Medtronic Sprint Fidelis Lead
IF FAULTY LEADS CONNECTING YOUR DEFIBRILLATOR TO YOUR HEART HAVE PUT YOUR LIFE AT RISK, THE SEARCY DENNEY LAW FIRM CAN HELP PROTECT YOUR RIGHTS
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A defibrillator is a miracle device to anyone who has suffered a heart attack or has a serious heart condition. If life-threatening irregular heartbeats occur, an implanted defibrillator automatically delivers a shock to slow the pace down and restore normal heart rhythms.
Defibrillators are life-savers . . . when they work. But what if they don’t?
In October 2007, physicians across the country were alerted to a voluntary recall of one brand of critical elements that make a defibrillator work – Sprint Fidelis leads manufactured by Medtronic. Leads are cardiac electrodes, or thin wires, that connect defibrillators directly to the heart. Evidence was mounting of complications such as multiple unnecessary shocks due to improper sensing, failure to deliver shocks when a patient was actually experiencing a life-threatening arrhythmia, dizziness, fainting, and heart palpitations, all associated with fractured leads – leads that were cracked or broken.
Some 268,000 heart patients worldwide, including 172,000 Americans, were in danger of losing their emergency rescue system, facing death or serious damage to their hearts.
If you or a family member had, or still have, an implanted defibrillator connected to a Medtronic Sprint Fidelis lead, here are some things you should know:
- This medical device recall did not include defibrillators themselves, or pacemakers or other Medtronic devices such as ICDs or CRT-Ds without a
Sprint Fidelis lead. However, a number of Medtronic pacemakers and defibrillators have been recalled over the past several years.
- Patients may have been implanted with a Medtronic Sprint Fidelis lead even if their defibrillator is manufactured by another company.
- Four Sprint Fidelis lead models were recalled: models 6930, 6931, 6948, and 6949. Physicians were asked to stop implanting them, and to return unused products to Medtronic. Patients should have identification cards that will include the model numbers for the leads attached to their defibrillators.
- The FDA says that removing faulty leads can be risky and may not be the best option, since the leads are threaded through the heart. Alternatives are to monitor the recalled models for signs of fracture, or to add a replacement lead surgically and “cap off” the Medtronic Sprint Fidelis lead in the patient’s chest.
You should consult your cardiologist or surgeon for advice about protecting your health if your defibrillator is connected with a recalled Sprint Fidelis lead. But if you or a loved one has suffered devastating consequences from this unsafe product, the attorneys at Searcy Denney have experience in lawsuits against Medtronic relating to defective leads and defibrillators. We are available to help you assess your potential claim and protect your rights. Please fill out our Contact Form, or call us to learn more and arrange for a confidential free consultation.