The FDA has issued a safety communication regarding Boston Scientific’s Accolade family of pacemakers, highlighting the potential need for early device replacement. This alert addresses patients, caregivers, and healthcare providers who may be impacted by manufacturing-related issues that can lead to device failure.
What is the problem with these pacemakers?
Boston Scientific identified a manufacturing defect in the battery cathodes of certain Accolade pacemakers. This issue may cause the devices to enter Safety Mode permanently. Safety Mode significantly limits the pacemaker’s functions and can prevent it from effectively regulating the heart’s rhythm and rate in some patients. If a device enters Safety Mode, replacement surgery is necessary.
The affected models include the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, as well as the Visionist and Valitude cardiac resynchronization therapy pacemakers. Boston Scientific has issued a recall for devices at increased risk of entering Safety Mode and is implementing manufacturing process changes to address the cathode defect.
What should patients and caregivers do?
Monitoring Instructions
The FDA emphasizes the importance of monitoring these devices either remotely or through in-office visits. Patients are advised to work with their healthcare provider to establish a suitable monitoring schedule that aligns with their individual pacing needs. Remote monitoring via Boston Scientific’s Latitude Communicator system can help detect critical issues, such as a Safety Mode alert.
If monitoring indicates that the pacemaker has entered Safety Mode, immediate consultation with a healthcare provider is required to plan replacement surgery.
Symptoms to Look For
Patients experiencing new or worsening symptoms, such as lightheadedness or loss of consciousness, should contact their healthcare provider promptly. Symptoms could indicate device performance issues and warrant further evaluation.
Reporting Concerns
Patients, caregivers, and healthcare personnel should report any problems related to these devices to the FDA. The agency encourages using the MedWatch Voluntary Reporting Form for consumers or established user facility reporting procedures for healthcare personnel.
What steps should healthcare providers take?
Follow FDA Guidelines
The FDA advises against general prophylactic device replacement but recommends monitoring affected devices closely for Performance Mode alerts and patient symptoms suggestive of device malfunction. If a device enters Safety Mode, timely surgical replacement is strongly recommended to mitigate risks.
Evaluate Individual Risk
Providers should collaborate with patients to discuss their unique pacing requirements and assess their risk of harm should the device malfunction. High-risk patients may require proactive intervention and device replacement.
Stay Updated
Healthcare providers are encouraged to remain vigilant for updates and recommendations from the FDA and Boston Scientific, as the situation continues to evolve.
Summary and Next Steps
The FDA has identified serious safety concerns with Boston Scientific’s Accolade pacemakers, particularly due to increased risks of entering Safety Mode. Patients, caregivers, and healthcare professionals are urged to remain proactive in monitoring these devices and addressing potential symptoms or alerts promptly. Timely reporting and compliance with FDA recommendations are critical for ensuring patient safety.
Disclaimer
This article is informational and not legal or medical advice. Professionals should consult FDA guidance and their organization’s regulatory protocols.