EXCLUSIVE: Experts warn faulty heart implants could be killing 2,000 UK patients a year

FAULTY pacemakers and electrical heart implants are causing the deaths of thousands of patients, research suggests.

Now experts are calling for much greater awareness of the flaws which can develop in the devices.
A large-scale study has found implant failures account for up to 30 per cent of the sudden deaths of patients fitted with them.
This adds up to as many as 2,000 deaths a year in the UK where they are used by up to a quarter of a million patients, with 50,000 more being implanted annually.
The devices include pacemakers and implantable cardioverter defibrillators called ICDs which are fitted to help regulate faulty heart rhythms.

SHOCKS: Christopher Pitt, 69

Professor Zian Tseng, who led the new research, 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”.
The US study involved post mortem examinations of 517 patients with electronic cardiac implants who suffered a sudden death.
It identified device flaws including hardware failures, dead batteries, lead fractures, inappropriate programming or the wrong device used which it concluded were directly linked.
The study report, in the Journal of the American Medical Association, concluded: “Current passive surveillance efforts may underestimate device malfunction.”

Patients should be able to expect that these products have been developed and tested to the very highest standards before being implanted

Tom Jervis, a spokesman for law firm Leigh Day

Up to 14,000 people with electronic heart devices die in the UK every year.
Half of these deaths happen suddenly and of these 30 per cent could be related to malfunction of the device.
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.
Two years ago Christopher Pitt, a 69-year old former company director from Hampshire, won an out-of-court settlement from one device manufacturer after suffering 35 life-threatening 750-volt shocks from a heart implant.
He recalled that the shocks, on Christmas Day in 2008, were “very painful, paralysing and terrifying. I thought I was dying.”

Mr Pitt, a father-of-two, was taken to hospital where the device was deactivated. He then underwent surgery to replace the faulty 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.”
Tom Jervis, a spokesman for law firm Leigh Day, which helped Mr Pitt win his legal action, said.
“Patients should be able to expect that these products have been developed and tested to the very highest standards before being implanted.
“It is about time we had more robust pre- and post-marketing assessment of them.”
Heart specialist Dr Paul Roberts, of the University of Southampton, said: “The technology moves forward very quickly and there have been significant advances that have improved patients’ quality and length of life.
“Inevitably, occasionally, the technology fails us.
"It is important that the healthcare profession and industry learns from these failures.”
A spokesman for the Medicines and Healthcare Products Regulatory Agency said: “Cardiac implantable electronic devices enhance and, in many cases, save the lives of approximately 50,000 patients in the UK each year.
"Without these devices, patients would be at seriously increased risk.”
The three main electrical heart implant manufacturers supplying devices to the UK all declined to comment.