IMPORTANT SAFETY INFORMATION MEDTRONIC BOWEL CONTROL THERAPY

SACRAL NEUROMODULATION FOR BOWEL CONTROL

Medtronic Bowel Control Therapy delivered by the InterStim™ system treats chronic fecal incontinence (an accident or leaking involving stool).  It should be used after you have tried other treatments such as medications and dietary modifications and they have not worked, or if you are not a candidate for them.

You must demonstrate an appropriate response to the evaluation to be a candidate. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim™ device.

Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 18; or for patients with progressive, systemic neurological diseases. 

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. This treatment is prescribed by your doctor. Please talk to your doctor to decide whether this therapy is right for you. Your doctor should discuss all potential benefits and risks with you. Although many patients may benefit from the use of this treatment, results may vary. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.

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