| Developers: | Medtronic |
| Date of the premiere of the system: | January 2020 |
| Branches: | Pharmaceuticals, medicine, healthcare |
Content |
Main article: Medtronic neurostimulators
2022: Warning about marriage in neurostimulators. Doctors cannot change their settings
On April 26, 2022, it became known that Medtronic issued an urgent notice of safety on the ground regarding its implantable neurostimulator (INS) Percept PC. The letter informs patients that, in rare cases (0.044%), the B35200 model Percept PC INS cannot interact with the physician programmer and/or TM91 Communicator and HH90 Handset systems.
According to the safety notice, in some cases, the INS continues to carry out therapy within the previously specified parameters. Although such cases are rare, Medtronic said it warned users to raise awareness, inform and support its customers.
If the doctor's programmer cannot contact the INS, the inscription "Device search" appears on the programmer screen. If the patient's programmer has been configured previously, he will continue to maintain communication with the INS and will allow the therapy to be corrected and parameters changed within the limits set by the doctor, however, the patient's programmer will not be able to turn off the therapy.
Troubleshooting may delay the surgical procedure for replacing the INS due to the lack of communication with the INS during the implantation procedure. A lack of association with INS after the procedure may mean an inability to adjust therapy, which may lead to improper patient therapy.
From the start of Percept PC sales in January 2020 until the end of February 2022, Medtronic received six confirmed reports of a similar problem. Five reports came from the United States, and one case occurred in Switzerland. Two devices were explanted as a result of the inability to connect to the INS system. Medtronic said it is exploring the possibility of making changes to prevent such cases.[1]
2021: Detection of marriage in neurostimulators
At the end of October 2021, Medtronic issued an urgent notice of safety on the ground in Europe to warn of problems with the implantable Percept PC neurostimulator. The purpose of the notification was to inform customers of a potential malfunction of the B35200 devices after the cardioversion procedure.
Medtronic determined that cardioversion can damage the electronics of the Percept PC device and as a result, the implantable neurostimulator will cease to respond and will not function. This situation can lead to the fact that the device cannot be turned on again, according to a notification from the company. If the therapy is discontinued, this will most likely lead to a return of symptoms of the disease. In some cases, symptoms can return with greater intensity than before implantation, which, in rare cases, can constitute a medical emergency for any patient.
The company received four complaints about the matter from patients who had Percept PC implanted between January 14, 2020 and October 4, 2021. In all reported cases, an explantation procedure was carried out or planned. The search for events or those facts that could affect the appearance of these violations in the device from January 1, 2018 to September 9, 2021 did not reveal any violations in Percept PC that arose with the devices of the model 37601 Activa PC, model 37612 Activa RC or models 37602, as well as 37603 Activa SC.
Medtronic said it was working on updating the information in its guidance to add warning language related to cardioversion. The company as of October 21, 2021 continues to investigate additional measures and potential design changes to reduce the likelihood of damage to implantable neurostimulators.[2]
2020: Announcement
In early January 2020, Medtronic introduced the Percept PC neurostimulator, which the company positions as the only deep brain stimulation system with BrainSense technology. This system not only conducts deep stimulation of the brain, but also recognizes its electrical activity in order to subsequently use this data to correct therapy. The Percept PC neurostimulator is designed for patients with neurological disorders such as Parkinson's disease.
According to Medtronic, BrainSense provides more personalized neurostimulation based on analysis of brain electrical activity. Now medical professionals will be able to use it to treat symptoms associated with Parkinson's disease, essential tremor and primary dystonia, as well as in epilepsy and obsessive-compulsive disorder.
 | Deep brain stimulation has been proven to significantly improve motor function in people with Parkinson's disease compared to standard pharmacotherapy. But when using currently available systems, doctors have to make therapeutic decisions based on clinical assessments and information received from patients, "explained Professor Andrea Kühn, head of the department of motor disorders and neuromodulation at the Charité University Hospital in Berlin. - Percept PC with BrainSense technology should change the situation. Patients and caregivers will be able to obtain objective data on individual brain electrical activity, including data recorded outside the clinic as part of patients' daily lives. With this technology, doctors will be able to more accurately adapt the therapy to the individual needs of the patient based on data on his neural activity. |  |
The Percept PC neurostimulator will enter the Western European market on January 15, 2020.[3]
Notes
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