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Important Safety Information

Urinary Retention

Sacral Neuromodulation for Bladder Control (Medtronic Bladder Control Therapy Delivered by the InterStim System)

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 behavioural therapy and they have not worked, or you could not tolerate them.

You should have a successful trial assessment before receiving InterStim™ Therapy.  If you don’t have an appropriate response to test stimulation or are unable to operate the neurostimulator then Interstim™ Therapy may not be the best treatment option for you. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim™ device and this should be discussed with your health care professional

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. Your health care professional should discuss if Interstim™ therapy is an appropriate choice for you.

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 doctor to decide whether InterStim™ Therapy is right for you.  For further information, please call Medtronic Technical Support Helpline on 01923 205101 and/or consult Medtronic’s website at www.medtronic.com

 

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Your information will be processed and protected in accordance with our privacy statement

 

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