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Further concerns raised over St Jude Medical heart leads

MHRA issues urgent medical device alert on heart leads

Photo of heart: istock

22 December 2011

The Medicines and Healthcare Products Regulation Authority (MHRA) has today issued an additional urgent medical device alert in relation to all models of the Riata and Riata ST implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical.

These ICD leads work in conjunction with various heart devices for patients with cardiac problems.

At the time of their last alert in December 2010, the MHRA had received 39 confirmed adverse events of patients experiencing inappropriate electric shocks, oversensing caused by noise on the lead, charges in impedance and pacing thresholds and loss of sensing resulting in non-detection of arrhythmia.

Fresh concerns are raised in relation to these products after a report in Northern Ireland has recently revealed that as many as 15% of patients followed up with Riata and Riata ST leads showed evidence of an insulation breach in the leads.

Leigh Day & Co currently represent a number of individuals who experienced problems regarding the St Jude Riata ICD leads.  They also represent a large group of individuals who have experienced similar problems with various Sprint Fidelis model numbers, manufactured by Medtronic Limited.

Leigh Day and product liability claims

Leigh Day & Co’s product liability team has unrivalled experience in dealing with defective product claims and faulty consumer goods claims. It has particular experience in successfully handling multi-party, or group claims, or behalf of people who have been injured by faulty consumer goods, drugs or medical devices. The team is has been top-ranked in the field of product liability by legal directories Chambers guide to the legal profession and the Legal 500 for the last six years.  To speak to a member of the team please contact us on 020 7650 1219 or email Jill Paterson for a free, confidential initial consultation.

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