Medtronic DBS Extension (brain stimulator)

DBS Extension — the devices developed by Medtronic for deep stimulation of a brain (DBS). The implanted programmable medical devices it is used for treatment of the symptoms connected with motive frustration, epilepsy and Parkinson's disease.

A DBS system consists of the components implanted (the generator, the extender and an electrode on which the electric impulse moves) and not implanted (a programmator of the doctor, the panel of the patient and the charger).

Depending on the course of a disease the doctor can change settings of the device using a programmator, selecting the stimulation parameters which are most suppressing symptoms of a disease and minimizing ghost effects. Thus, the generated impulses change functions of the selected deep structures of a brain and allow to improve quality of life of the patient.

DBS therapy

Main article: DBS therapy (Deep stimulation of a brain)

2019: A brain stimulator exit for treatment of epilepsy with which drugs do not cope

On February 20, 2019 the Medtronic company released the system of deep stimulation of a brain which is intended for treatment of the epilepsy steady against medicines.

According to representatives of the company, at deep stimulation of a brain the structure of DBS Medtronic to a front core of a thalamus delivers controlled electric impulses. The front core is a part of the network involved in spasms, and stimulation from the outside allows to stop undesirable impulses.

Medtronic released a brain stimulator for treatment of refractory epilepsy at which drug treatment powerlessly

The company reported that in May, 2018 treatment using DBS got preliminary approval on use among patients at the age of 18 years and is more senior which do not respond to drug treatment or are steady against three or more antiepileptic medicines. Approval was got on the basis of data in seven years of the research conducted by SANTE company in which use of a system of deep stimulation of a brain at 110 patients at refractory epilepsy with partial attacks was studied.

After approval of regulatory bodies of Medtronic initiated a research among 140 patients for assessment of three-year security and efficiency of a new system. The research will take place in several centers in the USA and Europe.

Commercial availability of stimulators of a brain provides significant option of surgical treatment for patients who have epilepsy and do not respond to medicinal therapy. In researches it was shown that deep stimulation of a brain considerably reduces the frequency and weight of attacks and improves quality of life up to seven years.

In February, 2019 Medtronic announced that a system was already implanted to the first patient in Emory University in Atlanta. Transaction took place successfully, and the patient feels well. Though from the moment of installation of a system there passed only 2 months, the frequency of attacks decreased more than by 50%, and doctors expect further improvement at additional sessions of therapy, the leading researcher of new therapy doctor Robert Gross from Emory University reported.^[1]

2016: Problems in work

In July, 2016 the Management on control of medical products of Australia (TGA) warned about problems in operation of DBS Extension devices with model numbers 7483 and 37086. They appeared more, than the producer said.

During practical use of DBS Extension at patients several deviations were observed, namely:

• injury of an additional spinal nerve;
• severe bleeding or vascular damage;
• careless implantation of devices through edges can result in need of auditing transaction on heart;

At the end of July, 2016 the representative office of Medtronic in Australia and Oceania decided to withdraw DBS Extension for updating in descriptions to products of information on ghost effects which can arise at implementation of this equipment. Having reflected all data on risks, work-related these DBS systems, the producer will help doctors to select more effectively patients who can use these devices.

In brain stimulators of Medtronic ghost effects are detected

At the same time in Medtronic note that the probability of emergence of the new undesirable phenomena when using DBS Extension is very low and makes only 0.008% in a total quantity of procedures of implantation. At the same time the producer strongly recommends doctors to monitor a status of patients which performed operation on DBS Extension implantation carefully.^[2]

In July, 2016 Medtronic sent to medical institutions the letter in which recommended to surgeons to check carefully Activa neurostimulator before its implantations as are recorded a case of a rupture of wires.

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