Medtronic Defibrillators
How many will be affected by these defective Medtronic defibrillators?
Medtronic has reported five patient deaths associated with fractured Sprint Fidelis Leads. The FDA has 599 reports of malfunctions and injuries associated with the Fidelis leads as of January, 2007. The reports of lead malfunctioning appear to be increasing at an accelerating rate, as the reports of problems have outdistanced the number of people who are receiving new Medtronic defibrillators, suggesting that the risks may increase over time. The FDA says that based on current information, fractures have occurred in less than 1 percent of Sprint Fidelis leads, but the FDA does not know if this rate of adverse events will remain constant or increase over the life of the Sprint Fidelis leads. The increasing number of reports and common sense tells us that this failure could result in tens of thousands of cases. Medtronic Corporation now estimates that about 2.3 percent of patients with the Sprint Fidelis lead or 4,000 to 5,000 people, will experience a lead fracture within 30 months of implantation of the device.
IF YOU WOULD LIKE MORE INFORMATION - CALL US DAY OR NIGHT AT 1-800-862-1260.
Did anyone realize that issues could occur with the Sprint Fidelis Leads?
When the Sprint Fidelis defibrillator leads were introduced, they did represent a technological advance, because the leads were 2.2 millimeters, almost half the size of what leads had historically been. This was considered an advance because doctors implanting defibrillators need to thread the lead wires through blood vessels, an easier task with a thin lead. The problem is that there was no history of safety. While there is still a lot of investigation that needs to be done by Medtronic lead recall lawyers, the early reports are that the FDA did not require clinical trial data on these leads. Which is unfortunate.
The reality is that there is millions of dollars at stake in the defibrillator business for medical device companies. The cost to bring these products to market is incredibly expensive but the profit margins are remarkably high. Accordingly, medical device manufacturers, like Medtronic, rush these products because of the huge profits available if you can either gain or maintain market share. In 2001, Medtronic's annual sales have more than doubled, to $12.3 billion, and earnings have almost tripled, going from $2.41 a share from 85 cents. For Medtronic, its goal was not only increased profit but chasing down Johnson and Johnson as the world leader in medical devices. For medical device lawyers, there is a feeling of dйjа vu to all of this. Virtually the same thing happened just a few years ago. In June 2005, Guidant, which has since been bought by Boston Scientific, recalled its defibrillators that it rushed onto the market. The Guidant Recall was arguably far less serious because at least a troubled defibrillator could be replaced. Lead wires are far more difficult to replace which makes this "recall" not much of a recall at all.
IF YOU WOULD LIKE MORE INFORMATION - CALL US DAY OR NIGHT AT 1-800-862-1260.
Medtronic has reported five patient deaths associated with fractured Sprint Fidelis Leads. The FDA has 599 reports of malfunctions and injuries associated with the Fidelis leads as of January, 2007. The reports of lead malfunctioning appear to be increasing at an accelerating rate, as the reports of problems have outdistanced the number of people who are receiving new Medtronic defibrillators, suggesting that the risks may increase over time. The FDA says that based on current information, fractures have occurred in less than 1 percent of Sprint Fidelis leads, but the FDA does not know if this rate of adverse events will remain constant or increase over the life of the Sprint Fidelis leads. The increasing number of reports and common sense tells us that this failure could result in tens of thousands of cases. Medtronic Corporation now estimates that about 2.3 percent of patients with the Sprint Fidelis lead or 4,000 to 5,000 people, will experience a lead fracture within 30 months of implantation of the device.
IF YOU WOULD LIKE MORE INFORMATION - CALL US DAY OR NIGHT AT 1-800-862-1260.
Did anyone realize that issues could occur with the Sprint Fidelis Leads?
When the Sprint Fidelis defibrillator leads were introduced, they did represent a technological advance, because the leads were 2.2 millimeters, almost half the size of what leads had historically been. This was considered an advance because doctors implanting defibrillators need to thread the lead wires through blood vessels, an easier task with a thin lead. The problem is that there was no history of safety. While there is still a lot of investigation that needs to be done by Medtronic lead recall lawyers, the early reports are that the FDA did not require clinical trial data on these leads. Which is unfortunate.
The reality is that there is millions of dollars at stake in the defibrillator business for medical device companies. The cost to bring these products to market is incredibly expensive but the profit margins are remarkably high. Accordingly, medical device manufacturers, like Medtronic, rush these products because of the huge profits available if you can either gain or maintain market share. In 2001, Medtronic's annual sales have more than doubled, to $12.3 billion, and earnings have almost tripled, going from $2.41 a share from 85 cents. For Medtronic, its goal was not only increased profit but chasing down Johnson and Johnson as the world leader in medical devices. For medical device lawyers, there is a feeling of dйjа vu to all of this. Virtually the same thing happened just a few years ago. In June 2005, Guidant, which has since been bought by Boston Scientific, recalled its defibrillators that it rushed onto the market. The Guidant Recall was arguably far less serious because at least a troubled defibrillator could be replaced. Lead wires are far more difficult to replace which makes this "recall" not much of a recall at all.
IF YOU WOULD LIKE MORE INFORMATION - CALL US DAY OR NIGHT AT 1-800-862-1260.
TRADEMARK NOTICE: Sprint Fidelis is a trademark of Medtronic Corporation.
The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Medtronic Corporation. The use of this mark is solely for informational and product identification purposes.
