Legal Investigation After Problems With Pacemaker Sensors

A patient suffering problems with a Boston Scientific Pacemaker device which is the subject of a field safety notice from the manufacturer as well as the MHRA has instructed specialist product liability lawyers at Irwin Mitchell to investigate.

The patient has suffered serious problems with a Boston Scientific Pacemaker, which he has been told has a software fault.

Boston Scientific has issued a letter to medical practitioners offering advice on how to manage patients following reports of problems with the sensors leading to malfunctions. 

The Medicines and Healthcare products Regulatory Agency (MHRA) has also issued a medical device alert notifying practitioners of the Field Safety Notice from Boston Scientific. It asks medical professionals to identify all patients implanted with the device.

The MHRA notice refers to more than 20 model numbers and six different pacemaker products including Valitude, Accolade, Essentio, Visionist, Proponent and Altrua.

Expert Opinion

“The problem appears to be that the ‘MV sensor’ is oversensitive, which leads to malfunction of the device and associated morbidity.

“Boston Scientific is working on a software fix, which is expected to be available in October 2018. In the meantime, the advice to clinicians is to switch off the MV sensor, which can create physiological problems in itself, as the activity of the pacemaker is altered.

“The recall notice states that 32,500 individuals in the UK are affected, and there have been 8 deaths or serious injuries to date. This is a very serious issue and it is important that it is properly investigated as soon as possible to ensure patient safety for all of those affected.

“We are now working with our client to ensure they get the help and support they need as we investigate the problems they have reported.” Matthew Newbould - Associate Solicitor

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