Boston Scientific Pacemakers: High Battery Accolade Family and CRT-Ps Recall

Boston Pacemakers: Legal Advice for Patients

A safety notice has been issued concerning a subset of pacemakers from the ACCOLADE family of devices manufactured by Boston Scientific before September 2018. Approximately 13% of these devices have an increased potential to initiate a non-programmable safety mode due to latent high battery impedance. This issue could pose significant risks to patients relying on these devices. If you or a loved one have been affected, Fletchers Solicitors is here to provide expert legal advice and support.

Understanding the Boston Scientific Pacemaker Recall

The advisory devices were identified based on battery cathode processing techniques used by specific manufacturing operators. These techniques have been linked to a higher concentration of lithium salts, which increase the risk of devices entering safety mode during telemetry or other higher-power operations.

Key concerns include:

• Non-programmable safety mode pacing parameters may not adequately support a patient’s cardiac condition. This includes issues such as insufficient pacing for cardiac synchrony and potential pacing inhibition due to oversensing.
• Two reported deaths have occurred in pacemaker-dependent patients implanted with advisory devices that initiated safety mode in an ambulatory setting.

Boston Scientific has stated that devices within the advisory population are no longer available for implantation, and contemporary manufacturing techniques have improved battery performance.

Actions Being Taken Following the Recall

Boston Scientific has issued recommendations to mitigate risks for affected patients, including:

• Writing to treating clinicians of affected patients to advise on appropriate steps.
• Development of a software update to detect early signs of high impedance battery states, aiming to provide alerts before safety mode activation.

For some patients, clinicians may recommend pacemaker replacement. While this aims to reduce risks, it could result in:

• Increased frequency of replacements over a patient’s lifetime.
• Greater risk of scar tissue, pain, and potential complications.
• Heightened anxiety for affected individuals and their families.

Boston Scientific Pacemakers: Legal Advice and Support

Christian Beadell, Head of Group Actions at Fletchers Solicitors, has stated:

“For patients who have received the Accolade pacemaker or one of its variants prior to 2018, the safety notice issued by Boston Scientific is likely to cause immense concern. In line with the guidance issued by the manufacturers, recipients of the affected devices should be reviewed by their clinicians who can advise them on how best to proceed. In some cases, this is likely to result in them suffering avoidable harm.”

If you or a loved one have been impacted by this recall, Fletchers Solicitors can help you explore your legal options. We understand the stress and uncertainty this situation may cause and are committed to providing compassionate, expert legal support. We have a particular expertise in Medical Device Claims: Our experienced Group Actions team specialises in helping clients affected by faulty medical devices and treatment, ensuring access to justice and fair compensation.

Medical Product Liability Experts

Our medical product liability team include Partner, Sarah Samuel, and Partner, Lisa Lunt. The team have over 20 years of experience in clinical negligence, and more than a decade specialising in medical product liability group actions. This experience has seen Sarah and Lisa bring forward many successful claims against major pharmaceutical and medical device manufacturers.

Learn more about the work Sarah and Lisa are doing to support clients who are affected by the Boston Scientific Pacemaker Recall.

If you have received an ACCOLADE pacemaker or one of its variants before 2018 and are concerned about the safety notice, our dedicated team is here to help. Call us today for a free initial consultation to discuss your case and find out how we can support you.