ReActiv8 Safety 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.

Warnings: ReActiv8 therapy has not been evaluated in patients with evidence on an MRI scan of a pathology that may be amenable to surgery (e.g., severe stenosis, moderate to severe scoliosis). 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): 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: 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.