ReActiv8

Safety & Product Information

USA Rx Only
CAUTION: Federal law (USA) restricts this device to sale, distribution and use by or on the order of a physician. Refer to user manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications for Use: The ReActiv8 System is indicated for bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the L3 transverse process as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing 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 or unsuitable for ReActiv8 implant surgery.

Refer to The ReActiv8 System MRI Guidelines at mainstaymedical.com/resources for complete conditions information.

Magnetic resonance imaging – The ReActiv8 Implantable Pulse Generator (IPG) and implantable leads are MR Conditional devices with demonstrated safety in the MR environment only within specified conditions. Refer to the document ReActiv8 System Magnetic Resonance Imaging (MRI) Guidelines for an up-to-date list of approved MR Conditional components, model numbers and required conditions for safe use in the MR Environment.

Direct the patient to consult with their healthcare provider prior to an MR exam and inform MRI site personnel that they have an MR Conditional medical device during MR screening prior to the MR exam.

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

Diathermy: Safety of diathermy with an implanted ReActiv8 has not been evaluated. Do not use short – wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a ReActiv8.

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.

Electromagnetic interference: Electromagnetic interference from electrical or magnetic fields generated by equipment found in the home, work, medical or public environments may interact with or disrupt the function and operation of ReActiv8.

Defibrillation/cardioversion: When a patient is in ventricular or atrial fibrillation, the first consideration is patient survival. External defibrillation or cardioversion can damage the ReActiv8 IPG. It may also cause induced currents in the leads that can injure the patient.

For additional ReActiv8 safety information, please see the Summary of Safety and Effectiveness Data document.

EU Only

Carefully read all contraindications, warnings, precautions, considerations for patient selection and instructions before use. Follow all operating, maintenance, and installation procedures as described in this manual. Failure to do so may result in patient or operator harm.

Safety may be compromised if the procedures used to operate and maintain the ReActiv8 system are different than those specified in the manuals. Anyone who performs the procedures must be appropriately trained and qualified.

Intended Purpose/Indications for Use: ReActiv8 is an adjunct to medical management of Chronic Low Back Pain for relief of pain in adults who have attempted at least medical management and physical therapy.

Contraindications: ReActiv8 is contraindicated for patients who are unable to operate the system or unsuitable for ReActiv8 implant surgery.

Warnings:

Electromagnetic Interference (EMI): Electromagnetic interference from electrical or magnetic fields generated by equipment found in the home, work, medical or public environments may interact with or disrupt the function and operation of ReActiv8.

Magnetic Resonance Imaging (MRI): Safety of MRI with an implanted ReActiv8 has not been evaluated. Do not use MRI on patients who have been implanted with the ReActiv8 system.

Diathermy therapy: Safety of diathermy with an implanted ReActiv8 has not been evaluated. Do not use short – wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a ReActiv8.

Defibrillation/cardioversion: When a patient is in ventricular or atrial fibrillation, the first consideration is patient survival. External defibrillation or cardioversion can damage the ReActiv8 IPG. It may also cause induced currents in the leads that can injure the patient.

Electrocautery and radio frequency (RF) ablation: Electro-surgery devices should not be used in close proximity to the ReActiv8 IPG or Lead(s). Contact between a lead and the electrosurgical instrument can cause direct stimulation of a nerve and can result in severe injury to the patient.

ReActiv8 interaction with other active implantable devices: Safety of the ReActiv8 system has not been evaluated when used in combination with active implantable devices (e.g. pacemaker, defibrillator, spinal cord stimulation).

Case damage:  If the ReActiv8 IPG case is pierced or ruptured, severe burns could result from exposure to battery chemicals.

Australia Only
Click to view: Therapeutic Goods Administration (TGA)

ALWAYS READ THE INSTRUCTIONS FOR USE. Refer to user manual for a complete listing of indications, warnings, precautions, potential adverse events, and directions for use. If symptom persist, worsen or change unexpectedly, talk to your health professional.

Intended Purpose/Indications for Use: The ReActiv8 System is indicated as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing.

Warnings

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