Intended Purpose/Indication for ReActiv8

The ReActiv8 System is indicated for bilateral stimulation of the medial branch of the dorsal ramus as an aid in the management of mechanical chronic low back pain associated with multifidus muscle dysfunction, in adults who have failed therapy including pain medications and physical therapy and are not candidates for spine surgery.

Contraindications 

ReActiv8 is contraindicated for patients who are: 

• Unable to operate the system Impaired shoulder mobility limiting the ability to place the activator antenna over the IPG 
• Evidence of cognitive impairment that limits the patient’s ability to operate the device 

Unsuitable for ReActiv8 implant surgery, for reasons such as: 

• The patient has an active infection in the vicinity of the surgical site, or any systemic infection 
• The patient is on blood thinners and unable to be temporarily discontinued for the surgical procedure

Possible benefits of ReActiv8* 

The possible benefits associated with ReActiv8 include: 

• Reduction in the severity of your low back pain; 
• Improvement in your ability to handle regular daily activities (reduction of disability); and 
• Improvement in your quality of life. 

*For details related to the possible benefits of ReActiv8, refer to the ReActiv8 Summary of Safety and Clinical Performance (SSCP). A copy of the SSCP) can be viewed by searching the device brand name on the Eudamed website at https://ec.europa.eu/tools/eudamed, when it is available. A copy of the SSCP is also available at http://www.mainstaymedical.com/resources

Residual Risks and Potential Complications

The implantation of ReActiv8 involves risks similar to those of peripheral nerve stimulators . In addition to risks commonly associated with surgery, implantation or use of ReActiv8 includes, but is not limited to, the following risks:

• Adverse Events (AEs) associated with the surgical procedure, including implant, revision, replacement and removal. 
• Acute or persistent pain including more pain than anticipated after surgery or worsened low back pain. 
• Accidental injury to adjacent tissues, e.g., piercing structures such as muscle, blood vessels or organs. 
• Infection, including local infection of the surgical site, systemic infection and sepsis 
• Slow, abnormal or inadequate wound healing including wound dehiscence (slow healing), which may require surgical repair. 
• Tissue reaction to the presence of the implanted device or materials in/on the implanted device such as response to residual material on device or an allergic response, e.g., previously unknown nickel or titanium allergy. Reaction may be local or systemic. 
• Nerve irritation, impingement or damage, including that resulting from mechanical presence of device, exposure to electricity including electrical stimulation, or migration of the leads, suture sleeve or IPG. This may lead to pain, paralysis, sensory deficits or changes to bowel, bladder or reproductive function. 
• Device extrusion. 
• Erosion, threatened erosion or fistula formation in skin overlying device components. 
• Excessive fibrotic tissue growth. 
• Hematoma, seroma, cyst or swelling. 
• Acute or persistent pain including worsened low back pain and/or pain and discomfort due to presence of the device. 
• Undesired sensations such as uncomfortable paraesthesia, numbness, vibration, pressure, prickling, or uncomfortable contraction of the multifidus. 
• Overstimulation of tissue, resulting in symptoms such as painful muscle contraction, paraesthesia, jolts or shocks. In addition, injuries that occur as a consequence of stimulation, e.g., accidents that occur as a result of being startled. 
• Tissue damage due to mechanical presence of device, or exposure to electricity including electrical stimulation. 
• Contraction of muscles other than the target muscle(s). 
• Muscle fatigue, spasm or injury. 
• Stiffness, including restricted motion due to adhesions to the device. 
• Inability to deliver stimulation, including inadequate doses of stimulation. Causes include lead migration, device malfunction or exposure to electromagnetic fields, e.g., security screening devices. 
• Undesired electrical stimulation. 
• Inability to stop therapy, with possible sequelae such as anxiety, restriction of movement, pain, muscle fatigue, postural changes, difficulty in walking, sitting or physical activity. 
• Accidents, injuries, body movements, body positions or biological process which lead to device complications. Examples include a fall which may cause damage to the IPG; sit-ups or severe coughing leading to migration of the lead; or fracture of bones leading to device migration or damage.
• You may also undergo medical and/or surgical intervention (such as revision or explant) to treat the issues identified above.

Warnings

• It is very important that you inform your physician or other healthcare professional (e.g. physical therapist, chiropractor, dentist, etc.) that you are implanted with the ReActiv8.  

• Magnetic Resonance Imaging (MRI) – MRI compatibility of the ReActiv8 system is conditional on imaging parameters. Refer to the ReActiv8 System Magnetic Resonance Imaging (MRI) Guidelines (discussed below). 
• Diathermy – You SHOULD NOT receive diathermy therapy, as it may be hazardous for you.
• Strangulation by cable – When operating the Activator, keep the antenna cable away from your neck to avoid strangulation. Do not allow children to handle or play with the Activator.
• Case damage – In the case that the Activator is pierced or ruptured, burns could result from exposure to battery chemicals. 

Precautions

Electromagnetic interference (EMI)

Electrical and/or electronic equipment emits energy when it is powered “ON”. This energy is referred to as electromagnetic energy. Electromagnetic energy may be generated by equipment found in the home, work, medical or public environments. In some cases, this energy may cause interference with other electrical or electronic equipment. Disturbance or interference resulting from exposure to energy emitted by other electrical or electronic equipment is referred to as electromagnetic interference (EMI). For example, some televisions may display a disrupted picture when an electrical appliance is operated nearby.

The ReActiv8 includes features that provide protection from EMI. Most electrical devices and magnets encountered in a normal day are unlikely to affect the operation of the ReActiv8. Sources of strong EMI can exist near high power amateur radio transmitters, near television towers, electrical welders, or other equipment. Generally, the amount of EMI present in publicly-accessible areas is at a level that is not likely to impact the ReActiv8. However, prior to entering controlled-access areas near these sources, please contact your physician for guidance.

Equipment such as retail theft prevention systems and airport metal detectors may interfere with the ReActiv8. Walk directly through such systems and do not remain near them any longer than necessary. The ReActiv8 in your body may set off security screening devices (e.g., at airports), so it will be necessary for you to carry your identification card to identify yourself to security screeners as a ReActiv8 user.

Exposure to strong sources of EMI can result in the following effects:

• Serious injury or death, resulting from heating of the implanted components of the ReActiv8 and damage to surrounding tissue.
• Damage to the ReActiv8, resulting in a loss of or change in stimulation delivery and requiring surgical replacement.
• Operational changes to the ReActiv8 IPG, causing it to turn ON or OFF (particularly if the IPG is enabled for magnet use) or to reset, resulting in loss of stimulation and requiring reprogramming by a clinician.

Electromagnetic interference (EMI) from household items 

• Most household appliances and equipment that are working properly and grounded properly will not interfere with ReActiv8. Many household items contain magnets or generate magnetic fields that are strong enough to activate the magnet switch inside the IPG, which can be programmed to start or stop therapy. 
• If interference is suspected, move away or turn off the household item.

Activator and Magnet

• Activator handling – To avoid damaging the Activator, do not immerse it in liquid; do not clean it with nail polish remover, mineral oil, or similar substances; avoid spilling fluids on it; and do not drop it or mishandle it in a way that may damage it.

Magnet use – Depending on how the ReActiv8 IPG is programmed, the magnet may not be able to start or stop a Session. If this is the case, you must have an Activator to start or stop Sessions.

Magnet may damage items – Do not place the ReActiv8 Magnet on or near computer monitors, magnetic storage disks or tapes, televisions, credit cards, or other items affected by strong magnetic fields. If the magnet is too close, these items may malfunction or be damaged.

Target Population 

ReActiv8 is not suitable for every patient with chronic low back pain. When selecting candidates for ReActiv8, the following is considered: 

• Chronic low back pain despite medical management and attempting at least one course of physical therapy. 
• Able to operate the system. 

The safety and effectiveness of the ReActiv8 system has not been established for: 

• Pregnant women (including effects on a foetus, or during childbirth) 
• Paediatric use (patients under the age of 18) 
• Patients with worse leg pain than back pain 
• Patients with radiculopathy below the knee 

Limitations of Use 

• Physical activity – Your clinician will advise you to limit your activities to low or moderate levels during the first few weeks after implantation of the IPG and leads. Failure to do so may result in migration of or damage to the leads, requiring a revision surgery to reposition or replace the leads. Even after healing, activities involving sudden jerking may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. 
• Equipment operation – During a Session you should remain in a relaxed reclined, supine or prone position. While receiving stimulation, you should not operate potentially dangerous equipment, such as power tools, automobiles, or other motor vehicles. You should not climb ladders or participate in other activities where postural change or an abrupt movement could alter the perception of stimulation intensity and cause you to fall or lose control of your equipment or vehicles or injure others.
• Component manipulation – You should avoid manipulating or rubbing the implanted components of ReActiv8 through the skin. Manipulation may cause component damage, lead dislodgement, skin erosion, or unwanted stimulation at the implant site. 
• Scuba diving or hyperbaric chambers – You should not dive below 5 meters (16 feet) of water or enter hyperbaric chambers above 1.48 atmospheres absolute (ATA). Pressures below 5 meters (16 feet) of water (or above 1.48 ATA) could damage the IPG. Before diving or using a hyperbaric chamber, you should discuss the effects of high pressure with your physician. 
• Skydiving, skiing, or hiking in the mountains – The Activator will remain operational at altitudes <3000 meters (approximately 10,000 feet). However, you should consider the movements involved in any planned activity at high altitude and take precaution to avoid putting undue stress on the implanted parts. 
• Operating temperature – Do not use the Activator when the air temperature is greater than 40°C or below 0°C. 

MRI Safety Information

Magnetic Resonance Imaging (MRI) 

The ReActiv8 Implantable Pulse Generator (IPG) and implantable leads are MR Conditional devices with demonstrated safety in the MR environment only within specified conditions. 

Consult with your healthcare provider prior to an MR exam and inform MRI site personnel that you have an MR Conditional medical device during MR screening prior to the MR exam. 

Obtain the latest MRI Guidelines 

Refer to the document ReActiv8 System Magnetic Resonance Imaging (MRI) Guidelines for a list of approved MR Conditional components, model numbers and required conditions (including patient preparation) for safe use in the MR Environment. This document may be updated periodically. The latest version of these guidelines may be obtained at www.sherdev.wpengine.com/resources  or through Mainstay Medical with the contact information provided at the beginning of this document. Referring to this document prior to an MRI scan is mandatory. 

Failure to follow these guidelines for MRI scans may result in severe patient injury and/or device malfunction.

The Mainstay Tunneler (Model TUN1) contains up to 0.26% cobalt, which exceeds the hazardous substance limit of 0.1% w/w. 

Manufacturer’s name and address

Mainstay Medical Limited

Clonmel House,
Forster Way,
Swords, Co. Dublin, K67F2K3
Ireland