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.
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 RX Only
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 symptoms persist, worsen or change unexpectedly, talk to your health professional.
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) – You SHOULD NOT have an MRI scan, as it may be hazardous for you.
- 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 – If the case that the Activator is pierced or ruptured, burns could result from exposure to battery chemicals.
Adverse Event Summary
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.
- 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 processes 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.
- 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.
You may also undergo medical and/or surgical intervention (such as revision or explant) to treat the issues identified above.