The US Food and Drug Administration (FDA) is alerting patients and healthcare providers about the potential need for early device replacement of Boston Scientific Accolade pacemaker devices.
This includes the Accolade, Proponent, Essentio, Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and Visionist, and Valitude cardiac resynchronisation therapy (CRT) pacemakers.
Accolade devices are a family of pacemakers and CRT pacemakers used to treat abnormal heartbeats (arrhythmias) and moderate to severe heart failure.
Boston Scientific recently announced a recall for a subset of Accolade pacemaker devices due to an increased risk of permanently entering Safety Mode.
In Safety Mode, the pacemaker’s functionality is limited, which can prevent it from properly regulating the heart’s rhythm and rate in some patients.
According to the FDA, a device that enters Safety Mode should be replaced. The issue is linked to a manufacturing defect causing the battery to underpower the system.
The health agency is working with Boston Scientific to assess the risk of Accolade pacemakers entering Safety Mode. While the recall targets a specific subset of devices, the FDA evaluates all Accolade pacemakers to determine if additional mitigation strategies are necessary.
FDA said this communication aims to raise awareness of the recall notice, the FDA’s ongoing evaluation with the manufacturer of the issue, and the current recommendations of the health regulator.
Boston Scientific reports two deaths in pacemaker-dependent patients with devices from the affected subpopulation that entered Safety Mode in an ambulatory setting.
The medical technology company noted the risk increases when the device has about four years or less of remaining battery life. No devices from the advisory population are available for implant.
Boston Scientific plans to update manufacturing procedures for cathodes used in Accolade pacemaker batteries. In addition, the manufacturer aims to develop a software update to monitor battery health across all Accolade pacemakers.
The issue affects about 13% of Accolade devices built before September 2018.
The health agency advised that patients with Accolade pacemakers should work with healthcare providers to monitor their devices, either remotely or in-office.
If the device enters Safety Mode, discuss replacement options, report any issues, and consult a provider about symptoms or concerns.
In October this year, Medtronic announced a voluntary recall of MiniMed 600 series or 700 series insulin pumps due to a potential issue with shortened battery life.
