Medical Device Alert For St Jude Defibrillator Implants

Manufacturer Issues Notice On Products


The Medicines and Healthcare Regulatory Agency, the UK's regulator of medical devices and pharmaceuticals has issued a medical device alert for the Ellipse TM VR/DR implantable cardioverter defibrillator.

The alert, which applies to model numbers CD1277, CD1377, CD2277 and CD2377, has been issued in response to reports of insufficient electrical charge in the affected models, thought to be caused by a faulty capacitor.

Implantable Cardioverter defibrillators (IDCs) are used in patients who suffer from abnormal heartbeat, otherwise known as arrhythmia. Arrhythmia can lead to cardiac arrest in some patients if preventative action isn’t taken. ICDs work by monitoring heart rhythm and administering electric shocks to the heart to get the heartbeat back to normal.

A number of the reported models have been found to either fail to charge at all, or to have too little charge to administer an effective shock. In a patient with dangerous arrhythmia, that could result in a cardiac arrest.

The MHRA has issued guidance to physicians not to implant any of the affected models and to recall patients who have already been implanted for analysis of the device. It is not yet known how many patients will be affected by the recall.

Matthew Newbould, a legal expert in Irwin Mitchell's product liability team who specialises in cases related to defective products, said: "It is disappointing that further problems have come to light with St. Jude cardioversion devices. Our team currently represents a number of claimants affected by the St. Jude Riata lead, the part of an ICD which administers the shock.

"Some of those leads have been found to be poorly insulated, causing continuous and unnecessary electrical stimulation of the heart, with serious consequences in some cases.

"Manufacturing standards for medical devices, which can mean the difference between life and death, should be exacting. Although the manufacturer has acted responsibly in requesting a prompt recall, problems like uninsulated wires and faulty capacitors really should not be an issue in modern medical devices.

"It is vital that steps are taken to ensure, where possible, lessons can be learned from these issues to improve safety standards in the future."

Our specialist personal injury solicitors could help you claim compensation if you or a loved one has suffered due to a faulty defibrillator. See our Faulty Defibrillator Claims page for more information.