| Developers: | Medtronic (Medtronik) |
| Branches: | Pharmaceutics, medicine, health care, Medical centers |
Content |
SynchroMed — the implanted infusional system developed by Medtronic company intended for intratekalny introduction of the anesthetizing medicines. The device enters an analgetic directly into a cavity of the vertebral channel that allows to carry out long anesthesia without violation of motor and touch functions. SynchroMed is held for use to patients with chronic pain syndromes, a spastichnost and oncological diseases. By the beginning of November, 2016 the device is implanted more than 238 thousand people.
2020: Medtronic started a cloud platform of data management for SynchroMed II
At the end of January, 2020 Medtronic started a cloud software platform of data management for the system of delivery of the drugs SynchroMed II. The new solution from the American producer was received by the name Efficio. Read more here.
2019
Medtronic withdraws thousands of injuring infusional pumps of SynchroMed II
In December, 2019 Medtronic voluntarily initiated a withdrawal of several thousand implanted infusional pumps of SynchroMed II. The Food and Drug Administration (FDA) recognized the reason of recall the undesirable phenomena of a so-called first class (Class I), i.e. life-threatening the patient.
It turned out that hit of foreign debris can cause a pump stop, interfering with medicine delivery. The company stated that in general defects affected 10,820 pumps with model numbers 8637-20 and 8637-40. The response limited use of SynchroMed II in "extraordinary" cases when further use of the device can be connected with serious injuries and a lethal outcome. As the reasons of these undesirable phenomena serve program and mechanical faults because of which pumps enter medicine with a speed above or below the set regulation.
Earlier Medtronic already solved the problems connected with this pump including undertook measures for the termination of sudden stops of the engine in 2017. Late Medtronic was going to put old products on the market, despite the lack of changes in construction, however there were new problems.
In two cases fault was revealed before implantation of the device. Nevertheless, within five months at least three defective products were set. The alarm signal of a pump warned patients about failures in time, but the threat for health and life remains, especially at development of a syndrome of canceling.
Medtronic believes that nearly 11,000 rejected devices, however the probability of full failure of a pump low are presented at the market. Considering risk of surgical intervention and also that fact that the alarm system of products worked trouble-free, Medtronic does not recommend to change the implanted pumps without fail.[1]
Medtronic withdraws the rejected infusional pumps
At the end of October, 2019 it became known that Medtronic withdraws a part of the implanted infusional pumps of SynchroMed II because of possible fault. The rejected pumps can threaten life of patients.
In the express notice the company explained that it began to receive complaints to a stop of pumps. Investigation of the company revealed presence of foreign particles in the engine which got to the device because of a production problem. The company stated that it defined a source of foreign debris and eliminated it.
According to the message of Medtronic, the stop of the engine stops medicinal infusional therapy and can cause a recurrence of a disease or symptoms of abstinency. For example, at the patients receiving baklofen intratekalno the canceling syndrome which is capable to lead to a zhizneugrozhayushchy status can develop.
The implanted pumps are used mainly for treatment of chronic and oncological pain and also for long-term treatment of a heavy spastichnost. Medtronic reported that as of September 30, 2019 it received five notifications on an early stop of the engine. Two rejected devices were revealed before implantation, the others within five months after transaction. One of these patients needed hospitalization for elimination of symptoms of abstinency.
The company otyzvat models 8637-20 and 8637-40 made during the period from May 4, 2018 to April 5, 2019. Their exact quantity is unknown. The company strongly recommends doctors and suppliers to return to the company all devices of the specified models, however does not insist on preventive replacement of potentially rejected SynchroMed II pumps as complications of transaction can be more serious, than complications from a device engine stop.[2]
Medtronic began a research to prove efficiency of intratekalny introduction of anesthetics
At the end of February, 2019 the Medtronic company announced the beginning of clinical trial of Embrace at which the system effectiveness of intratekalny delivery of the drugs SynchroMed II at the patients with chronic pain who are not receiving opioids orally will be estimated. Researchers suspect that intratekalny introduction of medicine can be more effective, than its combination with oral administration.
Oral opioids are widely used for treatment of chronic pain at patients with incurable diseases, however proofs of efficiency and advantages of such therapy are limited. Doctors and researchers are disturbed by the unrolled epidemic of opioid medicinal dependence therefore the increasing value is purchased by alternatives to oral administration of opioids.
Pump of SynchroMed II of production of Medtronic are implanted under skin and delivers medicine in intratekalny space that allows doctors to appoint lower doses in comparison with oral administration and to adapt delivery of drugs to needs of patients. Besides, Medtronic released recently the Control Workflow system which helps doctors to disaccustom patients to oral opioids.
It is known that the pump of SynchroMed II provides effective anesthesia, allowing to lower a dose of oral opioids or to completely exclude their acceptance. In the research Embrace patients who completely refused oral opioids against the background of intratekalny introduction of medicines will be studied. The available data demonstrate that failure from oral administration of opioids can improve anesthesia that will allow patients to receive intratekalno even a smaller dose of medicine, than at a combination of oral and intratekalny introduction.
Doctors aim to optimize use of long-term alternatives to oral opioids which also SynchroMed II therefore results of the research Embrace can have important clinical value treats.[3]
2018
Start of the system disaccustoming patients to take the opioid drugs through a mouth
On October 16, 2018 Medtronic provided the Control Workflow function for SynchroMed II. The innovation is designed to disaccustom patients to take the opioid drugs orally or at least to lower their dose to pass to the system of intratekalny delivery of drugs which SynchroMed II is.
People with chronic diseases often appear in a situation when for pain relief they have to raise constantly a dose of opioids that reduces quality of life. SynchroMed II delivering medicine directly to a pain source can provide the best anesthesia with smaller amount of ghost effects at the same dose that it was used at ingestion of medicines, the press release says.
Medtronic hopes that the new control system together with the pump bringing an analgetic directly to spinal channel will allow to lower a dose of opiates, and then at all to cancel them. In the retrospective analysis it was shown that 51% of patients with chronic nonmalignant diseases stopped oral administration of opioid means in one year of application of a pump of SynchroMed II.
Control Workflow includes selection criteria of patients which can lower a dose of opiates using SynchroMed II pump and also the recommendation about decrease in a dose and gradual complete canceling of narcotic analgetics which can be personalized for certain patients. A system should help doctors to develop strategies of treatment with the smallest effective dose of medicine for intratekalny introduction.
Thus, Control Workflow allows to select patients to whom application of a pump of SynchroMed II will bring the greatest benefit – for example, of the analgetics receiving very high doses narcotic, patients with intolerance of opiates or patients at whom system therapy by opioid medicines was inefficient.[4]
The death of the child because of a faulty pump
On March 28, 2018 the Court of Appeal of the State of Minnesota resumed legal procedure against Medtronic company according to the complaint of mother of the died patient.
The girl's mother from the State of Florida of Caitlyn Jones filed a lawsuit against Medtronic in 2016, claiming that the implanted medicinal pump of SynchroMed II got littered and did not inject a necessary dose drug which Jones received concerning a spastic kvadriplegiya – a severe form of cerebral palsy. Jones died in 2014 because of the complication connected with violation of a receive mode of medicine, according to the lawsuit.
Originally the Medtronic company rejected charges on the basis of the federal law according to which the exclusive right to estimate security of the most dangerous devices belongs to Federal Service for Surveillance in Healthcare (FDA). It means that laws on consumer protection in 50 states cannot impose additional requirements to medical devices of this class, and it is impossible to appeal to them in cases when claimants do not agree with the decision of FDA.
However the state Court of Appeal did not agree with this solution though fundamental charges that the Medtronic company consciously brought to the market the low-quality device which served as a cause of death of the patient still should be proved. Similar legal procedures are under consideration of court though their quantity is not clear.
Besides, in 2015 it became known that Medtronic repeatedly deviated correction of the violations revealed by inspectors of FDA at the SynchroMed II plant — the complaint to Medtronic and its CEO in which omissions on production control, complaint handling and response were noted arrived. The complaint was settled on the same day, and Medtronic did not recognize the existing omissions offense.[5]
2017
Operation in Russia
In August, 2017 knew of carrying out in Russia difficult operation on implantation of a baklofenovy pump of SynchroMed II for the purpose of effective decrease in involuntary painful reduction of muscles and simplification of a status of the patient.
Transaction took place in Central Research and Development Institute of traumatology and orthopedics (TSITO) of a name of N.N. Priorov. The pump developed by Medtronic company was set to the 8-year-old girl having cerebral palsy.
Unique operation on implantation of a baklofenovy pump was performed by the doctor of higher category, professor Alexander Evgenyevich Yakovlev. The doctor successfully treats more than 20 years pain syndromes, motive frustration, intense violations of brain blood circulation and their effect, executed more than 3000 operations on installation of the systems of delivery of medicines and neurostimulation, reported in TSITO.
When carrying out such transaction drug is injected directly in a back the patient's brain: the reservoir with medicine is entered under skin, and from it on a catheter in a spinal cord deliver medicine on individually picked up dosage. Before transactions the patient takes a baklofenovy test when into a spinal cord it is entered a medicine injection, and if after that the raised tone of muscles decreases, then the test is considered positive.
After transaction at the child involuntary painful reduction of muscles should decrease. It will give normalization of all processes in an organism, including it will have beneficial effect on the speech, the visual and digestive systems, a GIT. The patient begins to be recovered much quicker and more qualitatively.
The press service of TSITO notes that operations on implantation of a baklofenovy pump began to be performed at institute since 2017 on quotas for the Russian citizens.[6]
Response because of program failure
In March, 2017 the Medtronic company announced a withdrawal of the infusional SynchroMed systems because of problems with the software which can lead to incorrect introduction of medicines, threatening life to patients. Information appeared on the website of the Food and Drug Administration (FDA).
Under a response pumps of SynchroMed EL and SynchroMed II which are programmed by doctors for introduction of medicines to certain parts of a body got. Program failure in these devices can lead to delivery of too small or heavy dose of medicine through the catheter implanted under skin. The wrong dosage threatens oppression of respiratory function, a coma or even death, says FDA.
Medtronic released the updated firmware for faulty medicinal pumps and provided additional recommendations for use of the equipment. At the same time devices will not be withdrawn from sale or from patients who already use them.
 | Intratekalny introduction of medicines — an important method of treatment of patients with chronic, pain hard to cure or a heavy spastichnost which unsuccessfully used other options of treatment or faced intolerable ghost effects at oral introduction of drugs. The implanted infusional SynchroMed II system continues to show high general reliability. Medtronic is sure of the capability to provide safe and effective therapy — reported in Medtronic |  |
In 2015 FDA directed Medtronic to stop production and sale of SynchroMed II because of fault. That requirement did not extend to the equipment which was already used by patients.[7]
2016: Fatal cases
On November 1, 2016 it became known of new cases of death of the patients using the implanted infusional SynchroMed II system. The reason consists in overdose of the drugs injected by means of this device.
The British Agency on control of medicines and products of medical appointment (Medicines and Healthcare Products Regulatory Agency, MHRA) published results of the investigation of Medtronic which showed the death of two patients with implanted to SynchroMed II. 103 more devices by July 5, 2016 were recognized defective because of spontaneous excessive injection of anesthetics.
Medtronic reported that final cause and effect relationship between death and overdose is not set, however influence of the last is in a varying degree proved. Violation of the mode of dosing by doctors, incorrect information in clinical records and simultaneous use of other medicines, for example, of the opioid means accepted through a mouth could also become the reason of lethal outcomes.
In 2013 the Food and Drug Administration of the USA demanded a withdrawal of SynchroMed after 14 death of the patients using this device. In 11 cases as it became clear, doctors injected drugs not through a pump, and near it, and two patients died as a result of the shift of a tube of delivery of drugs.[8]
Notes
- ↑ FDA grades new Medtronic SynchroMed II recall as Class I event
- ↑ Medtronic recalls certain Synchromed II pain pumps
- ↑ Medtronic Enrolls First Patient In Clinical Study To Assess Pain Control And Oral Opioid Elimination - Medical Product Outsourcing
- ↑ Medtronic launches workflow system to help wean patients off oral opioids
- ↑ MANCHESTER HOSPITAL SAVES of $166.000 BY BRINGING 3D PRINTING IN-HOUSE WITH MATERIALISE
- ↑ implanted to the child a baklofenovy pump Into scientific research institute of Priorov
- ↑ Medtronic recalls implantable infusion pumps due to software problem
- ↑ Two additional patient deaths linked to Medtronic infusion pump
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