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Telemetry signal disruption from EMI
–The Neurostimulator should not be programmed near equipment that may generate electromagnetic interference (EMI) as the equipment
may interfere with the CP or Remote Control’s ability to communicate with the Neurostimulator. If EMI is suspected to be interrupting programming, the CP or Remote Control and the
Neurostimulator should be moved away from the likely source of EMI.
Patient activities
Activities requiring excessive twisting or stretching
– Patient activities that may strain the implanted components of the Axonics SNM Systems should be avoided. For example,
movements that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching may cause migration or breakage of the Axonics SNM leads. Lead breakage or
migration may cause loss of stimulation, intermittent stimulation, or stimulation at the fracture site. Additional surgery may be required to replace or reposition the component.
Activities that typically involve these movements include gymnastics, mountain biking, and other vigorous sports. Clinicians should ask their patients about the activities in which they
participate and inform them of the need for restricted activities.
Charging use
– If swelling or redness occurs near the Charger attachment site, the patient should contact their clinician before using the Charger again. Swelling or redness may
indicate an infection or an allergic reaction to the Charger adhesive.
Component manipulation by patient (Twiddler’s syndrome)
– Clinicians should advise patients to refrain from manipulating the Axonics SNM System through the skin.
Manipulation may cause device damage, lead migration, skin erosion, or uncomfortable stimulation.
Scuba diving or hyperbaric chambers
– Pressures below 10 meters (33 feet) of water (or above 200 kPa) could damage the Axonics SNM System. Diving below 10 meters (33 feet) of
water or entering hyperbaric chambers above 200 kPa should be avoided. Patients should discuss the effects of high pressure with their physician before diving or using a hyperbaric chamber.
Skydiving, skiing, or hiking in the mountains
– High altitudes should not affect the Neurostimulator. Nevertheless, patients should be cautious with high altitude activities due
to the potential for movements that may put stress on the implanted components. For example, the sudden jerk that occurs when a parachute opens while skydiving may cause lead
breakage or migration, which may require surgery to replace or remove the lead.
Unexpected changes in stimulation
– A perceived increase in stimulation may be caused by electromagnetic interference, postural changes, and other activities. Some patients
may find this uncomfortable (a jolting or shocking feeling). Before engaging in activities that receiving a jolt would be unsafe for the patient or those around them, patients should
lower the stimulation amplitude to the lowest setting and turn off the Neurostimulator. Patients should also discuss these activities with their clinician.
Patient programming and Remote Control
Patient access to Remote Control
– Patients should carry their Remote Control with them at all times to allow them to adjust the stimulation amplitude and/or turn on/off the
Neurostimulator.
Remote Control may affect other implanted devices
– Patients should avoid placing the Remote Control over or near other active implanted medical devices (for example
pacemaker, defibrillator and other neurostimulators).
Remote Control handling
– To avoid damaging the Remote Control, patients should avoid immersing it in liquid and should clean it with damp soft cloth. Patients should avoid
dropping the device or mishandling it in any way that may damage it.
Remote Control use
– Patients should avoid operating the Remote Control when near flammable or explosive gases.
Storage and Usage Environment
Component packaging – Any component that has been compromised in any way should not be implanted. Do not implant the component if any of the following have occurred:
• The storage package or sterile pack has been damaged, pierced, or altered, as sterility cannot be guaranteed, which may lead to infection.
• The component itself shows any signs of damage. The component may not function properly.
• The use-by date has expired. In this case, component sterility cannot be guaranteed and infection may occur.
Usage environment:
The following lists the appropriate temperature, humidity, and pressure usage conditions for use of the Neurostimulator:
• Temperature: 20°C to 45°C
• Pressure:The Neurostimulator should function at up to 10 m (33 ft) underwater (200 kPa) and at altitudes up to 3000 m (10,000 ft) associated with activities like hiking and skydiving
(as low as 70 kPa)
Shipping and Storage environment:
The following lists the appropriate temperature, humidity, and pressure conditions for shipping and storing the Neurostimulator:
• Temperature (short term: 3 days): -10˚C to 55˚C
• Temperature (long term): 20˚C to 30˚C
• Humidity (short term: 3 days): 15% to 95%
• Humidity (long term): 30% to 85%
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