Reliability in deep brain stimulation

Neurostimulation has been used successfully for disabling tremor disorders and Parkinson's disease. Electrodes are implanted into the deep brain structures with leads extending down to the chest and connecting to the programming hardware and battery source (implantable pulse generator). The only currently U.S. Food and Drug Administration (FDA)-approved treatment of this type is the Activa Therapy from Medtronic, Inc., now in the US market since 1997 and available worldwide. Reliability issues pertaining to the design, manufacturing, and clinical use of this device, with attention paid primarily to those issues unique to implantation and use in humans, will be reviewed.