensations occur, the IPG should be turned off.

Precautions

This section lists the actions you should be aware of and avoid to prevent situations that may cause uncomfortable sensations or damage to your neurostimulation system.

Keep the Programmer/Transmitter Dry—Do not use the programmer/transmitter when engaging in activities that might cause the programmer to get wet, such as exposure to rain, swimming, and bathing. Your programmer is not waterproof and should be kept dry to avoid damage.

Handle the Programmer/Transmitter With Care—The programmer/transmitter is a sensitive electronic device that can be damaged by rough handling, including dropping on the ground or being crushed.

Battery Care—Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire.

Disconnecting the Wand/Antenna—Do not pull directly on the cord to disconnect the wand/antenna from the programmer/transmitter. Doing so can damage the cord and make the wand/antenna inoperable. To disconnect the wand/antenna, grasp the connector at the contoured finger grips and pull gently downward.

Medical Tests and Procedures—Before undergoing medical tests or procedures, contact your physician to determine if the procedure will cause you injury or damage your neurostimulation system. Specifically, you should be aware that medical devices such as electrohydraulic lithotriptors, therapeutic x-rays, cobalt machines, and linear accelerators may cause damage to the electronic circuitry of an implanted neurostimulation system.

Electromagnetic Interference (EMI)—Certain commercial electrical equipment (arc welders, induction furnaces, resistance welders), communication equipment (microwave programmers, linear power amplifiers, high-power amateur transmitters), and high-voltage power lines may generate sufficient EMI to interfere with neurostimulation operation if approached too closely. Use caution when approaching such devices and turn your neurostimulator off if you feel any unusual sensations. Do not turn the neurostimulator on again until you are away from the area of EMI interference.
Control of Your Programmer/Transmitter—Keep your programmer/transmitter out of the hands of children in order to avoid the potential of damage or unauthorized change in stimulation parameters.

Physician Instructions—Always follow the programs and therapy instructions established for you by your physician. Failure to do so may cause the therapy to be less effective in providing pain relief.

Unauthorized Programming Changes—Do not make unauthorized changes to physician-established stimulation parameters. If you find yourself in an unfamiliar screen display, press the Previous Screen key.

Case Damage—If the neurostimulator case contains a battery, and it is pierced or ruptured, severe burns could result from exposure to the battery chemicals.

Cellular Phones—The effect of cellular phones on spinal cord stimulators is unknown, and patients should avoid placing cellular phones directly over the device.

High Output Ultrasonics and Lithotripsy—The use of high output devices such as an electrohydraulic lithotriptor may cause damage to the electronic circuitry of an implanted neurostimulator. If lithotripsy must be used, do not focus the energy near the neurostimulator.

Ultrasonic Scanning Equipment—The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted device.

External Defibrillators—The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.

Therapeutic Radiation—Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic x-rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead.

Adverse Effects

The implantation of a neurostimulation system involves risk. In addition to those risks commonly associated with surgery, the following risks are also associated with implantation and/or use of a neurostimulation system:

• Undesirable changes in stimulation (can possibly be related to cellular changes in tissue around electrodes, changes in electrode position, loose electrical connections, and/or lead failure)
• Epidural hemorrhage, hematoma, infection, spinal cord compression, and/or paralysis (can be caused by placing a lead in the epidural space during a surgical procedure)
• Unpleasant sensations or motor disturbances, including movement (can be caused by stimulation at high outputs; and, if unpleasant sensations occur, turn off the neurostimulator immediately)
• Battery failure and/or battery leakage
• Radicular chest wall stimulation
• Cerebrospinal fluid leakage
• Persistent pain at the electrode or neurostimulator site
• Seroma at the implant site
• Lead migration, which can result in changes in stimulation and subsequent reduction in pain relief
• Allergic or rejection response to implant materials
• Implant migration and/or local skin erosion
• Paralysis, weakness, clumsiness, numbness, or pain below the level of implantation

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