Faulty pacemakers ‘killing 2,000 a year’

A THIRD of unexpected deaths among heart patients with pacemakers and similar devices could be caused by malfunctions, research suggests.

Scientists say there is evidence the implants could be a ‘leading cause of mortality’ and warn the findings are a ‘major concern’.

More than 40,000 patients are fitted with pacemakers in the UK a year, with another several hundred having Implantable Cardioverter Defibrillators (ICDs). In total, a quarter of a million people have the devices in the country.

Both are tiny battery-powered devices inserted into the heart to keep the rhythm regular. But Uni- versity of San Francisco academics, who looked at 517 patients who suffered a sudden death, found that 30 per cent of cases were caused by mechanical flaws.

These included batteries running out, the implant being programmed incorrectly or the wrong type being fitted.

Around 14,000 patients die in the UK each year having been fitted with a pacemaker or ICD – of whom half die suddenly after having been in relatively good health.

This means that if the figures discovered by the American researchers also applied to this country, the implants would be to blame for more than 2,000 deaths a year. Professor Zian Tseng, who led the research, published in the Journal of the American Medical Association, 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.’ He added that there was ‘an urgent need for a systematic surveillance of problems.’

Dr Paul Roberts, a cardiology consultant based at 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 the healthcare profession and industry learns from these failures.’

The Medicines and Healthcare products Regulatory Agency – the watchdog for medical devices – said there were 2,400 reports of ‘adverse incidents’, including deaths, from pacemakers and ICDs between 2010 and 2014.

But it also pointed out they save at least 50,000 lives a year as without them patients would die from sudden heart attacks.

A spokesman added: ‘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.’