Medtronic, a Minnesota based company, is the largest manufacturer of heart implant devices, both in the United States and worldwide. This makes them a pretty important company which creates problems when something goes wrong. Since October, they have stopped selling a specific type of lead because of the potential for electric shock or death due to a defect in the leads.
The Leads
Medtronic's Sprint Fidelis leads are at issue in this recall. The leads are the tiny wires that go from the battery pack to the heart in both pacemaker devices and ICD devices. They monitor the heart's rhythm and deliver a shock from the battery pack when one is necessary. Leads are anchored in the heart which makes replacing them a risky process.
The Sprint Fidelis leads were the thinnest leads ever sold by Medtronic. They have a diameter of a few small millimeters. Unfortunately, this thinness makes them susceptible to breaking. When the leads break, the patient is then more likely to receive an unnecessary shock or no shock when one is necessary.
The Product
Sprint Fidelis leads were mainly used in Medtronic's ICDs (Internal Cardioverter Defibrillator). They have been on the market since 2004. They have been used in roughly 268,000 ICDs since the leads went on the market in2004.
Medtronic estimates that 5,000 people will have problems with their leads in the next 30 months. This gives them a rate of roughly 2% of all leads and ICD implants. While that does not sound like a lot of people to most individuals, to a company with a reputation to protect, that is way too high. It is also important to note that that is 5,000 people who could possibly die because the device that was implanted to save their life didn't work because its leads broke.
In response to this rate of breakage, Medtronic has pulled all un-implanted leads from the shelves. They are also recommending that people not replace leads unless it is certain that the leads are broken since the replacement process is so risky.
The Problem
As already stated, the problem with the Sprint Fidelis leads is that they are breaking at a rate higher than expected. With any product on the market, it is safe to assume that at least one of that product will be defective in some way. For this reason, companies generally figure out the rate of breakage and factor that into their development and testing estimates.
The broken leads for Medtronic mean that two outcomes are possible when the leads break. The first option is that the leads will tell the battery pack that a shock is necessary when one isn't. This results in the heart receiving a shock when it doesn't need one. While the heart can handle this, it is still extremely painful for the recipient of the shock. The second option is that the leads will not deliver a shock when one is needed. Because the ICD is meant to shock the heart back to a regular rhythm rather than letting it run away with a fast rhythm or no real rhythm. If the heart is allowed to beat this way, it can lead to the heart stopping completely. This can lead to death.
Medtronic, a Minnesota based company, is the largest manufacturer of heart implant devices, both in the United States and worldwide. This makes them a pretty important company which creates problems when something goes wrong. Since October, they have stopped selling a specific type of lead because of the potential for electric shock or death due to a defect in the leads.