Main articles:
Products
- Medtronic Micra
- InSync III
- Medtronic CareLink (pacemaker programmers)
- MyCareLink Heart (pacemaker app)
2021
Medtronic began using software to protect pacemakers from hacker attacks
In mid-April 2021, Medtronic announced a collaboration with the Israeli company Sternum, which began to supply the partner with software to protect pacemakers from hacker attacks. More details here.
Announcement of Medtronic SelectSite C304-HIS - catheter system for pacemaker installation
In the middle of March, 2021 the Medtronic company presented the system of flexible catheters SelectSite C304-HIS for installation of an electrocardiostimulator and also an electrode for cardiostimulation of SelectSecure MRI SureScan Model 3830 which can be used for stimulation of a bunch of Gis now. More details here.
Charger for iPhone 12 turns off Medtronic pacemakers
In mid-January 2021, a new study was published in the Heart Rhythm Journal, according to which a magnetic charger for iPhone 12 is able to deactivate Medtronic's implantable cardioverter defibrillator (ICD).
According to a research, iPhone 12 has a circular set of the magnets developed around the central charging coil that does it compatible to wireless accessories of MagSafe of the company. Under controlled conditions, the researchers brought iPhone 12 to the left of the patient's chest with ICD and noted an immediate cessation of his work.
 | This effect was reproduced several times with a different position of the phone above the pocket, the authors write. |  |
Another study, published January 8, 2021, reported another case of disabling Medtronic ICD due to contact with a mobile device. A woman with an ICD wore an Apple Watch to monitor pulse and activity, and at night, the ICD warned the patient several times about the "activation of the magnetic mode." The authors of this study found that the magnets on the Fitbit and Apple Watch bracelet turned off the ICD at a distance of up to 2.4 cm and 2.0 cm, respectively.
| | With this article, we want to draw the attention of the public to an important health problem relating to the new generation of iPhone 12, which could potentially disrupt the course of the most important therapy necessary to preserve the patient's life, especially when wearing a phone in the upper pockets, the authors of the study write iPhone. - Medical device manufacturers and doctors involved in ICD implantation should remain vigilant and inform their patients about the possible interaction of iPhone 12 and other intelligent wearables with their electronic devices implanted in the heart.[1] | |
2019
Medtronic spoke about marriage in Micra pacemakers
In mid-September 2019, Medtronic reported defective pacemakers that are implanted in Russia and other countries of the world. It turned out that by August the company had received 52 complaints from doctors who had problems installing Micra ICD. Pacemaker defects forced doctors to extend the duration of the implantation procedure or perform additional surgery. More details here.
Indian regulators warn doctors and patients about defective Medtronic pacemakers
In mid-May 2019, the Indian regulatory body warned patients with implantable Medtronic pacemakers about identified problems with the devices. Patients with three models of pacemakers are advised to seek immediate medical attention for dizziness, chest pain and loss of consciousness, as these symptoms may be a sign of sudden discharge of the device's battery.
The Central Drug Standards Oversight Organization (CDSCO) alert was issued shortly after US regulators raised concerns about the use of Astra, Serena and Solara pacemakers manufactured by Medtronic. In their warning of May 7, 2019, they mentioned the case when the Medtronic implantable pacemaker battery completely discharged as a result of a crack in the device's capacitor. This case occurred within the first year from the moment of implantation of the device and ended with the death of the patient. At the same time, the pacemaker did not manage to send a warning to the patient or health care provider, as intended. In another recorded case, the patient showed dizziness throughout the observation period, and the attending physician was unable to establish the pacemaker remotely, so the device was replaced by the patient.
It turned out that a crack in the pacemaker capacitor can lead to a short circuit that can discharge the battery much earlier than expected. Indian regulators warned patients and their treating physicians, asking for attention to the sudden decrease in battery levels during subsequent visits and remote consultations. The battery level should decrease proportionally to the life of the device from the time of implantation and remain within the normal range.[2]
Defective Medtronic pacemakers quickly discharge and threaten patients' lives
In early May 2019, Medtronic warned users of the problem of rapid battery discharge identified in some pacemakers, which could lead to the device being turned off and the patient dying. The defect was found in three devices returned to the manufacturer.
Defective batteries are used in two types of devices - conventional implantable and biventricular pacemakers. The warning concerns pacemakers Medtronic Azure, Astra, Percepta, Serena and Solara. A complete list of model numbers with potential defects is available on the Medtronic device monitoring page. Usually, the validity of pacemakers is 6-15 years, depending on the model and settings. All three confirmed device failures occurred within the first nine months of implantation.
It is believed that the cause in all three cases was the failure of a component called a capacitor. It can cause a short circuit and discharge the battery for several days. Despite the low frequency of detection of the defect (0.0028%), if dizziness, chest pain or severe shortness of breath occurs, patients with potentially defective devices should immediately seek medical attention. These symptoms may indicate sudden pacemaker discharge.
Medtronic said it will continue to use another condenser and add an additional verification stage to the production process. Regulators did not consider it necessary to recall the devices from the market and do not recommend removing implanted pacemakers. However, patients are advised to monitor the pacemaker battery charge with a home MyCareLink monitoring system that sends warnings to doctors and can be monitored through an appropriate smartphone app.[3]
Recall of 13 thousand defective pacemakers that suddenly turn off
In mid-February 2019, Medtronic received a warning from US regulators, according to which it should recall 13 thousand two-chamber pacemakers.
Defective pacemakers of the Adapta, Versa, Sensia, Relia, Attesta, Sphera and Vitatron models are subject to recall. All of them, according to regulatory authorities, may suddenly stop stimulation due to a software error. It is impossible to predict a pacemaker failure, so the FDA attributed the problems to class I problems, that is, characterized by the most serious consequences. Sudden cessation of stimulation can lead to bradycardia, falling blood pressure and clinical symptoms such as dizziness and fainting.
The worst consequence may be a fatality. According to safety data provided by Medtronic, pacemaker failure was observed in two patients, but no fatalities were reported.
According to Medtronic representatives, the main reason for the incorrect operation of pacemakers is the change in the integrated circuit, which was used in the production of many devices. Defective copies were issued from March 10, 2017 to January 7, 2019. The total number of pacemakers released during this period is 13,440 devices.
Medtronic said it is developing software that is designed to solve these problems when upgrading defective device software. This measure will apply only to devices already installed. Medtronic asks doctors to return all unused and unopened products that were produced during the specified period. In addition, the company warned patients with installed pacemakers that if new or unexpected symptoms occur, they should see a doctor immediately.[4]
Recall 157 thousand defective pacemakers. Because of them, the heart stops
In January 2019, Medtronic announced the recall of almost 157 thousand pacemakers sold worldwide. The manufacturer has discovered a problem in this equipment that can cause the patient's heart to stop. Fortunately, no fatalities were recorded.
Some devices operating in certain modes may occasionally lose the ability to maintain a specific heart rate. The reason is due to a change in the design of the integrated circuit.
The recall campaign touched on two-chamber pacemakers under the brands Adapta, Versa, Sensia, Relia, Attesta, Sphera and Vitatron series A, E, G and Q. Defective devices were released on the world market between March 10, 2017 and January 7, 2019.
Not all models under these brands and years of production are recognized as faulty. To find out if a certain device comes under review, you need to enter a serial number from the patient identification card on the official Medtronic website.
Even if the device is on the list of returned to the manufacturer, this does not mean that it is faulty completely - the failure occurs only in one of the 12 programmable modes of operation of the pacemaker.
The heart is able to independently produce electrical pulses and contract under their influence. The constant rhythmic activity of the pump guarantees the pumping of blood throughout the body. There are diseases that cause the heart to work intermittently, resulting in signs of heart failure or sudden death. To maintain the desired heart rate, pacemakers are used, which by the beginning of 2019 implanted more than 1 million people around the world.
Medtronic's recall only affects two-chamber pacemakers, which feed pulses into the upper and lower right chambers of the heart to help them beat in the right rhythm.
Medtronic does not recommend doctors remove devices from patients for preventive purposes, but in some cases may require replacement. For example, if the patient does not tolerate any pacemaker mode of operation that is not confirmed by the problem.
For many patients, the problem can be temporarily resolved if the doctor programs the device to one of 15 modes that are not subject to the defect. It will be possible to completely eliminate the problem by updating the software, which Medtronic will release after approval by regulators. Corrections for pacemakers should be released in the second half of 2019.
The company estimates at 0.021% the risk of death of patients from this shortage of pacemakers. This indicator is comparable to the level of risk of death for patients (0.027%) undergoing surgical surgery to replace the implantable device.
Medtronic emphasizes that any unimplanted recalled devices should be returned to the manufacturer.[5]
Patients whose pacemakers remain in one of the potentially malfunctioning regimens should see a doctor immediately if new or unexpected symptoms indicate that the device is inoperative.
At the time of the recall announcement, four pacing pauses were registered in two patients. A total of 156,957 devices are recalled, of which 12 thousand copies were sold in the United States.
According to Medtronic estimates, the suspension of pacemakers in problem modes is possible in an average of 2.8% of cases per month. Pause can last 1.5 seconds or longer.
2018
Fine of $54.5 million for cheating with the elimination of problems in cardio pumps
On November 16, 2018, Medtronic-based company HeartWare International agreed to pay $54.5 million in compensation for cheating to fix problems in cardio pumps. According to the court order, the manufacturer of medical equipment misled investors about the prospects of MVAD cardio pump and exaggerated the efforts spent on solving the problems that arose with it. More details here.
Medtronic turned off pacemaker software updates over the Internet due to cyber theft risk
In October 2018, Medtronic disabled the update of pacemaker software over the Internet due to the risk of cyber theft. The company notified this in a letter sent to doctors and medical institutions entitled "Urgent correction of medical equipment." More details here.
Hackers Can Disable Medtronic Pacemakers Thanks to Vulnerability
On August 13, 2018, it became known that hackers can turn off Medtronic pacemakers due to existing vulnerabilities in the security system. Carelink 2090 allows you to download malware from an external source, with the help of which hackers can fully control the operation of the device, including disabling it. More details here.
Recall defibrillators and pacemakers
On February 26, 2018, the US Food and Drug Administration (FDA) announced that Medtronic was withdrawing from the market part of implantable defibrillator cardioverters (ICD) and biventricular electrocardiostimulators with cardiopursion-defibrillation function (CPT-ICD) process due to a defect in the production process. More details here.
1960: Creation of an implantable pacemaker
In 1960, Medtronic created an implantable pacemaker, and within two months orders were received for fifty such devices. In the same year, another key event occurred - Earl Bakken developed the mission of Medtronic. Over the past forty years, this document has been translated into many languages.
In the mid-1960s, Medtronic introduced its first pacemaker with transvenous electrode delivery, which made it unnecessary to open the chest and perform general anesthesia. This method has become the basis for the development of similar miniinvasive procedures for other areas.
In the 1960s, further expansion of the company's activities led to the fact that the company became the most diversified company in the world in the field of medical technology development. The experience of electrical stimulation of the heart has been applied to the treatment of other areas and organs of the body.
A gastric electrostimulation device has been developed and a number of research projects have been carried out on the use of stimulation to relieve spinal pain. These projects were "probing" in nature, but turned out to be extremely important for the company, since they made it possible to create a basis for the development of new technologies.
1957: Creation of a portable pacemaker
In the mid-1950s, Earl Bakken met Dr. S. Walton Lilhay, who was one of the first to start open heart surgery at the University of Minnesota School of Medicine. Dr. Lilhey and other surgeons have discovered that in heart surgeries, about 10% of patients experience a blockade of the conduction pathways of the heart. The devices for external pacing that existed at that time were bulky, remote electrodes were used in them and power was supplied from the outlet, which made them useless when the power was turned off.
In 1957, Earl Bakken Earl, together with Dr. Lilhey and his colleagues, created a portable pacemaker powered by a battery and no larger than a small book. This was a breakthrough in the treatment of blockade of the conducting pathways of the heart and other diseases.
The development served as the basis for the creation of dozens of other devices that use the company's experience in the use of electrical stimulation.
Notes
- ↑ Apple magnetic charger, smartwatch may deactivate Medtronic ICD
- ↑ India’s drug regulator warns patients against defective Medtronic pacemakers
- ↑ After patient death, FDA warns of battery depletion in Medtronic pacemakers
- ↑ FDA gives massive Medtronic recall Class I designation
- ↑ Medtronic recalls 157,000 dual-chamber pacemakers
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