INDICATIONS, SAFETY, AND WARNINGS Percutaneous Tibial Neuromodulation (PTNM)

Indications, Safety, and Warnings for Medtronic NURO System

Indication for Use: Medtronic NURO™ Percutaneous Tibial Neuromodulation is intended to treat patients with overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

Contraindications: Do not use on 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.

Warnings/Precautions/Adverse Events: 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. For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic's website at Product technical manual must be reviewed prior to use for detailed disclosure.

USA Rx only. Rev 0915