In October, Medtronic Inc., makers of a wide range of medical devices, issued a voluntary suspension of its Sprint Fidelis defibrillation leads due to an increasing rate of lead fractures.

Rob Clark, Medtronic senior director of public relations, says the decision was based on both a statistical trend in Sprint Fidelis viability and a problem with the design leading to a greater chance of fracture.

“We decided to remove the product or suspend distribution of the product because, while the performance of the Sprint Fidelis is not statistically different from another lead that we have on the market, the Quattro, the research suggests that it will be different over time. With that information, as well as the fact that the manifestation of these fractures can be inappropriate therapy delivery or inappropriate shocks to the patient, we determined that it was best to suspend the distribution of this product.”

Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire, or lead, that is connected to the heart.

The Sprirt Fidelis went on the market in 2004. Since that time, out of 268,000 implanted leads, five deaths were reported with lead fractures as a possible contributing factor.

Lead fractures can be caused by many factors. The patient may engage in heavy exertion or other activities that could contribute to a fracture. Or, when the defibrillator is implanted, it may be bent in such a way that the device leaks and overtime develops a fracture. In the case of the Sprint Fidelis, the design of the product is faulty.

“We have identified and are working on a few design-related matters where we think we can improve the device. We plan to bring those improvements forward, complete our testing, [and] submit it to the FDA with the hopes of having a small defibrillator lead back on the market within 12 to 18 months,” says Clark.

Medtronic has no reason to believe that manufacturing standards or processes have any thing to do with the problems with the device. Clark points out, “This device is manufactured along the same types of procedures, the same types of testing, the same types of diligence and scrutiny that we use for our commercially available lead called the Quattro, which has a better than 99 percent survivability rate. Our belief is that there are primarily these two fracture areas where we think we can improve via design."

To maintain a standard of responsibility, Medtronic communicated, via letter and direct outreach with more than 13,000 physicians worldwide, the Sprint Fidelis lead performance data and updated patient management recommendations for patients who are implanted with Sprint Fidelis leads.

Although the FDA is considering Medtronic’s action a product recall, it is the recommendation of the FDA, Medtronic, and the Heart Rhythm Society that the patient should keep the device implanted unless there is a specific fracture that’s been identified.

“For the those patients that have Fidelis implanted, we know that through the remote monitoring systems and the reprogramming of the device... we can sense the device fractures earlier in the process, both to minimize or avoid inappropriate therapy being delivered. Also, by reprogramming the software in the device when the lead hits a certain threshold, it will alarm the patient so they will hear that beep and they will know to contact their physician.”

For more information, visit wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1192213397218&lang=en_US