Sprint Fidelis Implantable Cardiac Lead Device - Recalled MODELS 6930, 6931, 6948, 6949
Have you suffered from unnecessary shocks from your defibrillator? If so, your defibrillator may have defective cardiac leads. It is advised that you see your physician as soon as possible. If your leads are recommended for removal or replacement you may be entitled to compensation by the manufacturer. Contact us at no charge to learn your legal options.
Our firm is investigating claims and numerous adverse event reports made to the FDA arising from failures of the Sprint Fidelis Implantable Cardiac Lead, a medical device manufactured by Medtronic, Inc., and its subsidiary, Medtronic Puerto Rico, Inc, These devices are the wires that connect implantable cardiac defibrillators and resynchronization devices to the heart. The Sprint Fidelis Lead may have been used to connect devices manufactured by other companies such as Guidant, Boston Scientific, and St. Jude, as well as Medtronic's own devices. If you have been advised that your ICD lead must be replaced check your device identification card to determine if it is a Medtronic Sprint Fidelis Lead. If so, you may contact us at no charge to discuss your situation.
A Lead is part of a implantable heart defibrillation system that has three main parts: the defibrillator, leads, and a programmer. Two parts of this system are placed inside the body.
RECALLED MODELS
Sprint Fidelis® MODEL 6930
Sprint Fidelis® MODEL 6931
Sprint Fidelis® MODEL 6948
Sprint Fidelis® MODEL 6949Our firm is investigating claims and numerous adverse event reports made to the FDA arising from failures of the Sprint Fidelis Implantable Cardiac Lead, a medical device manufactured by Medtronic, Inc., and its subsidiary, Medtronic Puerto Rico, Inc, These devices are the wires that connect implantable cardiac defibrillators and resynchronization devices to the heart. The Sprint Fidelis Lead may have been used to connect devices manufactured by other companies such as Guidant, Boston Scientific, and St. Jude, as well as Medtronic's own devices. If you have been advised that your ICD lead must be replaced check your device identification card to determine if it is a Medtronic Sprint Fidelis Lead. If so, you may contact us at no charge to discuss your situation.
A Lead is part of a implantable heart defibrillation system that has three main parts: the defibrillator, leads, and a programmer. Two parts of this system are placed inside the body.
- The defibrillator is small metal case that contains electronics and a battery. It is similar to a pacemaker in that it is designed to correct arrhythmias. But while a pacemaker increases a slow heart rate, a defibrillator detects and corrects fast and slow heart rates.
- Leads are specialized, thin, insulated wires that are attached to the defibrillator. Leads sense the heart's rhythm and deliver therapy to the heart (as directed by the defibrillator).
The third part, the programmer, is kept in a hospital or clinic. A doctor or nurse uses this specialized computer to monitor and change the instructions of the implanted defibrillator.
If any part of the system fails to function as indicated, a patient is at great risk for serious injury. We have been contacted by individuals whose leads have failed prematurely, leading to replacement. We have also seen a recent rise in reports to the FDA of similar failures.
If you believe that you, your family or friends have been injured by the Sprint Fidelis Lead, please contact Neblett, Beard & Arsenault at 1-800-256-1050 or contact us to learn more about the legal options available to you or your loved ones -- FREE of charge.
St. Jude Lead May Punch Hole in Heart, Journal Says - to read click here.
St. Jude Defends ICD Lead Wires - to read click here.
Class Action Suit Filed on Behalf of Patients Injured by Leads
We are proud that we filed suit yesterday on behalf of patients implanted with the Medtronic Sprint Fidelis. We filed suit in Minneapolis, Minnesota as well as San Juan, Puerto Rico, where the leads were manufactured. Here is some information in the press about the suit filed in Minneapolis.
Medtronic Inc. Ignored Sprint Fidelis Lead Problems for Months
Medtronic Inc. is facing serious questions about its handling of problems with its defective Sprint Fidelis leads, a component of implantable defibrillators. Medtronic had been receiving reports of Sprint Fidelis lead fractures for months, yet only decided to suspend sales of the components this week.
Defective Medtronic Defibrillator Lead Problems Known for Months, Yet FDA Did Nothing
Reports of frequent fracturing of Sprint Fidelis leads on Medtronic implantable defibrillators had been piling up for months, but the company only chose to withdraw the defective leads earlier this week. According to new reports, by January 2007, the Food & Drug Administration (FDA) knew of hundreds of cases where the Sprint Fidelis lead fractured and caused serious injuries in people with Medtronic implantable defibrillators, yet neither the agency nor Medtronic took any action at that time.
FDA Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads
Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.
Medtronic Finally 'Warns' of Defects with Sprint Fidelis Leads
For the last several months, we have been watching this unfortunate situation unfold. We currently represent plaintiffs who have experienced shocks due to faulty leads in their defibrillators. Some have been shocked more than 40 times due to the defective leads! This “warning” by Medtronic is long past due. This is what this morning’s New York Times said about Medtronic’s announcement to warn patients who have the Sprint Fidelis lead implanted in them and to recall non-implanted leads.
Patients Warned as Maker Halts Sale of Heart Implant Part
The nation’s largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component in its most recent defibrillator models because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths.
Medtronic Recall Exposes Gaps in Medical Safety
In late January, something unsettling happened at the Minneapolis Heart Institute. On two successive days, patients came to the clinic after their heart defibrillators had jolted them with huge, unnecessary and painful electric shocks. One 65-year-old woman said she'd been zapped 14 times in an hour.