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• Device fracture/failure
• Device migration
• Electrical shock
• Infection
• Pain or irritation at Stimulator and/or lead site
• Seroma, hemorrhage, and/or hematoma
• Suspected lead migration
• Suspected nerve injury (including numbness)
• Suspected technical device malfunction
• Transient electric shock or tingling
• Unintended nerve activation
• Heating or burn at Stimulator site
• Lack of effectiveness
• Reoperation/Revision
• Undesirable change in pelvic function
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
• The patient does not have a history of sensitivity to stimulation
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