Concerns Raised Over Manufacturing Error Impacting Defibrillator Function

St Jude Medical has issued a medical device alert to medical practitioners and the Medicines and Healthcare products Regulatory Agency (MHRA) relating to a manufacturing problem for Optisure Dual Coil Defibrillation leads.

The alert, which applies to models LDA220Q/52, LDA220Q/58, LDA220Q/65 and LDP220Q/58, has been issued following the discovery that the safety of the insulation surrounding the lead in a small number of the devices has been compromised during the manufacturing process, which may result in the loss of defibrillation therapy during attempted shock delivery.

The Optisure Dual Coil Defibrillation leads connect to an Implantable Cardioverter Defibrillator, (ICD), or a Cardiac Resynchronisation Therapy Device, (CRTD). These devices are used in patients who suffer from abnormal heartbeats, otherwise known as arrhythmia, and administer electric shocks to restore a normal heart beat. In patients with dangerous arrhythmia, a failure in the device could result in cardiac arrest.

Although St Jude claims it is not aware of any complaints or clinical incidents relating to this matter, over 450 devices are thought to be affected by the problem.

The device alert confirms that all patients who have been implanted with the Optisure leads are to be monitored by their Cardiologist, following instruction from St Jude. In some cases, removal and replacement of the leads may be necessary to ensure patient safety.

Matthew Newbould, a Solicitor and legal expert in Irwin Mitchell’s product liability team who specialises in cases related to defective medical devices, said:  

If you or a loved one has been injured or fallen ill due to a faulty medical device or medicine, our medical negligence claims team could help you claim compensation. View our Defective Medical Device & Medicines Claims page for more information.

Expert Opinion

This isn’t the first St Jude defibrillation product to be subject to a voluntary safety warning or recall. The St Jude Riata and Riata ST leads were withdrawn in 2012 because of a greater than expected rate of fracture, leading to failure and unnecessary shocks. In 2014 the St Jude Ellipse ICD was recalled because of a capacitor issue which, in some cases, meant that it failed to charge and could not administer a potentially lifesaving shock. <br/> <br/>“The Medical Device Alert describes the cause of the problem as ‘a trim technique to remove excess medical adhesive around the shock coil’. It is concerning that issues like this are continuing to occur in the manufacture of these such devices which are, after all, a matter of life and death to patients. <br/> <br/>“Steps need to be to improve safety standards, in the hope that devices like this no longer expose patients to the risk of serious injury. Matthew Newbould - Associate