*BurstDR™ stimulation, patented technology exclusively from St. Jude Medical, is also referred to as Burst stimulation in clinical literature.
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Prescription and Safety Information
Read this section to gather important prescription and safety information.
Intended Use: This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.
Indications for Use: This neurostimulation 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 the following: failed back surgery syndrome and intractable low back and leg pain.
Contraindications: This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.
MRI Safety Information Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at manuals.sjm.com). For more information about MR Conditional products, visit the St. Jude Medical product information page at sjmprofessional.com/MRI.
The following warnings apply to these components.
Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.
Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by St. Jude Medical. Physicians should also discuss any risks of MRI with patients.
Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.
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 systemimplantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.
Electrosurgery devices.Electrosurgery devices should not be used in close proximity to an implanted neurostimulation system. Contact between an active electrode and an implanted IPG, lead, or extension can cause severe injury to thepatient. If use of electrocautery is necessary, first turn off the neurostimulation system.
Implanted cardiac systems. 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 function of the implantable cardiac system.
Operation of machines, equipment, and vehicles. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. However, current data shows that most patients using BurstDR™ stimulation therapy do not experience paresthesia. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment.
Burst stimulation during the trial period. The use of BurstDR stimulation during the trial period has not been evaluated for effectiveness.
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.
Device components. The use of components not approved for use by St. Jude Medical may result in damage to the system and increased risk to the patient.
Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.
IPG disposal. Return all explanted IPGs to St. Jude Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.
The following precautions apply to these components.
Clinician 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 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. Infections related to system implantation might require that the device be explanted.
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. Patients should avoid getting too closeto 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, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
Theft detectors and metal screening devices. Certain types ofantitheft devices, such as those used atentrances 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 IPG and proceed with caution, being sure to move through the detector quickly.
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.)
Mobile phones. The effect of mobile phones on neurostimulation systems is unknown; patients should avoid placing mobile phones directly over the system.
Sterilization and Storage:
Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.
Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind.
Handling and Implementation:
Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system 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 or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to St. Jude Medical for evaluation.
System testing. To ensure correct operation, the system should always be tested after implantation and 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.
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 system.
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. Damage to the system may not be immediately detectable
In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this IPG:
- Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.)
- Stimulation in unwanted places
- Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
- Persistent pain at the IPG site
- Seroma (mass or swelling) at the IPG site
- Allergic or rejection response to implant materials
- Implant migration or skin erosion around the implant
- Battery failure
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