IMPORTANT SAFETY INFORMATION MEDTRONIC BLADDER CONTROL THERAPY

Medtronic Bladder Control Therapy delivered by the InterStim system

Medtronic Bladder Control Therapy delivered by the NURO system

Medtronic Bladder Control Therapy delivered by the InterStim™ system 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 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.

This 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 disease origins.

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). 

Medtronic Bladder Control Therapy delivered by the NURO™ system treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. This therapy is not intended for patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function, or on patients who are pregnant or planning pregnancy. Do not use if the skin in the area of use is compromised. Exercise caution for patients with heart problems. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site.

These therapies are not for everyone. These treatments are prescribed by your doctor. Please talk to your doctor to decide whether these therapies are right for you. Your doctor should discuss all potential benefits and risks with you. Although many patients may benefit from the use of these treatments, 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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