Important Safety Information
Sacral Neuromodulation for Bladder Control
InterStim Therapy for Urinary Control treats urinary retention (inability to completely empty the bladder) and the symptoms of overactive bladder, including urinary urge incontinence (leakage) and significant symptoms of urgency-frequency. It should be used after you have tried other treatments such as medications and behavioral therapy and they have not worked, or you could not tolerate them.
You should have a successful trial assessment before receiving InterStim Therapy. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device.
InterStim Therapy is not intended for patients with a urinary blockage. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological diseases such as multiple sclerosis.
In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, lead (thin wire) movement/migration, device problems, interactions with certain other devices or diagnostic equipment such as MRI, undesirable changes in urinary or bowel function, and uncomfortable stimulation (sometimes described as a jolting or shocking feeling).
This therapy is not for everyone. Please consult your physician to decide whether InterStim Therapy is right for you. A prescription is required. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
USA Rx Only. Rev 0110