At 3:31am, Lyn Farley felt the first shock.

Two minutes later her dual pacemaker-defibrillator shocked her again — five times.

"It lifted [me] off the bed," the 67-year-old from Karuah in New South Wales told the ABC.

"And then it just kept going off, and off and off."

On that night in July 2015, the powerful electric shock to jolt her heart into action went off 48 times in 38 minutes.

The instrument that was supposed to keep her alive almost killed her.

Key points: Lyn Farley was shocked by her pacemaker device as many as 60 times in one night — most patients don't live past 15 shocks

Lyn Farley was shocked by her pacemaker device as many as 60 times in one night — most patients don't live past 15 shocks The device was made by manufacturer Biotronik, which has denied any systematic failures

The device was made by manufacturer Biotronik, which has denied any systematic failures Doctors that spoke to the ABC said there was a conflict of interest in reporting device failures and a lack of a valid government registry

"I'd pass out some of the time, but it just kept going," Ms Farley said.

"I thought I wasn't going to make it."

The incident was so rare the ambulance had to stop and pick up a specialist paramedic on the way.

Readouts from the device showed, overall, Ms Farley was shocked up to 60 times by the time she got to the hospital.

In most emergency cases patients don't often live past 15.

A large magnet over her chest eventually stopped the device, which, at the time, had been inside her for six years.

In order to stay alive, Ms Farley had to be flown to Sydney and kept on adrenalin for a week until she got a new pacemaker.

"Some of the doctors would laugh because it [went] off so many times," Ms Farley said.

"They said: 'just feel lucky that you're still here'."

The device responsible

Dr Wilsmore said it was "a surprise" Ms Farley's heart was able to keep going after the shocks. ( ABC News: Alison Branley )

Ms Farley's new cardiologist Bradley Wilsmore was astounded by her case.

So he started to investigate.

He found the insulation on one of the three leads, connecting the dual pacemaker-defibrillator to her heart, had eroded leaving the internal wires exposed.

It meant the defibrillator thought her heart had stopped, when it actually hadn't — so one of the other leads was trying to shock her heart back into action.

The area of the fault in Ms Farley's pacemaker lead. ( ABC News: supplied )

The pacemaker and the leads were made by manufacturer Biotronik, based in Germany.

Further investigation by Dr Wilsmore revealed the lead model, known as Linox, had been mentioned in a number of international case reports a year earlier showing similar erosions that led to unnecessary shocks.

Dr Wilsmore reported Ms Farley's case to Biotronik.

"The formal report back was 'there's no lead issues, there's never been any lead issues and we take no responsibility for any lead and it's because we think the lead is fine'," he said.

"I found that very unsatisfactory."

Do you know more about this story? Email Specialist.Team@abc.net.au

When Dr Wilsmore spoke about Ms Farley's case at a medical conference, other cardiologists also reported issues with the product.

He said he treated an elderly man as recently as October last year with a similarly eroded Linox lead who received an unnecessary shock.

"Biotronik just refuse to accept there's a problem," he said.

The insulation around the lead in Ms Farley's pacemaker eroded and exposed the internal wire. ( ABC News: Supplied )

In a statement — which can be read in full here — Biotronik spokesman Roman Borkowski said all devices carried risk, and inappropriate shocks were a "well-known" complication of having a pacemaker-defibrillator.

He said the company had been transparent in its dealings and abided by relevant local regulations.

"Linox leads have received regulatory approvals globally and have not been recalled in any market," he said.

However, according to doctors who spoke to the ABC, the issue stems back to regulation itself.

Registry to track issues a failure in Australia

In Australia, the companies that make heart devices such as pacemakers and defibrillators are required to have internal company databases about their products.

These registries track patients, surgeons, devices and potential side-effects over time to detect problems with products or surgical techniques.

But the information is controlled by the manufacturers, and doctors rely on the companies to notify them of safety concerns.

What happens when an internal defibrillator activates? There are few recorded cases, mainly because it is impossible to know when it's going to happen

There are few recorded cases, mainly because it is impossible to know when it's going to happen But in 2009, video emerged of Belgian soccer player Anthony Van Loo being shocked by his internal defibrillator during a Belgian League game

But in 2009, video emerged of Belgian soccer player Anthony Van Loo being shocked by his internal defibrillator during a Belgian League game After the shock he was able to sit up and was taken to hospital to recover

After the shock he was able to sit up and was taken to hospital to recover After collapsing again in 2018 because of the heart condition he was forced to retire

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Only four companies worldwide make pacemakers and leads.

"It's dependent on the company [releasing the information] who obviously have a vested interest," Dr Wilsmore said.

The Federal Government recognised this potential conflict of interest with device registries back in 2014, and after years of lobbying by patient groups funded two national registries.

One was the breast device registry. The second was the cardiac devices registry which was designed to monitor cardiac stents, valves, pacemakers, defibrillators and similar devices.



In 2017, the Therapeutic Goods Administration commissioned a review of the registry.

The ABC has obtained documents through a Freedom of Information request that show serious problems with the registry's operation.

The registry had just 43 doctors sign up over its five years of operation — a participation rate of less than 5 per cent.

By comparison, the breast device registry has 95 per cent participation.

The review was damning, citing a "low level of engagement" from the Australia New Zealand Society of Cardiac and Thoracic Surgeons, and said the registry "lacks clinical utility" and had "governance issues".

Dr Wilsmore, here inserting a pacemaker, said there was a conflict of interest in the industry. ( ABC News: Alison Branley )

The ABC has discovered as recently as 2019, there was $2.2 million in the federal budget for the breast and cardiac registries, even though emails to surgeons suggest the cardiac registry had all but collapsed.

Professor David Playford, a cardiologist who specialises in registries, said some of the problems stemmed from the highly competitive nature of cardiology, and the clinics that offered it.

"[What they] don't want to do is have a situation where only the bad outcomes are displayed," he said.

Further, he said, the registry was voluntary, so the data collected was not comprehensive.

"Particular hospitals or groups may say 'look I don't really want to share this'."

Complicating the issue is the number of state-based registries and others run by private clinics and colleges, some of whom have concerns about data being absorbed into a national database.

In a statement, Cardiac Society of Australia and New Zealand president Professor Len Kritharides conceded the registry had been unsuccessful.

Ms Farley's pacemaker — not pictured here — is no longer manufactured. ( ABC News: Alison Branley )

He said it was developing a new registry that would collate data from registries run by the states.

"These more recent endeavours have successfully engaged all states and territories with the recruitment of thousands of patients and will allow us to monitor quality outcomes," Mr Kritharides said.

The new registry has a steering committee and its first job will be to create a registry for stent procedures — a form of heart surgery.

Another registry for pacemakers is planned, but not yet in action and will still be voluntary.

Following inquiries from the ABC, a spokesman for the Federal Department of Health said the money in this year's budget was for the new cardiac stent registry, even though the budget papers indicate it was for the device-specific registry.

Damning findings

One New Zealand study into the Linox leads, released in 2018, found "the seven-year survival of [the] leads was significantly worse than shown in Biotronik surveillance reports".

"Canada actually looked at their [own] national registry [in 2014] and showed the failure rates of the Linox lead were five to six times higher than similar leads," Dr Wilsmore said.

"And some other reports indicated there'd been even higher failure rates.

"There is potential for death without notifying us or identifying this early."

Mr Borkowski said the industry, and Biotronik, worked "tirelessly" to reduce the burden of inappropriate shocks on patients, which could happen for multiple reasons.

"The performance of Linox leads is fully comparable with the typical performance of current, non-recalled competitor leads," he said.

"There is no evidence of systematic failure in the Linox lead family or in any other Biotronik leads."

But other patients have also had distressing experiences with the "Linox lead family".

Tom Scutts got a pacemaker-defibrillator in 2011 after his second heart attack.

Tom Scutts was rushed to surgery after his pacemaker shocked him five times. ( ABC News: Elena De Bruijne )

Within a week of getting his new dual pacemaker-defibrillator, things took a turn during a rehabilitation exercise class at the hospital.

"Then all of a sudden, bang, that got me wide awake," he said. "And when I mean shocks, I mean it shocks [the heart]. It is a very powerful feeling.

"I went back and sat there and while I was sitting, it went bang four more times. So I had five shocks."

Mr Scutts was rushed back into surgery.

The culprit was his Linox lead, which hadn't attached to his heart properly.

Again, the device thought his heart wasn't beating, when it actually was.

Warning: Don't be alarmed Patients with pacemakers and defibrillators in Australia will have a card indicating the make and model of their device and its leads

Patients with pacemakers and defibrillators in Australia will have a card indicating the make and model of their device and its leads Dr Wilsmore said if they did have a Linox lead they did not need to be worried

Dr Wilsmore said if they did have a Linox lead they did not need to be worried "The failure rate is still relatively low and in most instances the patients won't know that there is a lead issue," he said

"The failure rate is still relatively low and in most instances the patients won't know that there is a lead issue," he said In most cases, doctors believe it is safer to keep the device and leads implanted, rather than try and remove them

Years later, Mr Scutts said he was grateful for the device — and for the other times it had genuinely saved his life — but it had left him with lasting emotional effects, which led him to see a counsellor.

"It doesn't leave my mind. Even now."

The Linox lead is no longer available for use, having been superseded by a newer model.

But Dr Wilsmore said there were still an unknown number of patients living with the problematic leads.

"There's likely to be hundreds of people [in Australia] walking around with these types of leads [but] we just don't know because we don't have a registry to document it," he said.

Lyn Farley said she never received an apology from Biotronik. ( ABC News: Elena De Bruijne )

For Ms Farley, the aftershocks continue.

It has also impacted her family, who had to call the ambulance and were powerless as the product took over her body.

She now has a standalone pacemaker without a defibrillator, but for months afterwards she couldn't go into her bedroom.

She has given up her hobbies and also needed counselling.

She expected an apology from Biotronik but she said no-one from the company ever got in touch with her.

"It was horrendous," she said.

"I never want to go through it again."