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Important Safety Information

Bowel Incontinence

Sacral Neuromodulation for Bowel Control

Medtronic Bowel Control Therapy (Sacral Neuromodulation delivered through the InterStim™ System) treats chronic faecal 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 should have a successful evaluation before receiving Medtronic Bowel Control Therapy. 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).

Consult your doctor to decide whether Medtronic Bowel Control Therapy is right for you. For further information, please call the Medtronic Technical Support Helpline on 01923 205101.

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