Cobalt (defibrillators)

2022

Recall of another 22,110 defibrillators that failed

On August 11, 2022, it became known that the company Medtronic was recalling 22,110 implantable cardioverter-defibrillators (ICD) Cobalt and Crome and defibrillators for resynchronization therapy (hearts CRT-D) in. USA

According to the FDA, the Class I recall is associated with a potential reduction in impact energy during high-voltage therapy for Cobalt and Crome and CRT-Ds ICDs.

Medtronic recalls defective defibrillators

Some devices gave out only about 79% of the energy parameters envisaged, which Medtronic estimates reduces efficiency by 1%. Medtronic has received no reports of irreparable harm to health or deaths related to the issue.

Medtronic does not recommend replacement of implanted devices. The software update is expected to fix the problem in existing and new implants. Medtronic has also asked medical facilities to return some non-implanted devices for inspection.

After obtaining FDA approval and CE labeling for a software update, Medtronic began rolling out an update in August 2022 to reprogram implanted devices in healthcare settings and pre-install them on new devices.

Medtronic has warned doctors to set these devices to maximum power (40 J); when programming to maximum power, the impact on the efficiency of devices in the event of a problem will be minimal (for example, from 99% efficiency to 98% efficiency), the company said in a statement.

Medtronic's similar Class I recall of ICDS and CRT-D devices in 2021 covered 239,171 devices due to potential battery life issues related to more than 400 complaints about Medtronic's Evera, Viva, Brava, Claria, Amplia, Compia and Visia devices.^[1]

Medtronic recalls defective implantable defibrillators

In mid-July 2022, Medtronic announced the recall of defective implantable defibrillators due to the fact that the devices can emit electrical pulses below the programmed force during therapy.

As stated in the notification published by the Federal Institute of Medicines and Medical Devices of Germany, the recall concerns several models of Cobalt, Cobalt XT and Crome devices from Medtronic. These include implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D).

ICDs constantly monitor heart rhythm and periodically supply electrical discharges to restore heartbeat and eliminate any abnormalities, while CRT-D devices operate similarly to a standard pacemaker and direct electrical impulses to the right and left ventricles to coordinate contractions. The CRT-D implant may also send a shock wave into the heart to interrupt a dangerously fast heart rhythm. In its notice to medical facilities, Medtronic said it found a flaw in some devices that could cause them to emit electrical pulses below the programmed force during high-voltage therapy. The company says that this force drops to about 79% of the programmed energy, which could lead to a 1% decrease in the efficiency of defibrillators.

Cobalt XT implantable defibrillator

In the event of a fault, the devices will automatically issue a short-circuit protection warning. This warning could be misinterpreted by doctors, the device developers said, which could lead to unnecessary and risky replacement of the device or related components. As of early June 2022, Medtronic announced that it had received reports of 27 devices, which is only 0.03% of the approximately 80,000 implants distributed around the world that emitted these low-energy shocks. None of these cases have been linked to reports of permanent damage or death.

However, Medtronic estimates that the number of affected devices could eventually reach 0.18% of the number used as of July 19, 2022, as the likelihood that a patient will need high-voltage therapy and the likelihood that there will be a decrease in energy increases over time. The device manufacturer does not recommend replacing implants. The developers cite data showing that the risk of death from device replacement complications is 0.032% to 0.043%, a relatively low risk that still far exceeds the 0.002% probability of death estimated by Medtronic due to a technical issue.

Instead, the company recommends that healthcare professionals continue to perform remote monitoring and regular checks of devices in clinics, reprogramming them to the maximum possible voltage if necessary so that unplanned voltage reduction still provides a significant electric shock.

Medtronic said the company has also submitted a software update for regulatory approval to address the issue. The update is expected to be available for download on implanted devices in the third or fourth quarter of 2022. Medtronic added that medical facilities that have unused ICDs and CRT-D devices that match certain serial numbers should quarantine the implants and return them so that the company can check them for compliance with the necessary production specifications.^[2]

2020: Announcement

At the end of January 2020, Medtronic introduced a new portfolio of implantable cardioverter-defibrillators (ICDs) and cardioversion-defibrillation electrocardiostimulators (CPT-ICDs). The manufacturer's range has been expanded by Cobalt and Crome devices.

ICDs control heart rate and interfere when collecting a rhythm that can lead to sudden cardiac arrest. CPT-ICD is a treatment option for people with heart failure that sends small electrical impulses to the ventricles of the heart, allowing them to beat in a synchronized mode and reducing symptoms.

Medtronic unveils new portfolio of implantable cardioverter defibrillators (ICDs)

Cobalt and Crome include Medtronic's TriageHF technology, which the company describes as a simplified, integrated automation tool that assesses patient changes that could lead to worsening heart failure and hospitalization. TriageHF breaks patients down into three risk categories (high, medium, or low), assessing factors such as heart rate variability, the presence of atrial fibrillation, and blood congestion. TriageHF is compatible with all Medtronic ICD and CPT-ICD devices with Medtronic OptiVol blood stagnation monitoring function, including those already used by patients.

The company also said it had incorporated several "smart" features into its new implants. For example, iATP is an automated algorithm that adapts to an irregular heart rhythm and attempts to correct it with painless stimulation. BlueSync technology allows implanted devices to interact with the CareLink SmartSync device manager for physicians and the MyCareLink Heart mobile app for patients. The EffectivCRT and AdaptivCRT algorithms available on the new CPT-ICTs allow therapy to be adjusted according to each patient's minute-by-minute heart rate estimates.^[3]

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