Man sues over faulty heart device

Doctors for a man, suing the makers of an allegedly faulty heart defibrillator, believe that removing the device now would pose a greater risk than leaving it in place.

Barrister Doireann O’ Mahony told the High Court that 41-year-old mechanical fitter Patrick McCarthy, Curragh Rd, Turner’s Cross, Cork, still had the cardio implant in his chest.

Mr Justice John Hedigan heard Mr McCarthy is suing cardiologist Gerard Fahy; South Infirmary Victoria Hospital Ltd, and Medtronic Ireland Ltd and several of its Irish associate companies for alleged negligence and breach of duty.

Mr McCarthy had a Medtronic implantable cardioverter defibrillator (ICD) implanted in August 2007 .

Medtronic and five associated defendants it is claimed are allegedly responsible for the design, production, manufacture, marketing and sale of the Medtronic “Sprint Fidelis” leads used in the defibrillator. Mr McCarthy further alleges Medtronic in March 2007 had been aware of alleged device defects and had issued a warning concerning the Sprint Fidelis leads, but permitted them to be used in the ICD implanted in him. The defendants deny all the claims .

Ms O’Mahony told the court her client claimed the Sprint Fidelis leads tend to fracture thereby blocking or distorting their electrical flow to the heart.

Mr McCarthy further claims in October 2007 the Irish Medicines Board had confirmed that almost 1,200 people here had been fitted with the same type of heart defibrillator linked to five deaths in the US. At the time Medtronic suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads and recalled any unused leads.

Mr Justice Hedigan granted Mr McCarthy a number of orders covering discovery of documents limited to information within the remit of the defendants in Ireland. He rejected demands for worldwide discovery relating to Medtronic and associated companies.

The case will return to court later in the year.