Research from the US suggests as many as 2000 deaths every year could be caused by problems with pacemakers and electrical heart transplants
According to reports a large scale study conducted in the US has found that the deaths of thousands of patients could have been caused by problems with pacemakers and electrical heart implants.
The study involved post mortem examinations of 517 patients fitted with electronic cardiac implants, such as pacemakers and implantable cardioverter defibrillators called ICDs which are fitted to help regulate faulty heart rhythms, who suffered a sudden death.
It found implant failures account for up to 30 per cent of these deaths. The study identified device flaws including hardware failures, dead batteries, lead fractures, inappropriate programming or the wrong device used.
According to the Sunday Express newspaper up to 14,000 people with electronic heart devices die in the UK every year. The implants are used by up to a quarter of a million patients, with 50,000 more being implanted annually.
The article concludes that as many as 2,000 deaths a year in the UK could be as a result of failures of these devices. Professor Zian Tseng, led the research. A cardiologist and electrophysiologist, he is an expert in determining the risk of patients prone to sudden cardiac death (SCD) and ventricular arrhythmias.
Professor Tseng said: “This study shows that a leading cause of mortality in the developed world could be attributed to heart device problems, which is a major concern. In many cases these devices are saving lives but we assume they are infallible and they are not.”
The professor, from the University of San Francisco, said there was “an urgent need for a systematic surveillance of problems” adding “Current passive surveillance efforts may underestimate device malfunction.”
The Medicines and Healthcare Products Regulatory Agency watchdog says there were 2,400 reports of “adverse events” linked to electronic heart implants between 2010 and 2014.
Thomas Jervis, a lawyer in the Consumer law and product safety team at Leigh Day, who has represented many people who have alleged that they have been fitted with a faulty implant, said:
“The importance of medical devices such as heart leads and pacemakers cannot be denied and are a vital part of treatment in many cases. However, patients should be able to expect that these products have been developed and tested to the very highest standards before being implanted into vulnerable people who have life-threatening illnesses.
“It is about time patients were no longer being used as guinea pigs for medical devices and that more robust pre and post marketing assessment of them was conducted.”
Leigh Day represented Christopher Pitt, a 69-year old from Hampshire who won an out-of-court settlement from one device manufacturer after suffering 35 life-threatening 750-volt shocks from a heart implant.
Mr Pitt, a father-of-two, was taken to hospital where the device was deactivated. He then underwent surgery to replace the implant and has since experienced more problems with his heart rhythm.
He said: “The problem is a doctor in one part of the country does not know that a doctor in another part of the country has experienced problems with a device. "There is no proper monitoring of these implants when things go wrong.”