The following is a brief summary. The Clinician’s Manual must be reviewed prior to use of the IPG Neurostimulation System for detailed disclosure.

Indications for Use

The Genesis, GenesisXP, GenesisRC and Eon (IPG) Neurostimulation Systems are indicated as aids 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. Certain Renew Neurostimulation System models are also indicated to stimulate electrically peripheral nerves to relieve severe intractable pain.

Contraindications

The system is contraindicated for patients with demand-type cardiac pacemakers.

Patients who are unable to operate the system or who fail to receive effective pain relief during trial stimulation cannot be implanted with a neurostimulation system.

Warnings

Spinal cord stimulation (SCS) should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

Diathermy therapy—Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. 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. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. All patients are advised to inform their health care professional that they should not be exposed to diathermy treatment.

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

Magnetic Resonance Imaging (MRI)—Patients with implanted neurostimulation systems should not be subjected to MRI. The electromagnetic field generated by an MRI may forcefully dislodge implanted components, damage the device electronics, and induce voltage through the lead that could jolt or shock the patient.

Explosive or flammable gases—Do not use the patient programmer in an environment where explosive or flammable gas fumes or vapors are present. The operation of the patient programmer could cause them to ignite, causing severe burns, injury, or death.

Theft detectors and metal screening devices—Certain types of antitheft devices, such as those used at entrances/exits of department stores, libraries, and other public establishments, and/or airport security screening devices may affect stimulation. It is possible that patients who are implanted with non-adjacent multiple leads and/or patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which has been described by some patients as uncomfortable or jolting. It is recommended that patients use caution when approaching such a device and that they request assistance to bypass the device. If they must proceed through the device, the patient should turn off the stimulator and proceed with caution, ensuring to move through the detector quickly.

Lead movement—Patients should be instructed to 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.

Operation of machinery and equipment—Patients should not operate potentially dangerous machinery, power tools, or vehicles or climb ladders, etc., when the IPG is operating. Postural changes or abrupt movement could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves.

Postural changes—Changes in posture or abrupt movements may result in a decrease or increase in the perceived level of stimulation. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Patients should be advised to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting of arms over head, or exercising. If unpleasant sensations occur, the IPG should be turned off immediately.

Pediatric use—Safety and effectiveness of spinal cord stimulation have not been established for pediatric use.

Pregnancy—Safety for use during pregnancy has not been established.

Device components—The use of non-ANS components with this system may result in damage to the system and increased risk to the patient.

Case damage—If the IPG case is pierced or ruptured, severe burns could result from exposure to the battery chemicals.

Single-use device—The implanted components of an ANS neurostimulation system are intended for a single use only. Do not resterilize or reimplant an explanted system for any reason due to the risk of infection and device malfunction.

Precautions

GENERAL PRECAUTIONS

Physician training—Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.

Patient selection—It is extremely important to appropriately select patients for spinal cord stimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the stimulator.

Infection—It is important to follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.

Implantation of two systems—If two systems are implanted, ensure that at least 8 in. (20 cm) separates the implanted IPGs to minimize the possibility of interference during programming.

Implantation of multiple leads—If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads have the possibility of creating a conduit for stray electromagnetic energy that could cause unwanted stimulation in the patient.

Implant location—While testing has shown no risk of excessive heating during IPG recharging, when determining IPG implant location in patients with areas of reduced sensitivity to heat, consider placing the implant where the patient has normal sensation.

High stimulation outputs—Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient programmer. If unpleasant sensations occur, the device should be turned off immediately.

Stimulation parameters—Patients should be cautioned that stimulation parameters must be determined under the supervision of a physician and that they should not adjust stimulation parameters within prescribed programs except under direct orders from their physician.

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

STERILIZATION AND STORAGE

Storage temperature—Store system components between -10°C (14°F) and 55°C (131°F), because temperatures outside this range can damage components.

Storage humidity—Store components between 10% and 90% humidity.

HANDLING, IMPLEMENTATION, AND EXPLANTATION

Expiration date—Do not implant a device if the use-before date has expired.

Care and handling of components—Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

Package and component damage—Do not implant a device if the sterile package or components show signs of damage, the sterile seal is ruptured, or if contamination is suspected for any reason. Return to ANS for evaluation.

Exposure to body fluids or saline—Prior to connection, exposure of the metal contacts, on the connection end of the lead or extension, to body fluids or saline can lead to corrosion. If this occurs, clean with sterile deionized water or sterile water for irrigation and dry completely prior to lead connection and subsequent implantation.

System testing—The operation of the system should always be tested after implantation and before the patient leaves the surgery suite to assure correct operation.

Component disposal—Return all explanted components to ANS for safe disposal.

HOSPITAL AND MEDICAL ENVIRONMENTS

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 IPG. If lithotripsy must be used, do not focus the energy near the IPG.

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.

Electrosurgery devices—Electrosurgery devices should not be used in close proximity to an implanted neurostimulation IPG or lead. Contact between an active electrode and an implanted IPG, lead, or extension can cause direct stimulation of the spinal cord and cause severe injury to the patient. If use of electrocautery is necessary, turn the IPG off.

HOME AND OCCUPATIONAL ENVIRONMENTS

Electromagnetic interference (EMI)—Certain commercial electrical equipment (e.g., arc welders, induction furnaces, resistance welders), communication equipment (e.g., microwave transmitters, linear power amplifiers, high power amateur transmitters), and high voltage power lines may generate sufficient EMI to interfere with the neurostimulation system operation if approached too closely.

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 may occur over time. These changes in stimulation are possibly related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections,
and/or lead failure.

● Placement of a lead in the epidural space is a surgical procedure that may expose the patient to risks of epidural hemorrhage, hematoma, infection, spinal cord compression, and/or paralysis.

● Battery failure and/or battery leakage may occur.

● Radicular chest wall stimulation.

● CSF leakage.

● Persistent pain at the electrode or IPG 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.