FDA Raises Alert Following Boston Scientific’s Caution on Early Pacemaker Replacement
In a recent announcement, Boston Scientific (NYSE: BSX) revealed the potential necessity for earlier-than-anticipated replacements of specific pacemaker models. This alert prompted the FDA to issue a notice to healthcare providers.
Earlier this month, Boston Scientific informed its clients about identified concerns related to certain batches of the Accolade, Proponent, Essentio, and Altrua 2 dual-chamber standard and extended life pacemakers, along with Visionist and Valitude cardiac resynchronization therapy pacemakers (CRT-Ps). The identified devices have shown an increased risk of switching to “Safety Mode” during telemetry and high-power operations due to heightened battery impedance, leading to insufficient power delivery owing to a production fault.
Reports received by the company mention two fatalities in pacemaker-dependent individuals whose devices initiated Safety Mode in non-hospital settings.
The likelihood of encountering this issue rises as the product approaches four years of remaining battery life. As a result, none of the affected devices are still available for initial implantation.
When a device enters Safety Mode, its functionality is restricted, potentially affecting its ability to accurately modulate a patient’s heart rhythm, according to the FDA. Devices that move into this state necessitate complete replacement. In response, Boston Scientific intends to refine the manufacturing instructions connected with battery cathodes of the Accolade models and plans to produce a software update to consistently monitor battery health across all Accolade pacemakers.
Boston Scientific highlighted that about 13% of the devices from the Accolade family, particularly units manufactured prior to September 2018, are impacted. The company remains firm in its dedication to patient safety, actively working to update physicians and healthcare experts with the crucial information needed for optimal patient management.
According to a statement to MassDevice, a Boston Scientific representative explained: “A voluntary product advisory has been issued for a select group of pacemakers and CRT-Ps due to the possibility of these devices moving to Safety Mode from increased internal battery impedance. This condition could present later in the device’s life span, possibly necessitating an earlier replacement for specific patients. Currently, none of the devices impacted by this advisory are available for new implantations. Physicians monitoring patients with the highlighted devices have been provided with recommendations to minimize the risk and might reach out directly for a further examination of their patient’s equipment.”