Boston Sci Slapped with Safety Communication for Accolade PacemakersBoston Sci Slapped with Safety Communication for Accolade Pacemakers

FDA yesterday published a safety communication indicating the potential need for Boston Scientific Accolade pacemaker devices to be replaced early after finding a manufacturing issue with the battery cathode.

Boston Sci initially announced a recall for a subset of Accolade pacemaker devices with an increased risk of permanently entering safety mode — a power mode which has limited functionality and has been associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients. The risk of permanently entering safety mode in this subset of devices was reported to be linked to the battery underpowering the system because of a manufacturing issue. The company wrote in the recall that a device that enters safety mode should be replaced.

However, now FDA is alerting patients, caregivers, and healthcare providers that it is working with the company to evaluate the potential risk of the issue affecting all Accolade pacemaker devices, including the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy pacemakers.

As safety mode can only be identified through office visits or through remote monitoring using the Boston Sci Latitude Communicator system, FDA is recommending patients work with their providers to either start remote monitoring of the device or implement an in-office monitoring schedule to help ensure the device is functioning as it should. Patients are recommended to consult with a healthcare provider if they have new or worsening symptoms such as lightheadedness or loss of consciousness.

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If monitoring indicates that the device has entered safety mode, physicians should discuss a plan with users for surgery to replace the pacemaker in a timely fashion. Of note, FDA has said that general prophylactic device replacement is not recommended. Providers are also being told to review the Boston Sci recall notice.

FDA said it is working with Boston Sci to help ensure awareness of the issue and to evaluate information to better understand the problem and identify addition mitigation strategies.

The company, according to the safety communication, plans to implement updated manufacturing work instruction for the process used to make the cathodes for Accolade product batteries and is developing a software update to detect battery health in all mentioned pacemaker devices.