Product Safety Information

Nalu Neurostimulation System and Safety Information

INDICATIONS FOR USE

Spinal Cord Stimulation (SCS)

This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Peripheral Nerve Stimulation (PNS)

This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region.

The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

SAFETY INFORMATION

Contraindications

Users contraindicated for this therapy are those who:

Are unable to operate the system
Have failed trial stimulation by failing to receive effective pain relief
Are poor surgical risks
Are pregnant

Exposure to shortwave, microwave, or ultrasound diathermy – Diathermy should not be operated within the vicinity of a patient implanted with a Nalu Neurostimulation System or when wearing a Therapy Disc. The energy from diathermy can be transferred through the stimulator and cause tissue damage, resulting in severe injury.

Occupational exposure to high levels of non-ionizing radiation that may interfere with therapy – Patients who regularly work in environments with elevated levels of non-ionizing radiation should not be implanted with the device. The energy in high-level areas can be transferred through the device and cause tissue damage, resulting in severe injury. Examples of environments having high level non-ionizing radiation include the following:

Radio or cell phone transmission stations
Facilities using radiofrequency heat sealers or induction heaters
Electric power infrastructure controlled environments (i.e. step down transformers or high voltage power lines)

Implanted Cardiac or Other Neurostimulation Systems—Patients who have implanted cardiac or other neurostimulation systems should not use the Nalu Neurostimulation System. Electrical pulses from the Nalu Neurostimulation System may interact with the sensing operation of an implanted cardiac or neurostimulation system, causing the system to respond inappropriately.

Warnings

Electromagnetic Interference (EMI)—EMI is a field of energy generated by equipment found in the home, work, medical, or public environments. Very strong EMI can interfere with the System. The device includes features that provide protection from EMI. Most electrical device and magnets encountered in a normal day will not affect the operation of the System, however, strong sources of EMI could result in the following:

Serious user injury resulting from heating of the implanted device and damage to surrounding tissue.
System damage resulting in a loss of, or change in, symptom control that might require additional surgery.
Operational changes to the Therapy Disc. This may cause the external device to turn on, turn off, or reset to factory settings. If this occurs, the Therapy Disc needs to be reprogrammed.
Unexpected changes in stimulation, causing a momentary increase in stimulation or intermittent stimulation. Some users have described a jolting or shocking sensation. Although the unexpected change in stimulation may feel uncomfortable, it will not damage the device or cause direct injury to the user. In rare cases, as a result of the unexpected changes in stimulation, users have fallen down and been injured.

If you suspect that your Nalu Neurostimulation System is being affected by EMI, then you should:

For the Therapy Disc – Remove or Turn Off
For the Trial Therapy Disc – Disconnect and/or Turn Off Stimulation
Immediately move away from the equipment or object.

Electromagnetic Equipment/ Environments—Avoidance of high electromagnetic equipment radiators or environments is highly encouraged. Examples of equipment and/or environments include the following:

High-power amateur transmitters/antennas or citizen band (CB) radio or Ham radio used for private recreation, communication, and wireless experimentation.
Electric arc welding or resistance welding equipment used for melting and joining metals or plastics.
Industrial electric induction furnace/heater or electric arc furnace/heater used for melting metals and plastics.
High-voltage areas identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area).
Microwave transmitters identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area).
Television, cell phone and radio towers identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area).
Linear power amplifiers used for increasing the power output of radio transmitters, wireless communication applications, audio equipment or other electronic equipment.
Radio telemetry equipment used for tracking location of vehicles, equipment or animals.

Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Nalu Neurostimulation System. Otherwise, performance degradation of the equipment might occur.

Machinery or Heavy Equipment—Machinery and heavy equipment (including vehicles) should not be operated while using the Nalu Neurostimulation System. Malfunction of the System could result in the loss of body control, body function, or a feeling that could render the user incapable of controlling the equipment.

Theft Detectors and Metal Screening Devices – Certain types of antitheft devices, such as those used at the entrances/exits of department stores, libraries, and other public establishments, and/or airport security screening devices may affect stimulation. If you are sensitive to low stimulation thresholds, you may experience a momentary increase in perceived stimulation, which has been described 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, remove the Therapy Disc and proceed with caution, but be sure to move through the detector quickly.

Temperature Rise During Stimulation – During prolonged use of Therapy Disc the temperature of the device may rise by 1°C above ambient temperature. If the Therapy Disc becomes uncomfortable remove the device from the clip and discontinue use.

When you are considering additional medical tests or treatments, please share the following Warnings with your clinician.

Active Implantable or Body-Worn Medical Devices—Safety has not been established for users who use the Nalu Neurostimulation System with other active implantable or body-worn medical devices. Malfunction and/or damage could occur to either system that could result in harm to the user or other people nearby

Magnetic Resonance Imaging (MRI)—MR Unsafe – For the Nalu Neurostimulation System, the only components that are allowed into the MRI system room are the 40 cm Lead (Model 12001-040), the Nalu Anchor (Model 13001) and the Nalu Implantable Pulse Generators (Model 11001-040, 11002-040, 11003-002, 11004-002).

All other components (i.e., the external component and programmer) are MRI Unsafe and not permitted in the MRI system room.

Magnetic Resonance Imaging (MRI) – MR Conditional – Prior to conducting or recommending an MRI examination on a patient with the Nalu Neurostimulation System, it is important to read and understand the entire section entitled, “MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION” in the Table of Contents, which pertains to performing an MRI examination safely in a patient.

These instructions apply only to the Nalu Neurostimulation System and do not apply to other products. If you have any questions, please contact Nalu Medical or visit Nalu’s website www.nalumed.com.

The only Nalu Medical components that are labeled and approved as MR Conditional are the Lead (Model 12001-040), the Nalu Anchor (Model 13001) and the Nalu Implantable Pulse Generators (Model 11001-040, 11002-040, 11003-002, 11004-002). All other components are MR Unsafe.

Computed Tomography (CT) Scanning—Safety has not been established for CT scanning of users with a Nalu Neurostimulation System. X-rays from the scan could cause unintended shocks or malfunctions of the System, and may not be immediately detectable.

The CT operator should use CT scout views to determine if implanted medical devices are present and their location relative to the programmed scan range. For CT procedures in which the device is in or immediately adjacent to the programmed scan range, the operator should:
1. Remove the Therapy Disc from the CT scan range.
2. Minimize X-ray exposure to the implanted device by:
3. Using the lowest possible X-ray tube current consistent with obtaining the required image quality.
4. Making sure that the X-ray beam is not placed over the Nalu Implantable Pulse Generator for more than a few seconds.
After CT scanning directly over the implanted device:
1. Place the Therapy Disc on body/connect the Trial Therapy Disc and turn on stimulation.
2. Check for proper stimulation, and that indicator lights are operating as expected.
3. Shut off the Therapy Disc if it is suspected that the device is not functioning properly.

Radiofrequency (RF) Ablation—Safety has not been established for RF ablation in users with the device. RF ablation may result in heating and tissue damage. Do not use RF ablation anywhere near the device. If RF ablation is used, ensure that ablation is not performed over or near the device.

Medical Devices/Therapies— The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the Nalu Implantable Pulse Generator particularly if used in close proximity to the device:

Lithotripsy
Do not use monopolar cautery
External defibrillation
Radiation therapy
Ultrasonic scanning
High-output ultrasound
Bone growth stimulators
Dental Drills and Ultrasonic Probes
Electrolysis
Laser Procedures
Radiation Therapy
TENS (transcutaneous electrical nerve stimulation)

If the user is required by medical necessity to undergo any of the above therapies or procedures, the procedural guidelines below must be followed. Ultimately, however, the device may need to be explanted as a result of associated failure. Turn off stimulation of the Nalu Implantable Pulse Generator before the procedure or therapy.

All equipment, including ground plates and paddles, must be used as far away from the Implantable Pulse Generator as possible.
Bipolar electrocautery is recommended. Do not use monopolar electrocautery.
Every effort should be taken to keep fields, including current, radiation, or high-output ultrasonic beams, away from the Implantable Pulse Generator.
If radiation therapy is required, the area over the Nalu Implantable Pulse Generator should be shielded with Lead.
Equipment should be set to the lowest energy setting clinically indicated.
Instruct users to confirm Implantable Pulse Generator functionality following treatment by turning on the Implantable Pulse Generator and gradually increasing stimulation to the desired level.
Damage from these procedures to the Nalu Neurostimulation System may not be detected immediately.

Psychotherapeutic Procedures—Safety has not been established for psychotherapeutic procedures using equipment that generates electromagnetic interference (e.g., electroconvulsive therapy, transcranial magnetic stimulation) in users who have spinal cord stimulators. Induced electrical currents can cause heating that may result in tissue damage.

Other Medical Procedures—EMI from the following medical procedures is unlikely to affect the device:

Diagnostic x-rays or fluoroscopy
Magnetoencephalography (MEG)
Positron emission tomography (PET) scans
Therapeutic magnets (e.g., magnetic mattresses, blankets, wrist wraps, elbow wraps)

Painful Stimulation—If the user experiences painful stimulation do the following:

For Therapy Disc – Remove or decrease the stimulation amplitude

For Trial Therapy Disc – Disconnect or decrease the stimulation amplitude Contact your clinician if this continues to occur.

Strangulation— Entanglement in the Therapy Disc Charger cable, Electrode Interfacing Cable, or Relief Belt may cause a fall or strangulation.

Tampering – Do not modify or tamper with any component of the Nalu Neurostimulation System. Tampering with the device could result in harm. If the device is not working properly, contact your clinician for help.

Precautions

Clinician Training – If you have a Nalu Neurostimulation System, please inform your regular clinician or specialist.

Your clinician should visit www.nalumed.com for more information about the system prior to any medical procedures.

Clinician Instructions– Always follow the programs and therapy instructions established by your clinician. Failure to do so may cause the therapy to be less effective in providing pain relief.

Post-Operative— During the two weeks following surgery, it is important to use extreme care so that appropriate healing will secure the implanted components and close the surgical incisions:

Do not lift objects of more than five pounds.
Do not engage in rigorous physical activity such as twisting, bending, or climbing.
If new Leads were implanted, do not raise your arms above your head.

Temporarily, there may be some pain in the area of the implant as the incisions heal. If discomfort continues beyond two weeks, contact your clinician.

If you notice excessive redness around the wound areas during this time, contact your clinician to check for infection and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this period.

Be sure to consult your clinician before making lifestyle changes due to decreases in pain.

Medical Tests and Procedures – Before undergoing medical tests or procedures, contact your clinician to determine if the procedure will cause damage to the user or to the System.

The following precautions should be followed to properly use and care for your Therapy Disc and/or Trial Therapy Disc:

Use the Therapy Disc as Directed – Use the Therapy Disc only as explained your clinician or as discussed in the User Manual. Using the Therapy Disc in any other manner could result in harm. Do not use any equipment or accessories that are not supplied with the Therapy Disc.

Use of Another User’s Therapy Disc – Use of another user’s Therapy Disc will not deliver therapy. The therapy programmed is a unique prescription for each user and their specific Nalu Implantable Pulse Generator.

Handle the Therapy Disc with Care – The Therapy Disc is a sensitive electronic device. Avoid dropping the device onto hard surfaces. Keep the Therapy Disc out of the reach of children, pests and pets.

Keep the Trial Therapy Disc Dry – The Trial Therapy Disc is not waterproof. Keep the Trial Therapy Disc dry to avoid damage.

Avoid extended immersion with the Therapy Disc – The Therapy Disc can get wet within certain limits. It is not recommended that the Therapy Disc be used during water activities. Upon shipment, the Therapy Disc is rated IP67 (protected from total dust ingress, protected from immersion between 15 centimeters and 1 meter in depth for 30 minutes) and over time with normal wear and use, the Therapy Disc may become more susceptible to damage by immersion.

Clean the Therapy Disc – When needed, clean the outside of the Therapy Disc with a damp cloth to prevent dust and dirt.

Storage Temperatures – The Nalu Neurostimulation System should be kept within the storage temperatures listed on product packaging. Exceeding the storage temperature can affect the performance of the device.

Random Component Failure – Although unlikely, a failure of the Nalu Neurostimulation System is possible due to random component failure. If any part of your Neurostimulation System stops working or changes how it works, remove the Therapy Disc and contact your Nalu representative.

Unexpected Changes in Stimulation – Electromagnetic interference, changes in posture, and other activities can cause a perceived increase in stimulation. Some users have described this as a jolting or shocking sensation. Before engaging in potentially unsafe activities you should do the following:

For Therapy Disc – Remove or Turn Off
For Trial Therapy Disc – Disconnect and/or Turn Off Stimulation

Airline Policies – Follow airline policies for use of medical spinal cord stimulation systems and electronic equipment during flights. Refer all questions to airline personnel. Carry your ID card with you at all times.

Flammable or Explosive Environments – Do not use the Therapy Disc in flammable or explosive environments. Using the Therapy Disc in one of these environments could result in harm.

Activities Requiring Excessive Twisting or Stretching – Avoid activities that could potentially put stress on the device. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching can cause your stimulator to fracture or migrate. This can result in a loss of stimulation, intermittent stimulation, and additional medical procedures.

Scuba Diving or Hyperbaric Chambers – Do not dive below 13 meters (45 feet) of water or enter hyperbaric chambers above 1.48 atmospheres absolute (ATA) with the Nalu Implantable Pulse Generator. These conditions can damage the device. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with the clinician. Do not dive or enter hyperbaric chambers with the Therapy Disc.

Remote Control Interference– If interference is suspected during use of the remote control, confirm that the Bluetooth data transmission is operating properly. If the Nalu Remote Control application is not connecting to the Therapy Disc:

Terminate the current stimulation program and shut down the Nalu Remote Control application.
Check for sources of Bluetooth interference in the surrounding area.
Remove or turn off the source of interference.
Re-establish the Bluetooth link with the Therapy Disc through pairing.
Reopen the Nalu Remote Control application and resume the therapy.

Adverse Environments – Any user with a Nalu Neurostimulation System should seek medical guidance before entering environments which could adversely affect the operation of the Nalu Neurostimulation System, including areas protected by a warning against entry by users.

Adverse Event Summary

Undesirable changes in stimulation sensation and/or location with or without user movement.
Persistent post-surgical pain at hardware implantation sites.
Seroma or hematoma at surgery sites.
Spinal cord injury and or compression with subsequent neurological deficits – permanent or temporary.
Lead migration, causing the electrodes to move from the intended location.
Implantable Pulse Generator migration, which may or may not require surgical intervention.
Fracture of the lead(s) or failure of other system components, which may result in the loss of stimulation or untoward stimulation induced dysesthesias.
Allergic or rejection reaction to the anesthesia, implanted components, or external components.
Reaction to the selected antibiotics or to the Nalu device including: rash, diarrhea, abdominal pain, nausea /vomiting, dizziness, headaches, hypersensitivity (allergic) reactions
Undesirable skin problems such as infection, irritation, blistering, tearing or allergic reactions that may occur during the use of any wearable component of the Nalu Neurostimulation System.
Skin irritation, including redness, itchiness, and bumpiness
Infection at implant site that may or may not require hospitalization and require treatment with antibiotic therapy or surgical intervention
Cerebral spinal fluid (CSF) leak inclusive of those requiring active medical intervention.
Inadequate pain relief or increase in pain following system implantation
Wound complications that may require medical intervention inclusive of surgical management.
Thromboembolic events requiring medical intervention; inclusive of deep vein thrombosis and pulmonary embolism.
Death and/or catastrophic neurological complications.
Anesthetic complications – e.g. nausea, urinary retention.
Excessive fibrotic reaction to device leading to pain and/or new pain symptoms.
Unexpected stimulation effects including but not limited to: chest wall stimulation, muscle stimulation, tremor, dyskinesia, superficial pain, cramping, light-headedness and metallic taste.
Tissue damage.
Nerve damage.
Sensory loss.
Discomfort during the treatment.
Skin erosion around the Nalu Implantable system or at the site of the Nalu wearable devices.
Battery failure.
Lead breakage requiring replacement of the Lead.
Electromagnetic interference causing a change in System performance.
Loss of therapeutic effect despite a functioning system.
Hardware malfunction requiring replacement of the neurostimulator components.
Pain from a non-injurious stimulus to the skin (allodynia).
An exaggerated sense of pain (hyperesthesia).
Change in stimulation that are possibly related to tissue changes around the electrodes, shifts in electrode position, loose electrical connections, and lead or extension fractures which have been described by some users as uncomfortable stimulation (a jolting or shocking sensation).
Formation of reactive tissue in the epidural space around the lead can result in delayed spinal cord compression and paralysis, requiring surgical intervention. Time to onset can range from days to many years after implant.
Cardiac arrest.
Intracranial hypotension.
Fracture of the lead(s) or failure of other system components.
Loss of therapy or unpleasant paresthesia.

Adverse effects of stimulation are usually mild and go away when stimulation is turned off. Contact your clinician immediately if you experience any problems. There may be changes in the level of pain control over time.

Notice: In the event of any serious incident that has occurred in relation to the Nalu Neurostimulation System, the user should report the incident to Nalu Medical at +1.800.618.3402 or visit www.nalumed.com.