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A Fatally Defective Regulatory System: Nansostim Pacemakers – A Case Study

Boz Michalowska looks at the Nanostim Pacemaker as highlighted by the ICIJ Implant Files Investigation. Boz argues that the history of the device – from product launch to recall – evidences a fatally defective regulatory system that requires urgent overhaul

Bozena is head of the product safety and consumer law team at Leigh Day. She specialises in product liability group actions. 
In a series of reports published by the International Consortium of Independent Journalists (ICIJ), journalists have exposed the potentially fatal flaws in a range of medical products including the Nanostim pacemaker.

The Guardian newspaper, who worked with the ICIJ in uncovering the scandal, reported that the Nanostim pacemaker, brought to market by St Jude Medical and hailed as a revolutionary leadless pacemaker, suffers from malfunctioning batteries.

The Nanostim was the first self-contained intra-cardiac pacemaker to be implanted in a human patient. It was claimed to have an average lifespan of more than 9 years at 100 percent pacing, or more than 13 years at 50 percent pacing.

As such, patients were entitled to have confidence in the device and confidence that the risk of having repeated life-threatening revision operations to replace the device was minimal.

Worryingly faulty pacemaker batteries are nothing new: In October 2016 the FDA in the United States, the US medical device regulator, issued a warning following two deaths in the US connected to premature battery depletion in St Jude Medical Cardiac implantable electronic devices (ICD) including the Fortify, Fortify Assure, Unify, Unify Quadra, Unify Assura and Quadra Assura product ranges. Defective batteries in ICDs are perhaps the most obvious example of how a defective medical device can leave a patient in fatal danger.

ICDs deliver electrical shocks to restore a normal heart rhythm when necessary, using a battery powered pulse generator. If the batteries are depleted, the devices are unable to deliver life-saving pacing and shocks. As such, patients and doctors would be entitled to expect that any ICD released to market had been subject to the most rigorous pre-market testing.

However, reports in the Guardian suggest that the Nanostim was cleared for marketing and given CE approval by the British Standards Institute in 2013 on the basis of only a three-month trial involving just 33 patients, one of whom had died due to a heart perforation during the implantation procedure.

Despite this limited and equivocal pre-marketing data, the Nanostim was released for use in patients in 2013: Less than a year later, the manufacturer, St Jude, were forced to temporarily suspend a Nanostim post marketing release trial after doctors reported six instances of perforation, including two patient deaths.

However, it took until 2016 for the product to be pulled from market, via a Product Safety Alert finally issued by the manufacturer.

The safety alert reported 34 instances of premature battery failure. By 2016 a total of 1423 Nanostim devices had been implanted worldwide since 2013. Even after the formal recall of the product in 2016, problems were still being found with the device.

In 2017, Abbott, who acquired St Jude Medical, issued a further safety notice warning on the Nanostim involving a problem with the docking button that was designed to allow doctors to extract the device.

This included three reports of the button detaching and in one case migrating into an artery. This potted history of the Nanostim device exposes the fact that even with the most high risk medical devices; manufacturers are not required to do the extensive pre-market testing that most of us would presume took place as a matter of course.

The fact that the Nanostim was implanted nearly 1500 times in the 3 years post its release, despite the limited initial testing undertaken and the cascade of problems reported post release – is evidence of a fatally defective regulatory system.

As patients and taxpayers we should be angry about the fact that too often, in a race to get products to market, proper scientific and rigorous pre-market testing is sacrificed in favour of manufacturers’ profit lines.

The UK regulator, the MHRA and the Notified Bodies that are supposed to police market access for products in the UK must do more to ensure that patients aren’t made unwitting guinea pigs in a medical device trial for which they never consented.

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