Medtronic
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel: 763-505-5000
medtronic.com
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trademarks of their respective owners. UC202002282b EN
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. 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.
Medtronic Bowel Control Therapy delivered by 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.
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.
Medtronic Bladder Control Therapy and Medtronic Bowel Control Therapy:
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.
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.
USA Rx Only. Rev 0517