Medtronic and the Food and Drug Administration (FDA) have issued statements that Medtronic is voluntarily removing its Sprint Fidelis defibrillation leads from the market as the electrical wires are "prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all."
A defibrillator is an electrical device used to counteract fibrillation of the heart muscle and restore normal heartbeat by applying a brief electric shock. They should not be confused with pacemakers that regulate the heart to ensure a continuous beat. Medtronic has said that none of its pacemakers use the possibly dangerous leads.
Medtronic's Sprint Fidelis model has already been linked to five deaths and major complications after the leads have fractured. The company, which estimates that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. According to reports, the company already faces more than 900 lawsuits over defibrillators, some of which stopped working without any warning whatsoever.
Medtronic is warning doctors and patients about the potential complications and is voluntarily suspending distribution of the product because a small number of fractures have been detected. Medtronic knew about the problem in March of 2007 and issued some warnings, but not to this extent as it did not think that the statistical data required it. However, additional data since that time has shown that the defibrillators could be deadly. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured.
Consumer information
According to the company, any remaining products should be pulled from inventory and returned to the company. Patients who have been implanted with this lead are encouraged to contact their physicians for further information. Physicians are being advised to 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.
The FDA is considering this a 'recall', but is not necessarily recommending that the devices be surgically removed - just that no new leads can be implanted in patients. The FDA has also said that there is no test available to predict if a lead will fracture.
Medtronic has issued statements that it will cover the cost of a replacement lead for those that have fractured, plus up to $800 in medical expenses that are not covered by insurance. However, the company has also stated that it will not pay for procedures to replace functioning leads that patients want taken out to head off possible problems in the future.
Medtronic and the Food and Drug Administration (FDA) have issued statements that Medtronic is voluntarily removing its Sprint Fidelis defibrillation leads from the market as the electrical wires are "prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all."
A defibrillator is an electrical device used to counteract fibrillation of the heart muscle and restore normal heartbeat by applying a brief electric shock. They should not be confused with pacemakers that regulate the heart to ensure a continuous beat. Medtronic has said that none of its pacemakers use the possibly dangerous leads.
Medtronic's Sprint Fidelis model has already been linked to five deaths and major complications after the leads have fractured. The company, which estimates that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. According to reports, the company already faces more than 900 lawsuits over defibrillators, some of which stopped working without any warning whatsoever.
Medtronic is warning doctors and patients about the potential complications and is voluntarily suspending distribution of the product because a small number of fractures have been detected. Medtronic knew about the problem in March of 2007 and issued some warnings, but not to this extent as it did not think that the statistical data required it. However, additional data since that time has shown that the defibrillators could be deadly. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured.
