TH90QFA

Indications, Safety, and WarningsIndications for useSacral 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.WarningThis 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. This product is contraindicated for patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.Warnings/precautions/adverse eventsFor urinary controlSafety 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 controlSafety 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 controlThe system may be affected by or adversely affect cardiac devices, electrocautery, defibrillators, ultrasonic equipment, radiation therapy, MRI, and theft detectors/screening devices. Adverse events include pain at the implant sites, new pain, lead migration, infection, technical or device problems, adverse changes 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 the Medtronic website at medtronic.com. The product technical manual must be reviewed prior to use for detailed disclosure.

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