Has Your Pacemaker Entered Safety Mode? What This Means for Your Health and Legal Options

Has Your Pacemaker Entered Safety Mode? What This Means for Your Health and Legal Options

Recent FDA safety communications have brought attention to a disturbing problem affecting many patients with Boston Scientific pacemakers: the sudden onset of pacemaker Safety Mode. This feature is meant to preserve life during critical device failures – but when triggered by a manufacturing defect, it can put patients at serious risk of injury or even death. If you’ve experienced symptoms or been told your pacemaker has entered Safety Mode, you need to understand what this means for your health and your legal rights.

The affected devices include models from the ACCOLADE™ family and others manufactured before September 2018. These include the ACCOLADE, ESSENTIO™, PROPONENT™, and ALTRUA™ 2 pacemakers, as well as VISIONIST™ and VALITUDE™ CRT-Ps. A manufacturing defect affecting the battery cathode can cause the device to suddenly enter Safety Mode, disrupting heart rhythm regulation and requiring urgent surgical replacement.

What Is Pacemaker Safety Mode and Why Is It a Problem?

Safety Mode is a built-in response designed to provide emergency backup pacing if a Boston Scientific pacemaker undergoes repeated system resets – typically three or more within a 48-hour period. However, patients implanted with affected models are experiencing these resets due to a heart device battery defect caused by excess lithium salt in the cathode.

When Safety Mode activates, the device reverts to non-programmable pacing settings. This mode was never meant for prolonged use – it provides limited pacing functionality, often inadequate for individuals who are pacemaker-dependent. According to Boston Scientific’s advisory, this has led to pacing pauses, fainting, and in at least two reported cases, death.

Once triggered, Safety Mode cannot be reversed. The pacemaker must be surgically removed and replaced. The urgency is especially high for patients reliant on the device for AV/VV pacing or those with underlying heart failure.

Who Is at Risk? Affected Devices and Patient Populations

Not every Boston Scientific pacemaker is impacted, but a significant number – over 200,000 devices – were built before September 2018 using the flawed battery component. The FDA classified this recall as a Class I recall, indicating a risk of serious injury or death.

The following models are affected:

• ACCOLADE DR, SL, EL, and MRI models
• ESSENTIO DR and EL models
• PROPONENT DR and VDD models
• ALTRUA 2 DR SL and EL
• VISIONIST and VALITUDE CRT-Ps

Boston Scientific estimates that roughly 13% of these devices may enter Safety Mode due to latent high battery impedance. Many devices enter this mode during in-office telemetry, but in some cases, it has happened spontaneously – outside clinical settings – leading to catastrophic outcomes.

If you were implanted with one of these devices prior to late 2018, you should speak to your cardiologist about whether your device is among those flagged. You can also check the model and serial number using Boston Scientific’s lookup tool online.

Recognizing Symptoms and Emergency Risks of Safety Mode

One of the most dangerous aspects of Safety Mode is that it may activate without any prior warning. Patients may not immediately realize their Boston Scientific pacemaker recall device has failed unless they experience new or worsening symptoms. In the most serious cases, this can lead to a medical emergency before the issue is even detected.

Symptoms that may indicate your pacemaker has entered Safety Mode include:

• Lightheadedness or dizziness
• Shortness of breath during regular activities
• Fainting or sudden loss of consciousness (syncope)
• Chest pain or discomfort
• Noticeable irregular heartbeats or palpitations
• Muscle twitching or phrenic nerve stimulation (e.g., chest or abdominal spasms)

If your symptoms started suddenly, especially during or shortly after a routine device check, your pacemaker may have been triggered into Safety Mode by telemetry communication. In about 70% of known cases, this has occurred during in-office interrogations with the LATITUDE™ system.

Importantly, the Safety Mode settings are fixed. The pacemaker reverts to a unipolar sensing and pacing configuration with a fixed rate and disabled magnet response. This lack of customization may not be adequate for your specific pacing needs and may lead to inadequate cardiac support.

Legal Help for Pacemaker Injuries – Do You Have a Case?

Patients injured as a result of a pacemaker device failure may be eligible for a defective pacemaker lawsuit. The manufacturing issue at the center of this recall-excess lithium salts in the battery cathode-has caused substantial harm to real people. If your device entered Safety Mode and you required emergency intervention, or if you suffered harm because of the reduced pacing function, you may have a valid legal claim.

These types of claims may involve:

• Medical costs related to pacemaker replacement surgery
• Hospitalization following a cardiac event linked to Safety Mode
• Pain and suffering for emotional distress and physical trauma
• Loss of income due to recovery time or disability
• Wrongful death damages for family members of deceased patients

While Boston Scientific has acknowledged the manufacturing flaw and issued recommendations, the company may still be held liable for injuries caused by its defective devices. Our lawyers can investigate your case and determine whether you’re entitled to compensation.

How Alonso Krangle, LLP Can Help Patients Affected by Pacemaker Device Failure

Our team is currently reviewing claims related to the Boston Scientific pacemaker recall. If you have one of the listed models-especially those implanted before September 2018-you may be entitled to legal relief. Even if you haven’t experienced symptoms yet, the mere fact that your device is at risk may warrant evaluation.

We can help you by:

• Reviewing your pacemaker records and serial/model information
• Helping you document medical visits and adverse symptoms
• Determining whether your device is part of the advisory population
• Explaining your rights under product liability and medical device law
• Filing claims against the manufacturer and guiding you through the legal process

Injuries from pacemaker device failure are serious, and we take them seriously. The law allows patients harmed by defective medical devices to pursue damages-especially when the company knew of the risks and delayed meaningful corrective action. The FDA classified this as a Class I recall, the most serious level, because of the risk of injury or death. That means time is of the essence.

If you’re unsure whether your pacemaker qualifies, we can help you use Boston Scientific’s device lookup tool or obtain the necessary documentation from your medical provider. We’re here to guide you every step of the way.

Speak With Our Lawyers Today – Get the Help You Deserve

If your pacemaker has entered Safety Mode, or if you have experienced symptoms that may be related to a failing Boston Scientific device, don’t wait to get answers. You may be living with a defective device that could jeopardize your health at any moment.

We are already helping individuals like you determine their legal rights and explore compensation for what they’ve endured. These are complex medical device claims that require an understanding of both healthcare impacts and legal obligations. Our firm knows how to build these cases and advocate aggressively for the people harmed by corporate negligence.

Contact Alonso Krangle, LLP today to speak with our lawyers about your situation. If you or a loved one may have been affected, call us at [PHONE] or complete the form on this page for a free consultation. There are strict time limits to file a lawsuit, and in cases involving federal recalls, the statute of limitations can be complex.

Your health and safety matter. If your pacemaker has entered Safety Mode, we’re here to help.