The User’s Guide must be reviewed prior to use of the neurostimulation system for detailed disclosure.
St. Jude Medical neurostimulation systems are indicated for spinal cord stimulation (SCS) 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.
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.
You may be implanted with the parts that make up a Magnetic Resonance (MR) Conditional system, which allows you to receive a magnetic resonance imaging (MRI) scan if all the requirements for the implanted parts and for scanning are met. Contact your physician before receiving an MRI scan to find out if you can undergo the procedure and to learn more about any risks. Additionally, before receiving an MRI scan, inform the healthcare professional that you are implanted with a neurostimulation system. If you do not have an MR Conditional system, you cannot receive an MRI.
Do not bring your programmer into the scanner magnet room. It can be affected by the MRI magnet, may present a projectile hazard, and is considered MR Unsafe.
This section lists the potential hazards associated with spinal cord stimulation that you must be aware of to avoid serious outcomes that may cause injury or death.
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 neurostimulation system 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. 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. You are advised to inform your healthcare 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 stimulator turned on. Postural changes or abrupt movements could cause overstimulation (jolting sensation) that might cause you to lose control of your vehicle or equipment.
Lead movement. Avoid bending, twisting, stretching, or lifting objects over five pounds for six to eight weeks postimplantation. 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 patient programmer in an environment where explosive or flammable gases are present.
Pediatric use. Safety and effectiveness of spinal cord stimulation has not been established for pediatric use.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
Cardioverter defibrillators. Neurostimulation systems may adversely affect the programming of implanted cardioverter defibrillators.
Device modification. This equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to St. Jude Medical for service.
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 dry. Your programmer is not waterproof. Keep it dry to avoid damage. Do not use the programmer when engaging in activities that might cause it to get wet, such as swimming or bathing.
Handle the programmer with care. The programmer is a sensitive electronic device that can be damaged by rough handling, such as dropping it on the ground.
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. Do not pull directly on the cord to disconnect the wand from the programmer. Doing so can damage the cord and make the wand inoperable. To disconnect the wand, grasp the connector at the
contoured finger grips and gently pull 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 (for example, arc welders, induction furnaces, resistance welders), communication equipment (for example, microwave programmers, linear power amplifiers, high-power amateur transmitters), and high-voltage power lines may generate sufficient EMI to interfere with neurostimulation system operation if approached too closely. Use caution when approaching such devices, and turn your IPG off if you feel any unusual sensations. Do not turn the IPG on again until you are away from the area of EMI.
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, turn off the IPG.
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 nonadjacent 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. Use caution when approaching such a device and request assistance to bypass the device. If you must proceed through the device, turn off the stimulator and proceed with caution, ensuring to move through the device quickly.
Control of your programmer. Keep your programmer out of the hands of children in order to avoid potential damage or unauthorized change in stimulation parameters.
Physician instructions. Always follow the programs and therapy instructions established for you by your physician. If you do not, the therapy may 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.
Device components. The use of non-St. Jude Medical components with this system may result in damage to the system and increased risk of injury.
Magnet usage. The magnet provided with the system is a high-powered magnet intended for use solely with the system. Keep it away from watches, credit cards, computer disks, and other magnetically sensitive items to avoid damaging them. Always place the keeper bar on the magnet when not in use.
Mobile phones. The effect of mobile phones on implantable neurostimulation systems is unknown; patients should avoid placing mobile 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 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.
In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system:
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.