Scotsman.com
EBEN HARRELL
Key points
• 28,000 pacemakers worldwide suffering quality control problem
• Seals can degrade, causing moisture to build up and the pacemaker to fail
• Many fitted with device face difficult decision on how best to proceed
Key quote
“The health and safety of patients is paramount. Our innovative technologies have saved and improved millions of lives. Guidant works diligently to create the most reliable products and services, enhance patient outcomes and limit adverse events to patients.” - RONALD W DOLLENS, GUIDANT
Story in full SCOTTISH heart patients are at the centre of a new alert over life-saving cardiac devices after a US company said nine of its pacemaker models are prone to failing. Many patients may now need to have the units surgically replaced.
The alert from the Guidant Corporation follows a six-week barrage of recalls and product alerts that have now seen health warnings on around 20 different Guidant models, affecting more than 100,000 patients worldwide. Guidant patients in the UK are already having surgery to replace devices. Thousands more face a difficult decision on how to proceed.
Aberdeen cardiologist Dr Paul Broadhurst said: “At our hospital, we’ve already surgically replaced two [devices] based on previous alerts. Now we’ll go through it again with pacemaker patients and make the decision on how to proceed.”
The current alert covers 28,000 pacemakers made from November 1997 to October 2000. Guidant said the pacemakers’ seals could degrade, causing moisture to build up and the devices to fail. The company said this may have contributed to several patients’ deaths.
Guidant said doctors should consider replacing the affected pacemakers in patients who are “pacemaker dependent”.
While some patients use a pacemaker only in times of abnormal heart rhythm, around 20 per cent of patients have no underlying heart rhythm at all and so depend on the device for life.
The Medicines and Healthcare products Regulatory Agency (MHRA) - the UK government body that regulates the industry - confirmed it is evaluating the problem. “We are in contact with Guidant,” a spokeswoman said.
The MHRA could not confirm how many UK patients are fitted with the pacemakers, but Guidant said 10,000 devices are fitted in patients outside the US, many of whom are in Scotland.
The pacemaker alert follows recalls in recent weeks of tens of thousands of implantable heart defibrillators. A Scotsman investigation revealed a delay of three years before the company told British doctors and health watchdogs about problems with one of those models.
Around 2,200 UK patients with internal defibrillators were told by MHRA to see their doctor and consider what to do. One option, already taken by many patients, was to have the device surgically replaced.
The US Food and Drug Administration (FDA) recently escalated its recall of four Guidant device models to class 1 - its most urgent alert - saying flaws in 42,000 defibrillators could be deadly.
Both pacemakers and defibrillators are implanted under the skin. A pacemaker, about the size of two 50p pieces held together, regulates a heart that is beating too fast or too slowly. A defibrillator, three times the size of a pacemaker, emits an electrical shock to jolt a stopped or abnormally beating heart back to rhythm.
Nine older pacemaker models are involved in the current alert. They are the Pulsar Max, the Pulsar, the Discovery, the Meridian, the Pulsar Max II, the Discovery II, the Virtus Plus II, the Intellis II and the Contak TR. The company said the units have not been implanted for the last four years.
Guidant said it had identified 69 devices that may have had the seal problem, out of some 78,000 devices manufactured. In 20 known cases, the problem caused pacemakers to fail, and in five such instances, patients lost consciousness. The flaw may have also caused a pacemaker to keep pacing at a high rate, putting a potentially fatal strain on a weak heart.
Because pacemakers need replacing every seven to ten years, many of the pacemakers at issue will need to be replaced soon anyway, since their batteries are nearly drained. The company will reimburse the NHS for any replacements and also reimburse patients up to £1,438 for medical expenses.
In June, The Scotsman revealed that Guidant did not notify British doctors for three years about a defect in one defibrillator model, the Ventak Prizm 2 Dr. The device tended to short-circuit when needed to save a patient’s life. Two US patients died when Ventak Prizms failed during cardiac arrest.
Dr Broadhurst said: “What you really want is not to rely on what the company tells you. But then again, you don’t want to know about every little problem that isn’t significant. I think the Guidant recalls have shown that something needs to change.”
The MHRA is investigating how Guidant handled reporting its products’ performance rates. Since the Ventak Prizm recall in June and under scrutiny by The Scotsman, the company has issued alerts or recalled 11 models of defibrillators.
The deluge of Guidant recalls have led many cardiologists to question when and how device makers alert physicians, patients and regulatory agencies to product flaws.
Although medical devices must initially pass testing by agencies such as the FDA and MHRA, neither body tests devices after approval.
Ronald W Dollens, CEO of Guidant, said in a statement: “The health and safety of patients is paramount. Our innovative technologies have saved and improved millions of lives. Guidant works diligently to create the most reliable products and services, enhance patient outcomes and limit adverse events to patients.”