Medtronic Lead Fracture
If you have a heart defibrillator by Medtronic that uses Sprint Fidelis leads, you are no doubt familiar with the Sprint Fidelis recall issued because the leads, or wires, have a higher rate of failure. Many patients have suffered from a Medtronic lead fracture leading to an additional surgery to implant a new defibrillator lead.
The defibrillator, which is designed to regulate an irregular heartbeat caused by conditions such as ventricular tachycardia or ventricular fibrillation, monitors the heart beat and delivers a jolt of electricity if it detects an abnormal rhythm or rate. When the lead breaks, however, the defibrillator can deliver a jolt even when the heartbeat is normal. It can also fail to deliver a jolt when the heartbeat is abnormal.
Nearly a quarter million people in the U.S. currently have defibrillators with Sprint Fidelis leads. While Medtronic says that only 3-6% of the leads malfunction, other studies indicate that a much higher percentage will malfunction in the next four years.
While it is possible to replace the leads, the lead removal procedure is complicated and potentially risky. Tissue sometimes covers the leads making them difficult to extract. Doctors agree that it may be safer to leave functioning leads in place.
Still, for patients who have a Medtronic lead fracture, replacement is usually recommended, unless the patient is extremely fragile, and the surgery and recovery would take away a significant amount of the patient’s expected lifespan.
If you and your doctor do want to have your leads removed, it is essential to find experienced surgeons to handle the procedure. Of the 13 people who died as a result of the Sprint Fidelis leads, four deaths are a consequence of lead extraction.
The Heart Rhythm Society, an organization of arrhythmia experts, says that there are currently too few doctors with the experience necessary to do the lead extraction procedure. This is will no doubt become of greater concern if there is indeed an increase in malfunction of the leads.
For now, the Heart Rhythm Society says, patients seeking extractions should look for medical centers that have trained doctors to complete many successful extractions. Doctors should perform at least 40 extractions under supervision before doing the surgery independently. A supervising doctor should complete 75 extractions with a high rate of success.
The Heart Rhythm Society also recommends that a national database be established that would have success and failure rates of hospitals conducting this surgery, as a way of helping physicians establish better protocol for success.
In the meantime, patients can ask their medical center its success and failure rate.
If you have a Sprint Fidelis lead, please contact us. We represent all Medtronic fracture clients on a contingency basis, which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free or fill out our short online contact form and a Medtronic recall attorney will contact you to answer any of your questions regarding the ongoing litigation and filing deadlines for a Medtronic lawsuit.