Pacemakers

Pacemakers are implantable medical devices used to regulate abnormal heart rhythms by delivering electrical impulses to the heart. These devices are commonly used to treat conditions such as bradycardia and other arrhythmias, helping patients maintain a stable heart rate. While pacemakers are essential to modern cardiac care, concerns have been raised about whether certain models may pose serious risks to patient safety.

Siskinds LLP and its Québec-based affiliate, Siskinds, Desmeules, have launched a proposed class action on behalf of Canadians who were implanted with certain pacemakers manufactured by Boston Scientific and who suffered injuries and complications associated with these devices.

Canadian class action alleges defective pacemakers

The class proceeding alleges that certain Boston Scientific pacemakers are defective in design and/or manufacture, particularly with respect to their internal battery systems, and that the defendants failed to adequately warn patients and healthcare providers of the risks.

In particular, it is alleged that these pacemaker devices:

• Contain battery defects that can lead to increased electrical resistance and premature depletion;
• Are prone to entering an irreversible “Safety Mode,” which limits or alters pacing functionality;
• May lose the ability to provide appropriate cardiac pacing, particularly in patients who depend on the device; and
• Require surgical replacement once Safety Mode is activated.

The class action further alleges that the defendants knew, or ought to have known, about these defects based on internal testing, adverse event reports, regulatory recalls, and safety advisories, yet failed to take adequate steps to correct the issues or provide sufficient warning. It is also alleged that safer alternative designs or manufacturing processes could have reduced or eliminated these risks.

Pacemaker products involved in the class proceeding

The proposed class action includes a range of Boston Scientific pacemaker and cardiac resynchronization therapy devices, including:

• Accolade and Accolade MRI
• Altrua 2
• Essentio and Essentio MRI
• Proponent and Proponent MRI
• Valitude and Visionist CRT-P
• Advantio
• Ingenio and Ingenio MRI
• Vitalio
• Invive, Inliven, and Intua CRT-P

These devices have been the subject of multiple recalls and advisories, including large-scale recalls affecting more than 1.6 million devices globally related to battery defects and Safety Mode activation.

Injuries and complications linked to pacemaker failure

When a pacemaker enters Safety Mode or otherwise fails to function as intended, patients may experience serious and potentially life-threatening complications.

Reported complications associated with defective pacemakers include:

• Pacemaker syndrome (including dizziness, fatigue, and shortness of breath)
• Heart rhythm disturbances (arrhythmias, bradycardia, or asystole)
• Syncope (fainting) and fall-related injuries
• Loss of atrioventricular synchrony or pacing inhibition
• Worsening heart failure
• Complications from corrective or replacement surgeries
• Blood clots, stroke, or heart attack
• Infection, bleeding, or surgical complications
• Psychological distress related to device failure
• Death

These risks may require urgent medical intervention, including surgery to replace the implanted device, and may arise even in patients who were otherwise stable following implantation.

Our class action lawyers are here to help

If you or a member of your family was implanted with a Boston Scientific pacemaker, you may be part of this class action.

Siskinds’s class action team can:

• Review your medical history and determine whether you may be included in the proceeding
• Help identify the specific device implanted
• Gather the evidence needed to support your claim
• Pursue compensation for injuries and losses suffered

Are you part of the pacemaker class action?

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_{By emailing Siskinds, I agree that I have read and accept the Privacy Notice and Terms of Use, and I understand that my personal information will be collected, used, and/or disclosed (“processed”) to respond to my inquiry.}