Hundreds of Suffolk patients warned their pacemakers could malfunction
PUBLISHED: 16:00 01 February 2019 | UPDATED: 16:35 01 February 2019
Pacemakers fitted to hundreds of Suffolk patients may be at risk of malfunctioning, it has emerged.
Ipswich Hospital is warning people that devices manufactured by global firms Medtronic and Vitatron have a potential risk of not working properly.
The cardiology department issued letters this week to approximately 250 patients fitted with an affected pacemaker in the last two years.
Consultant cardiologist Dr Paul Venables said the risk of any serious problem is very low – adding that there has been “no reports of anyone dying” in more than 150,000 affected pacemakers.
However one patient, who preferred not to give his name, said he was shocked when he received the letter.
“It was a shock, I must confess – it (the letter) just came out of the blue,” he said.
“A few things they said in the letter did concern me, especially the bit they mentioned about no-one dying yet.
“It sounded a strange thing for them to say, I was a bit surprised. “It’s worrying to think there might be a problem.
But he added: “The hospital have been really good so far, and I’m going back for a check up soon so that’s good.”
Hospital spokeswoman Jan Ingle said the wording was meant to be reassuring, adding that the trust was sorry for any upset caused.
Dr Venables, who penned the letters, has invited all patients back to the hospital to make adjustments to their devices.
He told this newspaper: “Medtronic has discovered that some types of pacemaker manufactured in the last two years have a potential risk of not working properly.
“We have around 250 patients who have these types of pacemakers.
“We have written to every one of our patients affected and explained that the risk of a serious problem is very low, and there have been no reports of anyone dying (in more than 150,000 affected pacemakers).
“We want to be certain that all of our patients are safe and we are seeing all patients who may be affected within the next two weeks.
He added: “When necessary, pacemaker programming changes will be made to ensure safety.
“It is unlikely that patients will need to undergo a change of pacemaker.”
A software upgrade should resolve the problem, Dr Venables said, but this is only due to be available later in the year.
Exact timings for the upgrade are yet to be confirmed.
Another patient, who also did not want to be named, raised concerns about this and said: “We don’t know when it will happen, in the letter it just says later this year so it’s all a bit up in the air.”
Representatives for Medtronic said: “We recently learned that a design change made to some of our pacemakers can cause a circuit error that may lead to a pause in pacing.
“While most devices are not affected, all patients with affected devices can have them reprogrammed to a mode that will prevent a pacing pause.
“Out of a total of 156,957 devices sold worldwide (approximately 12,000 in the US), we have received reports from clinicians of two patients who experienced a pacing pause related to this circuit error.
“No deaths have been reported.
“Some, but not all, pacemakers with the brand names Adapta™, Versa™, Sensia™, Relia™, Attesta™, Sphera™, and Vitatron™ A, E, G, and Q series, and distributed between March 10, 2017, and January 7, 2019, are affected.
The spokesman added: “Patients can determine if their device is affected by calling their physician, or by entering their device serial number, found on their patient ID card, on our website.
“People may need to visit their clinic for a device check and non-invasive reprogramming.
“Medtronic has provided recommendations to physicians for managing patients with affected devices, including device programming options that eliminate the issue.
“The company, along with its independent physician panel, does not recommend prophylactic device replacement in most cases, since device reprogramming eliminates the potential for the issue to occur.”
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