Indications, Safety, and Warnings
Indications for Use: Sacral Neuromodulation delivered by the InterStim™ system for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
The following Warning applies only to Sacral Neuromodulation for Urinary Control:
Warning :This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.
Sacral Neuromodulation delivered by the InterStim™ system for Bowel Control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.
Contraindications for Urinary Control and for Bowel Control: Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.
Warnings/Precautions/Adverse Events: For Urinary Control : Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 16; or for patients with neurological disease origins.
For Bowel Control : Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 18; or for patients with progressive, systemic neurological diseases.
For Urinary Control and for Bowel Control : The system may be affected by or adversely affect cardiac devices, electrocautery, defibrillators, ultrasonic equipment, radiation therapy, MRI, theft detectors/ screening devices. Adverse events include pain at the implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations, including jolting or shock sensations. Patients should be assessed preoperatively for the risk of increased bleeding. For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com . Product technical manual must be reviewed prior to use for detailed disclosure.
USA Rx Only. Rev 0517
Tibial Neuromodulation delivered by the Altaviva™ system is indicated for treatment of urge urinary incontinence (UUI) in patients who failed or could not tolerate more conservative treatments.
Contraindications: Poor surgical candidates including patients with skin lesions or compromised skin integrity; current or recent history of venous insufficiency and/or venous stasis ulcers in the lower leg; anatomical defects or previous surgeries at the implant site which preclude use of the device. Patients who are not able to operate or receive assistance in operating the system.
Warnings: This therapy is not intended for patients who are considered poor candidates for surgery or are at risk for poor wound healing including, but not limited to, severe uncontrolled diabetes, clinically significant edema in the lower leg, clinically significant peripheral neuropathy, nerve damage, or a neurological condition affecting the lower leg. Do not implant the neurostimulator within 5 cm of another metal implant. This therapy is also not intended for patients with current or unresolved mechanical obstruction such as caused by benign prostatic hypertrophy, cancer, or urethral strictures, or patients with known allergies to any of the materials in the Altaviva™ neurostimulator. Continuous stimulation should not be used as safety and effectiveness have not been established. Safety and effectiveness have also not been established for pregnant women; patients under the age of 18; patients with progressive, systemic neurologic disease; patients with history of urinary retention; bilateral leg stimulation. Diathermy (shortwave and microwave) should not be used on patients with a neurostimulator, as it can cause tissue damage or device damage. The Altaviva™ system may affect the operation of other implanted or external systems. The Altaviva™ system may interfere with the operation of other implanted cardiac devices such as pacemakers and defibrillators. Recharging the neurostimulator within 5 cm of a metal implant may cause recharge heating leading to tissue damage. Do not use the recharger or ankle band in direct contact with an unhealed wound.
MRI Warnings: Prior to an MRI scan, determine if the patient has multiple active or abandoned medical device implants. The most restrictive MRI exposure requirement must be used. MRI scans with another metal implant less than 3 cm away from the Altaviva™ neurostimulator have not been tested, and scanning may cause excessive tissue heating surrounding the device resulting in tissue damage and possible need for surgical intervention.
Adverse Events: In addition to the risks normally associated with surgery, adverse events may include pain at the implant site, infection, reaction to local anesthesia, wound complications, lower leg pain, nerve injury, movement of the implant, adverse change in bowel or urinary function, uncomfortable or unintended stimulation sensations or an inappropriate shock sensation, loss of therapeutic effect, discomfort during recharge, or technical or device problems.
For full prescribing information, refer to the product manuals at www.medtronic.com. Product manuals must be reviewed prior to use for detailed disclosure.
USA Rx Only. Rev 0925
