InterStim Therapy for Urinary Control (Medtronic, Inc. Minneapolis, MN)

NEUROSTIMULATION SYSTEM: INTERSTIM THERAPY SACRAL
NERVE STIMULATION (SNS)
FOR URINARY CONTROL

Neurostimulation System: InterStim Therapy - Sacral

Nerve Stimulation (SNS) for Urinary Control

InterStim Therapy - Sacral Nerve Stimulation (SNS) for Urinary Control (Medtronic, Inc., Minneapolis, MN) is a treatment for urinary urge incontinence, non-obstructive urinary retention, and significant symptoms of urgency-frequency in patients who have failed or could not tolerate more conservative treatments. In properly selected patients, InterStim Therapy can be dramatically successful in reducing or eliminating symptoms.

The implantable InterStim System uses mild electrical stimulation of the sacral nerve that influences the behavior of the bladder, sphincter, and pelvic floor muscles.

This information on MRI pertains to the following Medtronic Neuromodulation products:
- InterStim: Model number 3023
- InterStim II: Model number 3058

Magnetic resonance imaging (MRI) – MRI is not recommended for a patient who has any implanted component of a neurostimulation system. Exposing a patient with an implanted neurostimulation system or component to MRI may potentially injure the patient or damage the neurostimulator.

Clinicians should carefully weigh the decision to use MRI in patients with an implanted neurostimulation system, and note the following:
Induced electrical currents from the MRI to the neurostimulation system or component may cause heating, especially at the lead electrode site, resulting in tissue damage. Induced electrical currents may also stimulate or shock the patient.

Note: This warning applies even if only a lead or extension is implanted.
Factors that increase the risks of heating and patient injury include, but are not limited to, the following:

- High MRI Specific Absorption Rate (SAR) Radio Frequency (RF) power levels.
- MRI RF transmit coil that is near or extends over the implanted lead.
- Implanted leads with small surface area electrodes.
- Short distances between lead electrodes and tissue that is sensitive to heat.
- An MRI may permanently damage the neurostimulator, requiring it be removed or replaced.
- An MRI may affect the normal operation of the neurostimulator. An MRI can also reset the neurostimulator to power-on-reset values requiring reprogramming by a trained InterStim clinician.
- The neurostimulator can move within the implant pocket and align with the MRI field, resulting in discomfort or reopening of a recent implant incision.

In addition, the image details from MRI may be degraded, distorted, or blocked from view by the implanted neurostimulation system.
Patients treated with MRI should be closely monitored and programmed parameters verified upon cessation of MRI.

[MRI healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MRI procedure.]


REFERENCE
http://www.medtronic.com/