Western Health Trust Chief executive warns of faulty pacemakers in the north west

During the January board meeting of the Western Health and Social Care Trust Board, Neil Guckian said: “Boston Scientific issued an urgent fail safety notice on December 12, 2024, regarding the subset of its Accolade family of pacemakers with an increased potential of activating safety mode during telemetry or other normal high-powered operations.

“This is a national issue with 314 affected devices across Northern Ireland. We have reviewed our records and identified that 37 patients in the Western Trust are affected. In reviewing these patients, 10 patients required an urgent box change as this cohort of patients has little or no underlying rhythm and is the most at risk. The Trust has replaced the devices already on site.”

In Boston Scientific’s issue of recall they stated: “The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about the potential need for early device replacement of Boston Scientific Corporation (Boston Scientific) Accolade pacemaker devices, which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy pacemakers.

“While the recall by Boston Scientific identifies a subset of Accolade pacemaker devices with increased risk of entering Safety Mode, the FDA is working with the manufacturer to evaluate the potential risk of this issue in all Accolade pacemaker devices and identify additional mitigation strategies as needed,” it was stated.

You can read Boston Scientific’s issue of recall here: https://www.fda.gov/medical-devices/safety-communications/accolade-pacemaker-devices-boston-scientific-and-potential-need-early-device-replacement-fda-safety