Australian medical recall patients angry at heart-felt failure

Date: Dec 05, 2011

A global medical technology company responsible for the production of implantable defibrillators is at the heart of a controversial oversight that saw a number of Australian patients missed in a vital recall.

It is claimed that the devices – produced in 2005 and recalled in 2007 – were subject to a number of faults that made the wires attached directly to the cardiac muscles prone to fractures.

This could, in turn, cause the device to short out and fail – or lead to unnecessary electric shocks.

The parent company MedTronic has been involved in a number of lawsuits over the pain and suffering experienced by victims implanted with the defibrillator – with one saying that the random shocks were like shotgun blasts to the chest.

Worldwide there were 268,000 patients fitted with one of these devices – and around 1,500 in Australia – before the flaw was recognised and the implants recalled.

Authorities say that at least 13 deaths had been directly linked to the defibrillator by 2009, as the units were not capable of keeping the hearts of the victims beating in a regular rhythm.

One of the big issues faced by the patients implanted with these devices is that – while they relied on them to keep their circulation going in the event of irregularities – the shocks applied are completely random in nature.

For many people this means they are reliant on an implant to keep them alive – but the unit may give them a massive zap at any point in time.

Ongoing cases in the US and UK have been based around these issues – with some victims requiring ongoing hospitalisation and therapy for treatment of post-traumatic stress disorder (PTSD).

PTSD is a condition that is often seen in veterans returning from a war-zone rather than a patient who needs an implanted defibrillator to keep their heartbeat steady.

However, while victims in other countries have since had their devices removed or replaced, the recall notice somehow managed to go unnoticed in Australia.

One patient recently opted to have her defibrillator removed at her own expense after experiencing years of random shocks that saw her spend two periods in the mental health ward at her local hospital.

Independent senator Nick Xenophon told the Sunday Mail that the case highlighted the need for stricter protocols and that the obligation “should be on the manufacturer”.

Xenophon asserted: “Someone implanted with a dangerous device should not have to rely on a Google search to find out about it.”

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