Medtronic Lead Problem

I've been told that telling people to not read further can have the opposite impact (I actually want to use the word affect or effect instead of impact, but I cannot remember which one is right) so instead I'll just say that if you are tired of hearing me talk about work read on at your own risk of boredom. But if you heard the news about Medtronic and wonder how it relates to what I do at work then read on.

Today there were articles in the NYT and Wall Street Journal about Medtronic pulling its ICD (implantable cardioverter-defibrillator) lead off the market. The lead is the group of wires that travels through a vein into the heart. It contains the wires that are used for sensing signals from the heart and the wires used to deliver a shock.

Leads are very troublesome for many reasons, most of which stem from them going into the heart. One reason is that every time the heart beats the lead bends. If you are wondering why this is bad try bending a paper clip once a second for 20 years (or maybe save some time and just imagine it). If a lead breaks the device might detect it, but it can cause the device to become confused causing false shocks, and worst of all it can stop the device from providing appropriate therapy (either by messing up the sensing or not providing an electrical path). Another issue is that leads are really dangerous to remove, because the vein wall grows around them over time and they are often screwed into the heart wall. Sometimes when a new lead is required they will not take out the first one, but instead just put in another one.

Having said this - very often the benefit of a defibrillator out weights these risks. If you have a device, are considering a device or know someone with a device this article should NOT prompt anyone to demand their device be removed or refuse to get one. Discuss the benefits and risks with a doctor who can help with the individual's risk benefit tradeoff. I'm not just saying this to be legally proper, I really believe that it is important to listen to your doctor and to take this report into account, but not be scared by it.

The device the company I work for is designing still has a lead, but it does not go in the heart or veins (it sits just under the skin). So it is not subjected to the same amount of bending (it does bend with breathing, but that is a much smaller movement and less often) and thus is much less likely to fracture. It is also much easier and safer to remove should there be an issue.

You might think that we would have been celebrating that the top company in the field had a failure directly related to what distinguishes our company, but people were actually very good at seeing the big picture that bad things happening to patients is not something to be happy about.

This article mentions that Chenney does have a medtronic ICD, but an older lead model that does not show this issue.