Enterra Neurostimulator

The device that appears in this graphic is a representation of a Medtronic device. The graphic does not include certain identifying information that may appear on Medtronic devices, such as model number or serial number.

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The Enterra® neurostimulator received humanitarian device exemption (HDE) approval from the US Food and Drug Administration (FDA) in 2000. Because of the HDE status, the system must be implanted in a medical center whose institutional review board has approved use of the device.

After the neurostimulator is surgically implanted, the doctor uses a handheld, external programmer to adjust the neurostimulator and customize therapy for each patient. Adjustment of stimulation is done without surgery. The therapy can be turned off by the doctor at any time.

Humanitarian Device: The effectiveness of this device for this use has not been demonstrated.

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 25 Jun 2009

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