Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many patients have been affected by the recall of certain Boston Scientific CRT-P pacemakers (a) nationally and (b) within Somerset; what assessment has been made of the potential impact of this on NHS resources; and who is responsible for covering the costs of device replacement and associated care.

The Medicines and Healthcare products Regulatory Agency (MHRA) is closely monitoring the Boston Scientific Accolade Field Safety Corrective Action (FSCA) to ensure it progresses safely.

The FSCA affects 13,969 pacemaker patients at 153 sites in the United Kingdom, who have an increased risk of their pacemaker switching to “Safety Mode”. This represents approximately 14% of UK Accolade Pacemakers.

The Department is aware of two deaths associated with this malfunction, both of which occurred outside the UK, and resulted from injuries sustained from fainting following a malfunction.

Risk mitigation advice includes evaluation of patient devices and revision surgery for those with four years or less longevity remaining. While some devices may need earlier replacement than would have been expected, the risk to patients is low and affected patients are being reviewed locally by expert clinical teams, often as part of routine follow-up processes.

Musgrove Park Hospital’s pacing service, which includes the fitting of pacemakers, has been minimally affected, less than five patients, by the recall of the Boston Scientific CRT‑P pacemakers.

In most cases, the trust uses alternative pacemaker products, including Biotronik and Abbott devices. As a result, the recall has had minimal impact on services and patient care, but MHRA will continue to keep this under review.

The commissioning of pacemaker devices does not fall under the direct commissioning remit of NHS England. Given the benefits of trying to achieve a nationally coordinated response, NHS England worked with professional bodies and NHS Supply Chain to encourage an equitable approach from Boston Scientific relating to both additional device costs and the impact of additional activity.