Medtronic now faces lawsuits from patients who have a Sprint Fidelis lead attached to their heart and defibrillator. Medtronic lead lawsuits are now being filed in many states, and attorneys familiar with this medtronic recall are providing counsel to these patients. The FDA considers this to be a medical device recall and has put a warning out to patients.
In a statement released to the public, Medtronic advises that a voluntary marketing suspension Sprint Fidelis Defibrillator Leads has taken place.
Medtronic decided to voluntarily remove its Sprint Fidelis defibrillation leads from the market. According to adverse event reports, the electronic wires are prone to fracture and can cause the defibrillator to deliver unnecessary shocks or not operate at all. These failures have resulted in deaths and major complications.
Patient Fear of Defect in Device
While defibrillators are life-saving products, it is scary for a patient who needs the device to monitor and correct heart rhythm abnormalities to know that there is a defect in that device that could cause serious injury. Medtronic has admitted that it is "frightening for a patient to learn that a product they rely on so much might have a serious defect."
Since the Sprint Fidelis defibrillation leads fractures have been detected, no more of these defective leads will be sold or manufactured and Medtronic is advising that any remaining product should be pulled from inventory and returned to the company.
Why has this taken so long?
Medtronic first notified physicians in March 2007 that there were failures. Why only now are patients with these implanted leads being asked to contact their physicians for further information? We intend to get an answer to that question for our clients!
What went wrong?
Most implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) function fine. They are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds put the heart back into normal rhythm by delivering a pulse of energy (electric shock) through an electrode wire or lead that is connected to the heart.
Some of these wires have been found to have broken. Luckily, not every wire breaks. In fact, according to Medtronic, most leads function well. But, where a lead actually breaks, or "fractures," the lead may send false signals. These signals can result in too many or too few shocks.
The FDA now considers this problem to be a product recall, which means that Medtronic will soon be issuing a recall classification for this action. Medtronic points out that the word "recall" does not mean that the devices must be surgically removed and returned to the manufacturer. However, the company points out in its publications that going forward these "leads should no longer be implanted in patients."
Will my wires fracture? Is there a test?
Medtronic has advised that there is no test to predict which leads will fracture.
Should you have the wire removed?
Medtronic does not currently recommend the routine surgical removal of a fractured lead because removal carries risks. You need to discuss this with your doctor. Your physicians can help you weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.
What if you have a defibrillator from another company?
A number of Sprint Fidelis leads are used with defibrillators made by non-Medtronic manufacturers. If you think that you have a Sprint Fidelis lead or if you do not know the model of your lead, you can contact your doctor to obtain this information.
If you or someone you know has received a defibrillator with Sprint Fidelis leads (implants since 2004), please contact our offices for a free case evaluation.