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Medtronic Letter, Neuromodulation Devices, Mr. Steve Manker, Program Director - MR Conditional Systems

January 6, 2011

Medtronic, Inc.
Neuromodulation
7000 Central Avenue NE
Minneapolis, MN 55432
www.medtronic.com
Tel: 763.514.4000


Dear Health Care Professional,

As more neuromodulation devices (neurostimulation and infusion) are developed to address unmet medical needs, one needs to be aware that similar devices may have very different MRI safety conditions, warnings, and/or contraindications. Medtronic believes that the use of MRI is a valuable diagnostic tool and therefore we have worked to understand the potential hazards, redesigned our products and gained regulatory approval to permit patients with specific Medtronic products to undergo MRI procedures. Medtronic has many neurostimulation and infusion systems that have approved labeling for safe MRI scans under certain conditions and continues to invest in expanding MRI access across all neuromodulation therapies. Neuromodulation systems from other manufacturers may contraindicate MRI. Therefore, MRI healthcare professionals should always check the device manufacturer’s labeling.

This is a very active space in the health care industry, new devices are being developed for existing and new therapies, devices are being designed to be conditionally safe for MRI scans, and MRI systems are being improved for faster and higher resolution images. Due to this dynamic environment it is expected that the MRI labeling for these implanted devices will change over time and it is critical to follow the most current labeling for patient safety. The best source for the most current MRI labeling is the device manufacturer (technical support or website). For Medtronic Neuromodulation products, go tohttp://www.medtronic.com/mri/ or call (800) 707?0933.

In addition, please ensure that the patient has the most current device identification information with them to assist in identifying the device manufacturer and the applicable MRI labeling.

Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following:
- All conditions for use for all implanted devices
- The associated risks for a patient with these devices

Failure to comply with the conditions for use can cause serious injury to the patient,
including death or damage to the implanted devices.

Medtronic is dedicated to the highest quality and safest care for neuromodulation patients which includes maintaining and expanding access to the valuable imaging power of MRI.

Best regards,


Steve Manker
Program Director – MRI Conditionally Safe Systems
Medtronic Neuromodulation

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