Component handling – Handle the components of the Axonics SNM System with extreme care. They may be
damaged by excessive force or sharp instruments. Such damage can lead to intermittent stimulation or loss of
stimulation altogether and may require surgery to replace.
INDIVIDUALIZATION OF TREATMENT
Fully inform the patient about the risks and benefits of SNM therapy. This includes risks of the surgical procedure,
follow-up responsibilities, and self-care requirements. In order to achieve optimal benefits from the therapy, the
Axonics SNM System requires a long-term commitment to post-surgical management.
Patient selection – Select the patients carefully to ensure they meet the following criteria:
• The patient is an appropriate surgical candidate. Give special consideration for the lead length, implant depth,
and ability to successfully implant the lead and route the lead to the Neurostimulator.
• The patient can properly operate the Axonics SNM System. This includes the ability to use the Remote Control, to
detect alignment of the Charger, and to understand when charging is complete.
• If the patient underwent a test stimulation period, he/she received satisfactory results.
• The patient does not have a history of sensitivity to stimulation.
ADVERSE EVENTS
Implantation and use of the Axonics SNM System incurs risk beyond those normally associated with surgery. Some risks
may necessitate surgical intervention. These risks include, but are not limited to the following:
• Adverse change in voiding function (bowel and/or bladder).
• Allergic or immune system response to the implanted materials that could result in device rejections.
• Change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or
shocking) by some patients.
• Infection.
• Pain or irritation at Neurostimulator and/or lead site.
• Seroma, hemorrhage, and/or hematoma.
• Suspected lead or Neurostimulator migration or erosion.
• Suspected nerve injury (including numbness).
• Suspected technical device malfunctions.
• Transient electric shock or tingling.
• Unintended nerve activation.
• Heating or burn at Neurostimulator site.
PATIENT COUNSELING INFORMATION
Clinicians should provide the following:
• Information about the components of the Axonics SNM System.
• Instructions for using the Remote Control.
Also, the clinician should provide each patient with a copy of the Axonics SNM Trial System Guide. The clinician
should review the following sections with him/her:
• Getting the Trial System.
• The Test Period
Clinicians should also instruct their patients as follows:
• Patients should tell their healthcare professionals, including their primary doctor and dentist, that they have
a trial neuromodulation system. Patients should bring their Trial System Guide to all medical and dental
appointments. This will help resolve any questions that their healthcare professional may have regarding any
precautions to take to avoid potential device problems.
• Patients should always carry their Remote Control. This allows them to change the stimulation amplitude and/
or turn the TS on or off.
• Patients should always bring their Remote Control to appointments related to their Axonics SNM System,
including all programming sessions.
• Patients should contact their physician if they have any unusual signs or symptoms.
COMPONENT DISPOSAL
The following steps should be taken when the Axonics SNM System is explanted (for example, due to replacement,
cessation of therapy, or after patient death) or when disposing of accessories:
• If possible, the explanted component should be returned to Axonics along with completed paperwork for
analysis and disposal.
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