Medtronic confesses that defibrillator wires are failing, while FDA smiles and goes back to sleep

A fairly good article is here.

the article in the Wall St. Journal is pretty cagey about what is going on. It seems that five patients have died as a result of the failed wires, although we may never know what criteria were used to determine which patients (of the thousands whose wires broke) died as a result of the event. What we do know, from the WSJ article, is that the FDA boasts of having a ‘much more cooperative relationship with the company…” Somehow, that makes me nervous. Because if you do the math, it seems that 2.3 % of these wires failed: If roughly 250,000 were implanted, then something like 5500-6000 of these wires broke before the company, let alone the slumbering FDA, seemed to notice.

The company said it has learned through 30-month performance data that the [wiresl] had begun to fail at a greater rate than [another type of wire].

These broken wires cannot be removed, according to the article. So we have over 200,000 people with these time bombs ticking, 5 already dead, and 5500 broken wires; and the FDA is happy.

Peachy.

The linked article makes it clear that this has been a concern for months. Exactly how many more people got these wires put in them in the meantime is not yet clear. I certainly hope we find out.  I’m sure Medtronic is not going to give them any refunds.

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Filed under gadgets, George W. Bush: is he really THAT bad?, healthcare

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