Important Safety Information
IMPORTANT SAFETY INFORMATION:
Indications:Axonics SNM Therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence (leakage) and significant symptoms of urgency-frequency, either alone or in combination, in patients who have failed or could not tolerate more conservative treatments. Axonics SNM Therapy for bowel control is indicated for the treatment of chronic faecal incontinence. The therapy should only be used in patients who have failed or are not candidates for more conservative treatments.
Contraindications: The Axonics SNM System is contraindicated for patients who have not demonstrated an appropriate response to test stimulation or patients who are unable to operate the Axonics SNM System.
This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.
Implantation and use of the Axonics System incurs risk beyond those normally associated with surgery, some of which may necessitate surgical intervention. These risks include but are not limited to adverse change in voiding function (bowel and/or bladder), infection, pain or irritation at the implant site, lead or device migration, electrical shock, change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or shocking) by some patients, and heating or burns at the device site.
Results and experiences may vary and are unique to each patient. No promise or guarantee is made about specific results or experiences. Talk to your doctor about whether the Axonics System is right for you and to discuss the potential risks and benefits.
For more information about safety and potential risks, refer to Information for Prescribers and Patients at www.axonics.com/eIFU.
The safety and effectiveness of the Axonics System has not been established for use in women who are pregnant or in delivery; for pediatric patients (under the age of 18 years for faecal incontinence and under the age of 16 years for overactive bladder and urinary retention); for patients with neurological disease origins, such as multiple sclerosis or diabetes; or for bilateral stimulation.
Caution: This device can be sold and used by, or on the order of, a physician only. For Summary of Safety and Clinical Performance (SSCP), refer to https://ec.europa.eu/tools/eudamed/#/screen/home.Adverse Event Reporting
In case of any serious incident related to the product, please report to Axonics (+1-877-929-6642) as well as the competent authority of your state, which can be found here: https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human.