StimRouter Neuromodulation System

StimRouter is available by prescription only.

 

Indications for Users in the US

Chronic Pain Management: Indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

 

Indications for Users Outside the US

Chronic Pain Management: Indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain of craniofacial nerve origin.

 

Overactive Bladder: Indicated for the treatment of patients with Overactive Bladder (OAB) and the associated symptoms of urinary urgency, urinary frequency and urge incontinence.

Faecal Incontinence: Indicated for the treatment of chronic faecal incontinence in patients who have failed or are not candidates for more conservative treatments.

 

Contraindications

The StimRouter Neuromodulation System is contraindicated for:

  • Patients who have any active implanted device such as an implanted demand cardiac pacemaker or defibrillator, or any metallic implant in the immediate area intended for implant. Maintain a minimum safe separation distance of 15 cm (6 in.) between the StimRouter Electrode with External Pulse Transmitter and all other active implanted devices and metallic implants.

A risk/benefit determination should be performed before using the StimRouter system for:

  • Patients exposed to diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be used on patients who have a StimRouter Neuromodulation System. The energy generated by diathermy can be transferred through the StimRouter system components, causing tissue damage at the lead site and potentially resulting in severe injury. Diathermy may also damage the StimRouter system components, resulting in loss of therapy. Injury or damage can occur during diathermy treatment whether neurostimulation is turned on or off. All patients are advised to inform their health-care professionals that they should not be exposed to diathermy.
  • Patients exposed to therapeutic ultrasound.
  • Patients who are unable to operate the StimRouter system.
  • Patients who are high surgical risks or poor surgical candidates in general.
  • Patients who have a cancerous lesion present near the target stimulation point or near to where the StimRouter Electrode will adhere.
  • Patients with bleeding disorders or active anticoagulation that cannot be stopped for a few days close to the time of the surgical procedure.
  • Do not use the transmit/receive RF head coil if the StimRouter Lead is implanted above the shoulder.

 

Product Warnings

  • An MRI examination performed on a patient with an implanted StimRouter Neuromodulation System Lead should only be done if there is a valid indication as determined by the supervising physician,and then only if all guidelines are carefully followed. Please refer to the MRI Safety Information section in the appropriate User Guide for the most current MRI Safety Information for your world region.

 

Potential Adverse Events

  • The utilization of MRI could result in excessive heating of the StimRouter Lead if all MRI parameters and conditions of use are not carefully followed. Induced voltages in the StimRouter Lead may occur due to the time-varying, gradient magnetic fields of the MR system, possibly causing uncomfortable levels of neurostimulation. Note: Since the StimRouter Lead is not a life-sustaining device, it could be explanted from the patient prior to an MRI exam and re-implanted after the MRI exam.
  • The effects of electrical stimulation on pregnancy are not known. Do not use electrical stimulation during pregnancy.
  • Only your physician should program the StimRouter system.
  • Use only Bioness components with your StimRouter system. Use of non-Bioness components may damage the system and cause injury. No modification of this equipment is allowed. The Patient Programmer and EPT can heat up to 43°C during operation in extremely hot areas/rooms. If this occurs turn off stimulation, remove EPT and Patient Programmer, and set aside until temperature is within operational conditions.
  • The StimRouter is not intended to be used in oxygen-rich environments. Turn off the Patient Programmer and stimulation when you are near a refueling station, flammable fuel, fumes or chemicals. If your system is on, it could ignite the chemicals or fumes, causing severe burns, injury or death.
  • Turn off stimulation while driving or operating machinery.

 

Electromagnetic Compatibility Warnings

  • Operation of the StimRouter system in close proximity (e.g., 1 meter) to shortwave or microwave therapy equipment may produce instability in the EPT output.
  • The following medical therapies or procedures may turn stimulation off. They may also permanently damage the StimRouter external components and may cause injury, particularly if used close to the system components: Lithotripsy, electrocautery, external defibrillation, ultrasonic scanning, and high-output ultrasound.
  • Electromagnetic interference (EMI) from the following medical procedures is unlikely to affect the StimRouter system: computerized axial tomography (CT or CAT) scans, diagnostic ultrasound (e.g., carotid scan, Doppler studies), diagnostic x-rays or fluoroscopy. Note: Turn off stimulation and remove the StimRouter Electrode before undergoing a medical procedure.
  • If you require electrosurgery, tell your physician you have an implanted lead. Electrosurgery devices should not be used close to an implanted StimRouter lead. Contact between an active electrode of the electrosurgery device and the implanted lead can stimulate the lead and cause severe injury.
  • Remove the StimRouter electrode before medical treatment. If you are connected to the StimRouter system and high-frequency surgical equipment, you may experience a skin burn where the gel electrodes adhere. Also, the StimRouter EPT may become damaged.
  • Although unlikely, body-worn medical devices may interfere with the RF communication used in the StimRouter system. Stimulation control may be delayed. Examples of a body worn device are a pain pump or an insulin pump and a monitoring device. The patient programmer will emit visual alerts if interference occurs. To minimize interference, maintain a minimum safe separation distance of 15 cm (6 in.) between the StimRouter system and all other electronic devices. See the “Troubleshooting” section for help. See the “Appendix” for more information. The StimRouter system’s wireless technology may cause EMI to other body-worn medical devices. Refer to the instructions for use for those devices for information on recommended minimum separation distances.
  • Certain types of security devices may affect stimulation. Examples include those used at the entrances and exits of public buildings such as libraries, airports and retail stores. Ask for help to bypass the device. Show your Medical Device Identification Card if you must pass through the device:
    • Turn off your StimRouter system.
    • Pass through the security screening device quickly.
    • Stay as far from the emitter as possible. Walk, for example, in the center of a pass-through security gate.
  • There is potential for interference between electronic devices, including cell phones. Stimulation control may be delayed. If interference is suspected or anticipated, distance yourself from the source of interference. To minimize interference, maintain a minimum safe separation distance of 15 cm (6 in.) between the StimRouter system and all other electronic devices.

 

Precautions

  • After the implant procedure, check the incision site for infection, possible device rejection or other possible adverse effects. Contact your physician immediately if you have: excessive redness or discharge around the incision site, prolonged pain at the incision site., warmth and swelling of the incision site, fever, dizziness, or bleeding.
  • Leads may fail at any time. If a lead fails or breaks, then the lead may need to be removed or replaced. It is possible that small fragments of the lead could remain at the implantation site after removal, which will indefinitely prevent you from being eligible for certain procedures, such as diathermy, therapeutic ultrasound, or MRI in the affected area. Immediately contact your physician, if implant failure is suspected.
  • Changes in posture or abrupt movements may change the stimulation you feel. Turn off stimulation before stretching or exercising.
  • Do not adhere the StimRouter Electrode to any other person or any other part of your body.
  • Keep all StimRouter components out of the reach of children.
  • Do not adhere the StimRouter Electrode to skin that is swollen, infected or inflamed or to skin that is broken. Do not adhere the StimRouter Electrode over veins that are swollen or inflamed.
  • It is normal for the skin under the StimRouter Electrode to become red. The redness should disappear about one hour after you remove the StimRouter Electrode. Some people may be allergic or hypersensitive to the electrical stimulation or the gel on the StimRouter Electrode. Persistent redness, lesions or blisters are signs of irritation. Stop using the StimRouter system until the irritation is gone. To avoid irritation, remove the StimRouter Electrode every three to four hours for 15 minutes. Talk to your physician if irritation persists.
  • As with other nerve stimulation devices, the StimRouter achieves pain relief by causing different sensations to be felt in the area of treatment. These sensations (also referred to as “paresthesia”) include tingling and numbness. While these sensations are normal during StimRouter use, stimulation should not proceed to the point of being painful.
  • Do not use a StimRouter Electrode with a “Use by” date that has expired.
  • Precautions related to theStimRouter Electrode Placement and Stimulation
    • Use only StimRouter Electrodes manufactured by Bioness Inc.
    • Only your physician should decide where to place the StimRouter Electrode.
    • Only your physician should program your StimRouter system.
    • Turn off stimulation before adhering, removing or handling the StimRouter Electrode.
    • Do not adhere the StimRouter Electrode across your chest or near your heart. Electrical stimulation of the heart may disturb heart rhythm.
    • Apply user patch only to the areas recommended by your physician. Avoid placing the user patch across or through the head, directly on the eyes, covering the mouth, on the front of the neck, (especially the carotid sinus).
    • Do not adhere the StimRouter Electrode over anything other than skin. Do not adhere it over an adhesive bandage, for example. The StimRouter Electrode must be in full contact with the skin or the stimulation could cause serious injury.
    • Do not place the StimRouter Electrode over skin folds, scarred tissue, irritated skin, uneven skin surfaces or broken skin.
    • Always check the StimRouter Electrode gel pads before use. Do not use the StimRouter Electrode if the gel appears dry, worn, dirty or irregular.
    • Remove the clear protective cover from the StimRouter Electrode before using.
    • Do not handle the StimRouter Electrode with both hands while stimulation is on. Serious injury can occur if electrical current passes through your heart.
    • Do not apply the StimRouter Electrode to anyone else or any other part of the body than that determined by your physician.
  • Handle all StimRouter components with care. Dropping components on hard surfaces, or other rough handling, can damage them. Avoid exposing them to extreme temperatures or moisture. Protect all StimRouter components from contact with water, such as from sinks, bathtubs, shower stalls, rain and snow.
    • StimRouter Electrode Storage Temperature Range: 5°C to 27°C (41.0°F to 80.6°F)
    • External Pulse Transmitter (EPT) Storage Temperature Range: -20°C to +60°C (-4°F to +140°F)
    • Patient Programmer Storage Temperature Range: -20°C to +60°C (-4°F to +140°F)

 

Adverse Effects

  • If the lead is not placed properly, it may need to be removed or your therapy may need to be adjusted. Nerve injury is possible, although unlikely. Possible surgical complications include infection and device rejection. Contact your physician immediately if you experience fever, swelling, bleeding or prolonged pain at the implant site.
  • Stimulation of skin and muscles surrounding the lead may cause increased pain. You may have undesirable movements during stimulation. If this occurs please contact your physician.
  • Additional risks related to the StimRouter System.
    • If the lead moves, it may change the stimulation effectiveness.
    • While very unlikely, the tissue around the lead may react to the implanted materials.
    • External electromagnetic interference (EMI) may cause the StimRouter components to malfunction. EMI may also affect stimulation.
    • You may have persistent pain at the implant site.
    • Although rare, the skin overlying the lead may erode.
    • Portable and mobile radio frequency communications equipment can affect medical electrical equipment.
    • The StimRouter external components could overheat if the components fail. Overheating could cause burning.
  • If you experience any discomfort during stimulation, or notice any skin abnormalities: Stop stimulation immediately, stop contact with the StimRouter components, notify your physician.