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.


ReActiv8 is contraindicated for patients who are: 

Unsuitable for ReActiv8 implant surgery, for reasons such as: 

Possible benefits of ReActiv8

The possible benefits associated with ReActiv8 include: 

*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, when it is available. A copy of the SSCP is also available at

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:



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:

Electromagnetic interference (EMI) from household items 

Activator and Magnet

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: 

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

Limitations of Use 

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  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