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Medical Device Alert: Ellipse Implantable Cardioverter Defibrillators

MHRA issues medical device alert relating to St Jude Medical defibrillators

Pacemakers regulate the heart beat

17 September 2014

The Medicines and Healthcare products Regulatory Agency (MHRA), the government agency responsible for regulating medicines and medical devices, has issued a medical device alert concerning Ellipse VR/DR implantable cardioverter defibrillators (ICDs) manufactured by St Jude Medical.

The Ellipse ICD has been identified as having potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault. Affected ICDs will exhibit extended charge times during device testing and when preparing to deliver therapy.

Analysis so far has indicated that it is not possible to predict which ICDs will suffer the failure or when it may occur. A list of affected models can be found on the MHRA website.  

The  potential failures reported to date have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events. 

The manufacturer of the implant, St Jude Medical, has recalled the affected devices from hospitals. Whilst there have been no reported cases of a device failing to deliver therapy to a patient when needed, it is recommended that any device that has experienced repeated, extended charge timeout warnings should be considered for replacement. Such patients may have possible claims for compensation.

The product liability team at Leigh Day represent claimants who have suffered inappropriate shocks from ICDs manufactured by St Jude Medical and Medtronic

The firm is recognised as a top tier defective products firm by the two main legal directories, the Legal 500 and Chambers guide to the legal profession, and has the specialist expert knowledge necessary to bring group claims for those injured by defective medical devices.  

If you have been injured, or suffered other losses as a result of faulty medical implants you may be entitled to compensation.  

To speak to one of our specialist solicitors please call or email Jill Paterson on 020 7650 1219 for a free, confidential initial consultation.

Information was correct at time of publishing. See terms and conditions for further details.

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