Medtronic defibrillators

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• Medtronic
• Medtronic defective and dangerous products

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• Medtronic Viva Quad XT CRT-D

2021: Withdrawal of defibrillators defibrillated due to short circuit

In early April 2021, it became known that Medtronic recalls defective implantable defibrillators due to short circuit problems. Class I recall (that is, recall of devices whose malfunction can lead to the death of the patient) concerns 239.2 thousand Medtronic devices.

In total, 444 complaints were received on Medtronic devices. They related to Evera, Viva, Brava, Claria, Amplia, Compia and Visia implantable cardioverter defibrillators (ICD) and cardiac resynchronizing therapy devices (CRT-D), which were on the market from August 31, 2012 to May 9, 2018. Among the 264 reports of cardiac failure in medical devices, 18 were described. There were no reports of fatalities.

Medtronic withdraws defibrillators defibrillators defibrillated due to short circuit

The problem with the devices is a short circuit, which can cause unexpected and rapid reduction in battery life. The time between the first Recommended Replacement Time warning and the full battery discharge can be only one day, while the average time is 14 days.

Medtronic no longer uses this battery design, so ICD devices released since February 2019 are not affected by this problem. Medtronic sent out letters about the need to urgently replace defective medical devices to all its customers on February 3, 2021. As for patients with already implanted devices, the company recommends that doctors conduct routine follow-up according to a local clinical protocol. If the device proposes to replace the battery ahead of schedule, the device must be replaced immediately.

In addition, Medtronic recommends that doctors take advantage of the home CareLink monitoring system and wireless communication CareAlert at low battery voltage, if possible.^[1]

2020: Medtronic unveils new portfolio of implantable cardioverter defibrillators

At the end of January 2020, Medtronic introduced a new portfolio of implantable cardioverter defibrillators (ICD) and electrocardiostimulants with cardioversion defibrillation function (CPT-ICD). The manufacturer's range was supplemented by Cobalt and Crome devices. More details here.

2019

Medtronic agreed with the US authorities to hide data on tens of thousands of complaints about defibrillators

At the end of May 2019, it became known that Medtronic had agreed with the US authorities to hide data on tens of thousands of complaints about defibrillators. More details here.

The government warned of the hacking of hundreds of thousands of Medtronic implantable defibrillators through telemetry

In early April 2019, the Department of Homeland Security USA issued a warning about the existence of vulnerabilities in implantable defibrillators. Medtronic Several hundred thousand devices turned out to be defective.

The problem lies in the patented wireless telemetry protocol used in some implantable cardioverter defibrillators (ICD) and Medtronic biventricular electrocardiostimulators with cardioversion-defibrillation function (CRT-ICD). According to the data received, vulnerabilities in the security system allow attackers to "change or intercept the radio frequency communication of the telemetry system, which can potentially affect the functionality of the product and/or provide access to confidential data transmitted."

Medtronic Implantable Defibrillators Vulnerable to Hacking with Remote Monitoring

In order to break into an ICD, no deep expertise is required. If an attacker gets close enough to intercept a signal, he will only need a device that can transmit or receive Conexus telemetry messages. Once connected, the hacker will be able to read any confidential records and modify them at his discretion.

The second vulnerability threatens less potential damage and only allows the hacker to read information stored on the device, such as the patient's name and health data.

Medtronic reported that by the beginning of April 2019, there were no cases of cyber attacks and privacy violations in connection with these vulnerabilities. Although wireless connectivity can be disabled on devices, the company encourages patients and healthcare providers to continue to use this feature, as the benefits of remote monitoring outweigh the practical risk. The company also noted that it is already working on updates designed to reduce the risk of hacking.^[2]

750 thousand Medtronic defibrillators can be disconnected at a distance of 6 meters

On March 21, 2019, the Food and Drug Administration (FDA) reported the existence of a vulnerability in Medtronic implantable defibrillators, due to which attackers can remotely interfere with the operation of devices, including turning them off.

The malfunction was detected in two dozen cardioverter defibrillators, and the total number of defective products can reach 750 thousand.

Hundreds of thousands of Medtronic defibrillators are vulnerable to hacking

The problem is that medical devices do not require wireless authentication, as a result of which attackers can disturb the patient's heart rate by changing the device settings or by issuing a direct command to the defibrillator. This can lead to serious health problems, up to death.

The vulnerability is associated with the proprietary Medtronic Conexus Radio Frequency Telemetry Protocol, which serves as a wireless connection to implanted devices. According to Clever Security experts, the problem is the lack of encryption during data transfer. As a result, an attacker in the range of the radio signal (up to 6 meters) can intercept communications. Moreover, the protocol does not implement an authentication mechanism for legitimate devices to confirm that they have the right to control implanted defibrillators, Clever Security said.

Medtronic confirmed the problem, but reported that the benefits of remote monitoring outweigh any risks associated with these security flaws. The manufacturer began to solve the problem and emphasized that the company is not aware of the operation of these vulnerabilities. Medtronic defibrillators are automatically disabled if they receive any unusual commands.

The FDA does not recommend the use of defective devices. For them, the manufacturer is developing an update that eliminates vulnerability.^[3]

2018

Medtronic recalls defibrillators that threaten patients' lives

At the end of September 2018, Medtronic received two warnings from the US Food and Drug Administration (FDA) and recalled some heart rate control products from the market.

During the Medtronic inspection from April 23 to May 14, 2018, the regulator discovered several defects in the production process that could threaten the life and health of patients. As part of the investigation, the FDA inspected two Medtronic production facilities in Minnesota and Puerto Rico and found deviations at both sites. The problems concerned two products - nine models of a device for resynchronizing cardiac therapy with defibrillation and twelve models of an implantable cardioverter-defibrillator. In addition to deviations from production standards, the management noted that the devices do not monitor their activity, as a result of which it was impossible to evaluate their performance.

Medtronic defibrillator

Since the sites could not immediately solve the identified problems, Medtronic voluntarily recalled these models from the market, informed suppliers about the need to replace defective devices and took up internal inspection. It turned out that defects lead to the unexpected formation of a gas mixture inside the device, which can disrupt its operation, namely, block the electrical signal sent to the patient's heart when it stops.

These models were established for 48 patients whose condition is closely monitored and cases of device failure that could lead to severe complications or death have not yet been noted. However, another 526 Medtronic devices were withdrawn from the market and disposed of.

In the warning letters, the FDA also presented possible corrective and preventive measures and recommended instrumentation and testing equipment to assess their effectiveness. Medtronic reported that it has fully solved all identified problems and is awaiting re-inspection.^[4]

First Medtronic defibrillator implanted with wires outside heart and veins

At the end of August 2018, Medtronic announced that it had begun clinical trials of a new extravascular implantable cardioverter-defibrillator. Traditional pacemakers and defibrillators send an electrical signal to the heart and vessels thanks to thin implanted wires. This allows you to point the signal, but can lead to various complications, from equipment failures to valve damage and the development of infections. An extravascular cardioverter defibrillator will avoid such problems.

The Medtronic device has the size and shape of traditional ICDs and is designed for a similar ten-year battery life. Extravascular ICD is implanted under the skin of the left axillary cavity, and guide wires pass under the bone base with the thorax, but do not directly touch the heart or veins. In September 2018, such an apparatus was implanted in the first patient.

Medtronic implanted the first extravascular ICD whose wires envelope the heart

Medtronic is not the first company to manufacture such equipment - in 2012, Boston Scientific launched a device called Emblem ICD on the market. But Emblem can only perform cardioverter-defibrillator functions, while the new Medtronic device is also an implanted rhythm driver. This allows you to prevent episodes of ventricular fibrillation, reduce the frequency of defibrillations and save charge.

Medtronic has been testing the new ICD for many years and publishing data on its potential use, and has now begun the first experimental clinical study. They will be attended by 20 patients from hospitals in Australia and New Zealand, who will be regularly examined for the safety and effectiveness of the device.

If satisfactory results are obtained, Medtronic will proceed to the next stage - a reference clinical trial, the results of which will be submitted to regulators for registration of the device in the market. But so far it is too early to talk about the approximate timing of the start of sales.^[5]

Recall defibrillators and pacemakers due to improper composition of the gas mixture

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.

The FDA reported that this defect is due to the improper composition of the gas mixture inside the device, which may prevent the device from transmitting the electrical impulse needed to maintain the patient's heart rhythm or resuscitation in cardiac arrest.

Medtronic recalls defibrillators and pacemakers

On January 22, 2018, Medtronic sent a notification to all interested persons - patients, guardians and medical professionals involved in the installation of these devices - about the device's withdrawal from the market due to a technological error. The notification reported that ICD and CRT-ICD with NIK and LWS codes produced between July 13, 2013 and August 8, 2017 are being withdrawn - a total of 48 devices across the country. All affected patients were advised to contact the treating doctor about the possible installation of a temporary pacemaker, as well as contact Medtronic representatives to discuss warranty obligations.

Medtronic also proposed expanding warranty obligations for damaged devices in general. Patients who have questions or need additional advice may contact Medtronic Patient Services. Treating physicians and patients themselves can report the occurrence of unwanted reactions or other problems through an FDA program that collects data on unwanted MedWatch events. This can be done online via website, regular email or fax.^[6]

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