Axonics 1101, Manual

Page: 9 / 96

9
• Pressure (short term): 57 kPa to 106 kPa
• Pressure (long term): 70 kPa to 106 kPa
If the Neurostimulator was stored at temperatures outside of this range, it should not be used until it has returned to the operating temperature range.
Sterilization
The contents of this package have been sterilized using ethylene oxide. This device is for single use only and should not be resterilized.
System implant
Compatibility – For proper therapy, use only Axonics SNM components. The use of non-Axonics components with the Axonics SNM System may result in damage to Axonics
components, loss of stimulation, or patient injury.
Use of non-Axonics components voids Axonics warranty coverage.
Component failures – The components of the Axonics SNM System may fail at any time. Such failures, such as electrical shorts, open circuits, and insulation breaches are
unpredictable. Also, the Neurostimulator battery will eventually fail to recharge. The rechargeable Neurostimulator battery should provide at least 15 years of service and with
repeated charging the battery will lose its ability to recharge to its full capacity. This may result in the Neurostimulator requiring more frequent recharging. When stimulator can no
longer be maintained with regular charging, the Neurostimulator may need to be replaced.
Component handling –The components of the Axonics SNM System must be handled with extreme care. They may be damaged by excessive force or sharp instruments, which can
lead to intermittent stimulation or loss of stimulation altogether and may require surgery to replace.
INDIVIDUALIZATION OF TREATMENT
The patient should be fully informed about the risks and benefits of SNM therapy, including 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 – Patients should be carefully selected to ensure they meet the following criteria:
• The patient is an appropriate surgical candidate with 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, including 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 of which 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 malfunction
• 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 and Charging System.
Also, the clinician should provide each patient with a copy of the Axonics SNM System Patient Therapy Guide and, in particular, review the following sections with him/her:
• Getting the Axonics SNM System
• Living with the Axonics SNM System
Axonics 110-0003 rev M_output.indd 9 9/25/18 7:49 AM