Medtronic Enterra II Neurostimulator

Medtronic Enterra II Neurostimulator

Humanitarian Device: Authorized by Federal (U.S.A.) Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Description The Medtronic Enterra II Model 37800 Neurostimulator is a programmable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system.

These components comprise the implantable portion of the Medtronic Enterra II system.

The operation of the neurostimulator is supported by a clinician programmer. The neurostimulator (Figure 1) operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation, through the implanted lead system.

A wide range of noninvasively programmable parameters and stimulation modes are available. The neurostimulator provides current parameter information, via telemetry, when used with the clinician programmer.

System Components

• Neurostimulator: Medtronic Enterra II Model 37800
• Controlling Devices: Medtronic Model 8840 Clinician Programmer with Model 8870 Application Card. Model 8527 Printer optional.
• Lead: Medtronic Enterra Model 4351 Unipolar Lead

Inclusion Criteria:

• chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.

Exclusion Criteria:

• Organ transplant
• Organic obstruction
• Pseudo-obstruction
• Prior gastric surgery
• Scleroderma
• Amyloidosis
• History of seizures
• Peritoneal or unstable dialysis
• Chemical dependency
• Pregnancy
• Primary eating or swallowing disorders
• Psychogenic vomiting
• Implanted electronic medical devices
• Age < 18 or > 70 years