Hospitals are having to update more than 100,000 patients’ pacemakers – and replace hundreds of the devices – after the manufacturer discovered their batteries run down years early, HSJ has learned.
Medical device manufacturer Boston Scientific issued a field safety notice to trusts in December 2024, which stated that around 13 per cent of its Accolade pacemakers manufactured before September 2018 have a battery flaw.
It means they are more likely to suddenly switch into a limited, back-up “safety mode”, which can be fatal for some patients who are fully reliant on their pacemaker.
Estimates of the numbers affected in the UK have never been issued, but the Medicines and Healthcare products Regulatory Agency has now told HSJ that 13,969 devices affected by the flaw were sold to 153 hospitals in the UK.
In addition, last autumn, Boston Scientific issued a software update for the problem, which it said should be made via in-person appointments. The MHRA said this means a further 97,557 devices across 308 UK hospitals, in addition to the initial 13,969, should be updated.
Acute trusts are now in the process of calling in the patients affected, HSJ has learned.
Date: 2 March