“Medical device battery fault that have caused two deaths” – Battery defects of the implantable cardioverter defibrillators and cardiac resynchronisation therapy devices causing an adverse effect on patients

Due to a battery issue, medical equipment like implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) have reportedly failed, leading to serious concerns for patient health.

It’s thought that around 350,000 devices worldwide have been implanted and potentially put patient health at risk.

Technical details

Lithium clusters forming from battery depletion can apparently bring about short circuiting, meaning the battery could drain very quickly. They’re supposed to last three months, but are possibly depleting quicker as a result of the problems, putting patient’s health – and lives – at risk.

St Jude Medical published a notice to the public addressing the problem in the last few weeks, with the notice highlighting the affected models. The premature battery depletion associated with the devices manufactured by Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quada are said to be in the mix.

Consequences

There have been two deaths (one in the U.K.) that have been associated with the battery depletion. In those cases, the patients were unable to have their defibrillation therapy as a result of the devices draining out of battery prematurely.

Additionally, there has been ten reported incidents of fainting as well.

St Jude Medical reports that only 0.2% of the affected devices are reported to have experienced the premature battery depletion. Patients with devices implanted for a duration of more than six years have yet to be given any further information about any failure rates, which could put individuals at greater risk of harm.

Devices are reportedly being replaced at no extra cost.

As it seems impossible to predict which devices will suffer from the lithium cluster problem, the job of manufacturer is to recall all devices as soon as possible to have them rigorously tested for the issue. This is important given that it could be a life or death matter if devices fail.

St Jude Medical’s plan of action so far only seeks to replace implanted devices that are nearly reaching its elective replacement indicator (ERI), which they see as the priority when it may be close to the end of life (EOL) of the device.

Large volumes affected

Although the distribution figure of 400,000 may seem nominal, it’s not as straight-forward as it seems.

It’s not just NHS hospitals that are in recipient of the devices. The devices have been distributed among care homes, clinics, education colleges, hospices, independent treatment centres, nursing agencies and private medical practices.

Which is huge.

Acting on professional advice, St Jude Medical has given recommendations regarding the devices. However, they highlighted that individual patients may require individual considerations to be assessed on a case by case basis.

St Jude Medical’s seemingly relaxed attitude in recalling all the affected devices could have harmful consequences for patients. A device that has the potential to cause death should be one that sees stringent prevention methods in place, and watchdogs scrutinising their every move.