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

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


MRI Guidelines for InterStim Therapy Neurostimulation Systems


MR Scanning Conditions

MR Conditional: Non-clinical testing has demonstrated that InterStim Therapy
systems have been found to be MR Conditional. If this patient is implanted with an InterStim II Model 3058 Neurostimulator or an eligible serial number of an InterStim Model 3023 Neurostimulator (when implanted as a system including a neurostimulator, lead, and
extension as applicable), MRI examinations of the head only may be safely performed
under the following conditions:

- 1.5-Tesla (T) horizontal closed bore
- Maximum spatial gradient of 19 T/m (1900 gauss/cm)
- RF transmit/receive head coil only (no RF transmit body coil)
- Gradient slew rate limited to 200 T/m/s
- Normal operating mode (Scanning frequency of approximately 64 MHz only)
- If possible, do not sedate the patient
- Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator
off
- Eligible Model 3023 Neurostimulators only: Disable the magnet switch


Scanning under different conditions may result in severe patient injury or device
malfunction.

ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. THE LATEST INFORMATION MAY BE OBTAINED FROM www.medtronic.com/mri

MRI and InterStim Therapy
It is important to read this information in its entirety before conducting a magnetic resonance imaging (MRI) head scan on a patient with any implanted component of a Medtronic InterStim Therapy neurostimulation system. These instructions do not apply to other implantable products, or other devices, products, or items. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions.

MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions.

Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only)
Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans:
? Less than NBV132955H
? Between NBV133037H and NBV133063H
? Between NBV628045S and NBV628263S

MR 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 MR procedure.

REFERENCE

www.medtronic.com/mri

  Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com.
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