| Developers: | Medtronic (Medtronik) |
Content |
Activa — the neurostimulator developed by Medtronic improving, according to the company, motility of patients and leveling serious consequences of Parkinson's disease. The device is capable not only to stimulate brain activity, but also to measure bioelectric signals in certain departments of a brain, to write these data and to provide them to the attending physician. Using these data, the doctor can recustomize the program of a neurostimulator and make it more effective.
2018: Shutdown of a neurostimulator lightning stroke
On May 7, 2018 it became known of the case of shutdown of a brain implant of production of Medtronic company after lightning stroke which occurred in the city of Ljubljana, the capital of Slovenia. The 66-year-old Slovene who was at home when the thunderstorm began was the victim. As reported, the lightning stroke which struck the house not only burned its TV and the conditioner, but also disconnected Activa RC neurostimulator.
The woman suffers from involuntary spasms of a neck. To save from them and to return normal life, to it carried out the surgical procedure — deep stimulation of a brain. It means installation of a neurostimulator which sends electric impulses to the electrodes implanted into a brain. The device was placed with the victim under skin near a clavicle.
On the available data, the woman at first did not even notice shutdown of the device. Only in an hour she suspected wrong when cervical spasms suddenly returned. At the same time she could reactivate an implant independently.
The doctor who then examined the pensioner did not reveal damages to the device. As noted, it was promoted by the fact that developers provided a security system of the patient: when current in the device raises to a certain level, the device is switched-off that makes impossible injury of a brain of the patient. The hardware-software module of an implant also did not suffer.
Nevertheless, everything could end far worse if the woman during a thunderstorm decided to recharge a neurostimulator though it also does not need regular feed, the doctor noticed.[1]
In the instruction to the device it is specified that its carriers should belong with care to a possibility of manifestation of the external factors capable to change the normal mode of functioning of a device. For example, tomographs can be dangerous as generate a powerful electromagnetic field.
After inspection of the patient the doctor published results of studying of an implant after impact of a lightning in the authoritative edition Journal of Neurosurgery. At the end the physician provided recommendations for patients with devices of this kind, as at the patient. In particular, he considers dangerous to them stay in a zone where thunderstorm emergence is possible.[2]
2016: Problems in work
At the beginning of July, 2016 the Medtronic company 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.[3]
According to the statement Medtronic, the company received 16 messages about the overestimated indicators of measurement of electrical resistance of the tissues of the person caused by Active wire breakage. In 14 cases these the device had to be taken from bodies of patients, and in two others — the defect was opened during implantation process.
Though it is a problem it is recorded only in a small amount of neurostimulators of Medtronic (from 2009 to 2016 about 20 thousand Activa devices were implanted worldwide), the producer reminded surgeons of need to thoroughly check this equipment regarding the overwound or strongly bent wires.
Also faced a similar problem of Medtronic in April, 2015. Then the company announced risk of wire breakage in the DBS Extensions devices for DBS therapy (Deep Brain Stimulation, deep stimulation of a brain) and asked doctors to read attentively the instruction to avoid failure in operation of the equipment. On the construction DBS Extensions and Activa devices are very similar, from here and identical problems.
Notes
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