Medtronic Lawsuit

If you have reason to believe that a young child has received a Medtronic pacemaker with Sprint Fidelis leads, you should have the child’s parents contact their physician and/or the hospital immediately to make that determination.  Please note that only the Sprint Fidelis leads have been recalled – not the pacemaker itself.  Although most physicians are not recommending removal of the leads (due to the extreme risk associated with that procedure), the physician may be able to make adjustments to increase the likelihood that a lead failure will be recognized before the patient is harmed.

On October 15, 2007, Medtronic suspended sales and recalled all unused Sprint Fidelis Leads after receiving reports of at least five fatalities linked to lead fractures.  Unfortunately, prior to the recall, the defective Medtronic Sprint Fidelis Defibrillator leads were implanted into hundreds of thousands of people, leaving all of them at risk for serious injury if a Sprint Fidelis Lead fractures.  Those patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to have the wire replaced.

According to a recent article in The Wall Street Journal, since being introduced in 2004, Sprint Fidelis leads have been implanted in approximately 268,000 patients.  Of those, 2,085 were in people under 21.  The Sprint Fidelis lead was considered a good choice for children because the thinness of the component made the wire easier to thread into tiny blood vessels.  But because children and young people are more active and their hearts beat faster than adults, defibrillator leads are more likely to fail in younger patients.  Metronic estimates that approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a Medtronic defibrillator implanted.  That risk increases to 3.8% for patients under 21.

However, some reports indicate that Medtronic’s reported failure rates are significantly under-estimated.  At least two independent studies cited by The Wall Street Journal show much higher rates of Sprint Fidelis fracture rates.  Data compiled by a researcher at Northwestern University’s Feinberg School of Medicine found that, over 30 months, the fracture rate in 569 patients with the defective leads was a staggering 6.7%.  A second survey by the same researcher found that of 304 patients implanted with a particular Sprint Fidelis model, the fracture rate stood at 4.9%.

Even with the recall and the potential serious risks, the Food & Drug Administration (FDA) is not recommending removal of the Sprint Fidelis leads.  Most doctors seem to agree and are recommending that the unfractured leads not be replaced at this time.  The procedure to remove and replace the leads is extremely invasive and dangerous.  Replacing a lead is much riskier than replacing the defibrillator itself.  There is no test to determine whether or not a particular lead will fail.  Instead, Medtronic suggests that the physician re-program the pacemaker to increase the likelihood that a lead failure will be detected before the patient is harmed.

It’s important to acknowledge that the FDA is unable to carefully test and screen all such devices or surgical tools.  In recent years, the approval process for medical devices has been accelerated as manufacturers motivated by the desire for profit have pushed harder and harder for faster approval and less rigorous testing. Oftentimes, the FDA simply approves a new device, prosthesis, or implant on the basis that it is “substantially similar” to a device already on the market.  Each year, a number of defective or poorly designed medical devices cause deaths and severe injuries. Some of these devices are immediately recalled, while others are allowed to linger on the market.

Medtronic received approval from the FDA for its “state of the art” Spring Fidelis defibrillator leads on September 2, 2004.  Since that time, Sprint Fidelis leads have been implanted in approximately 268,000 patients.  Medtronic has been receiving reports of Sprint Fidelis lead fractures for months, yet only decided to suspend sales of the components on October 15, 2007.  Considering the injuries that can result from a lead fracture, and the dangerous operation patients must undergo to have a lead replaced, many patient advocates are shocked that Medtronic allowed the defective Sprint Fidelis leads to stay on the market for so long.

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.  In February 2007, the Minneapolis Heart Institute published a study of lead failures in the Sprint Fidelis models compared to the Sprint Quattro models, another type of Medtronic lead.  The researchers in Minneapolis found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro.  As a result, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis lead was “significantly less reliable” than its predecessor.

In March 2007, Medtronic sent a letter to doctors warning them of the lead’s possible problems; however, the company maintained that the fractures were partly the result of the leads not being properly implanted.

To learn more, please contract the Medtronic Lawyers at Williams Kherkher by calling 1.800.220.9341.