Sprint Fidelis Lawsuit Status | FDA News Lead Fractures
On September 4, 2008 the FDA released a News Alert regarding a software update from Medtronic that is supposed to help detect Sprint Fidelis lead fractures. Approximately 268,000 Sprint Fidelis lead have been implanted in patients worldwide. The Medtronic recall of heart leads included four Sprint Fidelis models: 6930, 6931, 6948 and 6949.
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FDA News
FOR IMMEDIATE RELEASE
September 4, 2008
FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures
The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company’s Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.
“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health, FDA. “While the software doesn’t fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”
Implantable defibrillators are used to treat patients at risk of experiencing life-threatening heart rhythm abnormalities. Should an abnormality occur, the defibrillator delivers a pulse of energy through a lead, a thin electronic wire, shocking the heart back into normal rhythm.
The Sprint Fidelis lead, the subject of an October 2007 Medtronic recall, was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all. Most of the patients with the Sprint Fidelis lead still have the device implanted because of the surgical risk associated with removal, and are being monitored by their health care providers for potential fracture.
Medtronic’s new software feature, called the Lead Integrity Alert, issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
Medtronic has agreed to actively monitor the performance of the new software feature in actual use, which will allow both the company and FDA to ensure that the device is protecting patients as intended.
If you or a loved one has questions regarding the Medtronic Sprint Fidelis lead recall please contact us and a Sprint Fidelis class action lawsuit attorney can help answer your questions. We offer a free consultation to individuals and families affected by the Medtronic recall.
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U.S. Food & Drug Administration Statement On Medtronic Sprint Fidelis Defibrillator
Medtronic Suspends Sprint Fidelis Defibrillation Leads (PDF)
U.S. FDA Class 1 Recall Report
If you or a loved one have been injured by the Medtronic Sprint Fidelis lead please contact us immediately. You may be entitled to compensation.
The Medtronic Sprint Fidelis 6949 is one of the manufacturer’s heart defibrillator leads that was subject to the Medtronic lead recall in 2007. These defective leads were also used in non-Medtronic heart defibrillators and pacemakers.
What is the function of defibrillator leads?
Defibrillators are implanted heart devices that shock abnormal heart rhythms back to a normal rhythm. [...]
Some people who have been harmed by defective Medtronic leads have filed lawsuits against the manufacturer. But, before filing a Medtronic lead lawsuit, there are several things that you should know.
Which product is defective?
Medtronic Sprint Fidelis defibrillator leads were more prone to fracturing than previous generation models of leads. Defibrillators are implanted heart devices that [...]
Medtronic manufactured a type of heart defibrillator lead that had defective wires. The defective wires were “leads,” which connected the defibrillator to the heart. The leads would fracture, or break, on numerous defibrillators. The Medtronic lead fracture was deadly in some patients.
Which defibrillators were defective?
The Medtronic lead fracture would occur in the Medtronic Sprint Fidelis [...]
Medtronic has been has been involved in litigation for defective Sprint Fidelis heart defibrillator leads. These Medtronics lawsuits were initiated because the “leads,” which are wires that connect the defibrillator device to the heart, could break, causing serious injury, and even death in some patients.
How many defective leads were produced?
More than 268,000 Medtronic Sprint Fidelis [...]
If you are seeking Medtronic lawsuit dismissed 2010 information and news about the recall related to your internal cardioverter defibrillator, we can provide the necessary background, facts and resources you need.
Medtronic Defibrillator
Medtronic is a manufacturer of a variety of medical products, notably of the Medtronic defibrillator. The internal cardioverter defibrillator is a small computer that [...]
