St. Jude Medical™ Invisible Trial System

Safety and use information

Safety and Use

Find important safety information for our implantable devices and systems.

Important Safety Information

St. Jude Medical™ Invisible Trial System with BurstDR™ Stimulation

Rx Only

Prescription and Safety Information

Read this section to gather important prescription and safety information.

Indications for Use

The St. Jude Medical™ Invisible Trial System is 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 St. Jude Medical™ Invisible Trial System is intended to be used externally with St. Jude Medical-approved trial leads and extensions to deliver trial stimulation for a maximum of 30 days.

Contraindications

This neurostimulation system is contraindicated for patients who are unable to use the system.
Neurostimulation should not be used on patients who are poor surgical risks, such as those with multiple illnesses or active general infections.

Warnings

The following warnings apply to these components.

Other system components. Refer to the individual system component manuals for additional warnings and precautions related to those devices.
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 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.
Explosive or flammable gases. Do not use the stimulator in an environment where explosive or flammable gas fumes or vapors are present, including hyperbaric chambers. The operation of the stimulator could cause them to ignite, causing severe burns, injury or death.
Electrosurgery devices. Electrosurgery devices should not be used in close proximity to an implanted neurostimulation device. Contact between an active electrode and an implanted lead or extension can cause direct stimulation of the tissue at the electrode site and cause severe injury to the patient. If use of electrocautery is necessary, first turn off the neurostimulation system.
Implanted cardiac system. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the functions of the implantable cardiac system.
Magnetic resonance imaging (MRI). Patients with an EPG should not be subjected to MRI. Even if the leads are removed the patient should not have an MRI if any part of a lead is still implanted.
Lead movement. Patients should 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, resulting in overstimulation or ineffective stimulation.
Operation of machines, equipment, and vehicles. Patients should not drive or operate heavy machinery or power tools with the stimulator turned on. Postural changes or abrupt movement could cause overstimulation (jolting sensation) that might cause patients to lose control of their vehicle or equipment.
Postural changes. Changes in posture or abrupt movements can change the level of stimulation and potentially cause unpleasant sensations. Patients should turn stimulation off or lower the amplitude before stretching, lifting their arms over their head, or exercising. If unpleasant sensations occur, turn off stimulation.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
System components. The use of non St. Jude Medical™ components with this system may result in damage to the system and increased risk to the patient.
Power supply. Use only the CR2450 batteries supplied with the device. CR2450 batteries have a nominal voltage of 3V and nominal capacity of at least 600 mAh.

Precautions

The following precautions apply to these components.

General Precautions

Clinician Training. Clinicians should be experienced in implanting neurostimulation devices and should have undergone sufficient surgical and device implantation training.
Patient Selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures and inform patients to avoid showering and touching the bandages.
Theft detectors and metal screening devices. Certain types of antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public establishments, and airport security screening devices may affect stimulation. Patients who are implanted with nonadjacent multiple leads and 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. Patients should use caution when approaching such a device and should request assistance to bypass the device. If they must proceed through the device, patients should turn off the EPG and proceed with caution, being sure to move through the detector quickly.
Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.

Handling and Implementation

Single use only. The EPG header is intended for single use only.
Exposure to liquids. Device components should be stored where they will not be exposed to liquids or excessive moisture, which can damage the package materials and components.
Care and handling of components. Use extreme care when handling system components prior to use. Excessive heat, traction, bending, and twisting, or the use of sharp instruments may damage components and cause them to fail.
Package or component damage. Do not use the device if the package or components show signs of damage. Return any suspect components to St. Jude Medical for evaluation.
System testing. To ensure correct operation, the system should always be tested before the patient leaves the surgery suite.
Device modification. The 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.
Component disposal. Dispose of the EPG header and pouch with other medical waste. Return the EPG to St. Jude Medical for safe disposal when necessary.

Hospital and Medical Environments

Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of a 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, computerized tomography (CT) scans, cobalt machines, and linear accelerators. If radiation therapy is required, disconnect the EPG from the leads or extensions. Damage to the system may not be immediately detectable.
Home and Occupational Environments
Electromagnetic interference (EMI). Certain commercial electrical equipment (for example, arc welders, induction furnaces, and resistance welders), communication equipment (for example, microwave transmitters, linear power amplifiers, and high power amateur transmitters), high voltage power lines, and radio-frequency identification (RFID) devices may generate sufficient EMI to interfere with the operation of the neurostimulation system if approached too closely. Keep the neurostimulation system at least 10 cm (4 in) away from RFID devices.
Mobile phones. The effect of mobile phones on neurostimulation systems is unknown; patients should avoid placing mobile phones directly over the system.

Adverse Effects

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

  • Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off stimulation immediately.)
  • Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure
  • Stimulation in unwanted places
  • Radicular chest wall stimulation
  • Lead migration, causing changes in stimulation or reduced pain relief
  • Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space
  • Cerebrospinal fluid (CSF) leakage
  • Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
  • Persistent pain at the electrode site
  • Seroma (mass or swelling) at the implant site
  • Allergic or rejection response to device materials

St. Jude Medical™ Invisible Trial System with DRG Stimulation

Intended Use

This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The St. Jude Medical™ Patient Controller app is intended to be used with the generator to help the patient manage prescribed stimulation programs.

Indications for Use

This neurostimulation system is indicated for the management of chronic, intractable pain.

Contraindications

This system is contraindicated for patients who are

  • Unable to operate the system
  • Poor surgical risks
  • Pregnant
  • Under the age of 18

MRI Safety Information

If you are using a trial system, you should not be subjected to an MRI. The electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could cause a jolting or shocking sensation. If you are using a permanent system, you may be implanted with the parts that make up a Magnetic Resonance (MR) Conditional system, which allows you to receive an 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 patient controller into the scanner magnet room. It can be affected by the MRI magnet, may present a projectile hazard, and is MR Unsafe.

Warnings

The following warnings apply to these components.

NOTE: For non-therapy related warnings regarding the St. Jude Medical™ Patient Controller, refer to the Apple™ manual available at http://www.apple.com/support/ipodtouch/.

System Warnings

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.
Medical tests and procedures. Before undergoing medical tests or procedures (such as therapeutic radiation or electrolysis), 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, computerized tomography (CT) scans, cobalt machines, and linear accelerators may cause damage
to the electronic circuitry of an implanted neurostimulation system. If using a trial system and radiation therapy is required, disconnect the trial generator from the leads or extensions. Damage to the system may not be immediately detectable.
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.
Electrosurgery devices. Electrosurgery devices may harm you or damage your neurostimulation system. If you need to receive a procedure using an electrosurgery device, place your IPG in Surgery Mode. Your physician may only use bipolar electrosurgery devices and they should keep the device as far away from your neurostimulation system as possible. Additionally, they must confirm the neurostimulation system is functioning correctly after your procedure.
Emergency procedures. Designate a representative (family member or close friend) to notify any emergency medical personnel of your neurostimulation system if emergency care is required. You will receive an identification card to carry that will inform emergency medical personnel of your implanted system. Use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion.
Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of a 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, either disconnect the EPG from the leads or extensions or shield the area over the implanted IPG with lead. Damage to the system may not be immediately detectable.
Component manipulation. Do not rub or press on implanted components through the skin. This may cause the leads to move leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection.
Lead movement. Avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. These activities may cause lead movement, resulting in understimulation or overstimulation. Excessive lead migration may require reoperation to replace the leads.
Operation of machines, equipment, and vehicles. If you feel uncomfortable paresthesia during postural changes do not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Do not climb ladders or participate in activities where postural changes or abrupt movements could cause overstimulation (jolting sensation) and cause you to fall or lose control of equipment or vehicles or injure others.

Additional Warnings Only Applicable to the Trial System

Routine medical procedures. If you are using a trial system, inform your healthcare providers and avoid elective medical procedures.

Additional Warnings Only Applicable to the Permanent System

External defibrillators. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. After defibrillation, confirm the neurostimulation system is still working.
Cardioverter defibrillators. Neurostimulation systems may adversely affect the programming of implanted cardioverter defibrillators.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.
Scuba diving and hyperbaric chambers. Avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage your neurostimulation system.

Device Warnings

Explosive or flammable gases. Do not use an EPG or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Operating these devices could cause them to ignite, causing severe burns, injury, or death.
Interference with other devices. This equipment can radiate radiofrequency (RF) energy that may interfere with other electronic devices. Avoid placing equipment components directly over other electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected.
Device modification. The 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.
Keep the device dry. Your EPG and patient controller devices are not waterproof. Keep them dry to avoid damage. Do not use your device when engaging in activities that might cause it to get wet, such as swimming or bathing.
Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (i.e., jailbroken).
Strangulation. The cords in this system pose a strangulation risk. To avoid strangulation, be careful when using cords and keep cords out of the reach of children.

Precautions

The following precautions apply to these components.

NOTE: For nontherapy related precautions for the St. Jude Medical™ Patient Controller, refer to the Apple™ manual available at http://www.apple.com/support/ipodtouch/.

System Precautions

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.
Patient training. Do not use your neurostimulation system until an authorized clinician has trained you how to control stimulation and safely use the system.
Device components. The use of components not approved for use by St. Jude Medical may result in damage to the system and increased risk of injury.
Infection. Follow proper infection control procedures and avoid showering and touching the bandages.
High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render you incapable of controlling the stimulator. If unpleasant sensations occur, turn off the device immediately.
Postural changes. Changes in posture or abrupt movements can change the level of stimulation and potentially cause unpleasant sensations. Turn stimulation off or lower the stimulation strength before stretching, lifting your arms over your head, or exercising. If unpleasant sensations occur, turn off stimulation.
Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radio-frequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes).
Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)
Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public establishments, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Use caution when approaching such a device and request assistance to bypass the device. If you must proceed through a gate or doorway containing this type of device, turn off stimulation and proceed with caution, being sure to move through the device quickly.
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. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Contact your physician if you are concerned about your mobile phone interacting with your neurostimulation system.
Home use. This product is intended for home use per physician instruction. To avoid damage and other potential hazards, keep this product away from children and pets.
Household appliances. Household appliances that contain magnets (such as refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator.

Additional Precautions Only Applicable to the Trial System

Battery damage. If the internal batteries are shorted, it is possible for the external temperature of the pouch to reach 42°C (107°F), which could damage the EPG. If this occurs, contact your clinician.

Additional Precautions Only Applicable to the Permanent System

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 device. If lithotripsy must be used, do not focus the energy near the device.
Overcommunicating with the IPG. Use your patient controller to communicate with your IPG only when needed because excessive communication with the IPG can shorten the remaining battery life.

Device Precautions

Handle the device with care. The patient controller is a sensitive electronic device that can be damaged by rough handling, such as dropping it on the ground.
Battery precaution. The patient controller contains a lithium ion battery as well as other potentially hazardous materials. Do not crush, puncture, or burn the device because explosion or fire may result. Return it to St. Jude Medical for proper disposal.
Control of your device. Keep your patient controller out of the hands of children in order to avoid potential damage or unauthorized change in stimulation parameters.

Adverse Effects

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

  • Unpleasant sensations or motor disturbances,including involuntary movement, caused bystimulation at high outputs (if either occurs, turnoff stimulation immediately)
  • Undesirable changes in stimulation, which maybe related to cellular changes in tissue around theelectrodes, changes in electrode position, looseelectrical connections, or lead failure or breakage
  • Stimulation in unwanted places (such asstimulation of the chest wall)
  • Lead migration, causing changes in stimulation orreduced pain relief
  • Epidural hemorrhage, hematoma, infection, spinalcord compression, or paralysis from placement ofa lead in the epidural space
  • Cerebrospinal fluid (CSF) leakage
  • Tissue damage or nerve damage
  • Paralysis, weakness, clumsiness, numbness,sensory loss, or pain below the level of the implant
  • Pain or bleeding where the needle was inserted
  • Persistent pain at the electrode or IPG site
  • Escalating pain
  • Seroma (mass or swelling) at the implant site
  • Headache
  • Allergic or rejection response to device or implantmaterials
  • Implant migration or skin erosion around theimplant
  • Battery failure, leakage, or both
  • Hardware malfunction that requires replacing theneurostimulator
  • Pain from a noninjurious stimulus to the skin oran exaggerated sense of pain

Additional risks, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. This may occur once the lead is in place and is connected to the neurostimulator and activated. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings.

If you have any concerns about your neurostimulation system, contact your doctor during normal business hours.