Product technical manual must be reviewed prior to use for detailed disclosure.
InterStim® Therapy 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.
Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.
Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.
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 such as multiple sclerosis. 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.
For full prescribing information, please call Medtronic at (800) 328-0810.
Product technical manual must be reviewed prior to use for detailed disclosure.
USA Rx only Rev 0409