Research shows that Medtronic Sprint Fidelis defibrillator leads are more likely to fail after the defibrillator’s generator is exchanged. Due to fractures in the leads, the U.S. Food and Drug Administration (FDA) announced that Medtronic recalled them in October 2007.
What Are Medtronic Sprint Fidelis Defibrillator Leads?
Defibrillator leads are used in “implantable cardioverter defibrillator” (ICD) and “cardiac resynchronization therapy defibrillator” (CRT-D) device implantation procedures. The leads connect the heart to the defibrillator and monitor and regulate the recipient’s heart rhythms by controlling the voltage the defibrillator delivers. They are insulated to ensure electrical pulses from the defibrillator reach the heart muscle. By June 2012, 268,000 leads had been implanted in people worldwide, but only 100,000 remained in patients’ bodies.
Medtronic Sprint Fidelis Defibrillator Leads Might Cause Life-Threatening Side Effects
In October 2007, the FDA announced a Medtronic Sprint Fidelis defibrillator lead recall, classifying it as a Class I recall, the most serious kind because the device posed a risk of causing serious injury or death to recipients. The recall occurred because the leads were fracturing inside patients’ bodies. When this happens, the following side effects can result:
- Abnormal sensing or pacing of the heart rhythm
- Delivery of inappropriate shocks to the heart
- Non-delivery of needed shocks to the heart
All three of these effects can be life-threatening because they can culminate in cardiac arrest. The recall applies to all leads manufactured between September 2004 and October 15, 2007.
Subsequent research on Sprint Fidelis leads in the medical journal Heart Rhythm showed that they failed more frequently than any other type of lead at a rate of 3.75 percent per year versus 0.58 percent per year. The failure rate also grew more quickly over time for Sprint Fidelis leads than all other types. In March 2009, Medtronic informed doctors that defective leads contributed to 13 out of 107 deaths of people who had been implanted with them. Research published in Heart Rhythm in 2012 also found that exchanging the defibrillator’s generator increased the risk of lead failure, leading to a 20.8 percent failure rate as opposed to a 2.54 percent rate for those whose generators had not been replaced.
Plaintiffs implanted with Sprint Fidelis defibrillator leads have faced challenges obtaining compensation in court. In January 2009, a federal multidistrict litigation (MDL) case was dismissed from Minnesota federal court because a 2008 U.S. Supreme Court decision, Riegel v. Medtronic, held that federal law preempted the plaintiffs’ state court claims in MDL. The Eighth Circuit Court of Appeals upheld that ruling in 2010. A Minnesota state court judge dismissed a similar case against Medtronic for the same reasons in October 2009. A group of plaintiffs filed a lawsuit against Medtronic in December 2012, and they allege the device-maker dumped thousands of defibrillators on the market knowing they would fail and bribed doctors to implant them anyway.
RLG’s Medtronic Sprint Fidelis Defibrillator Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Sprint Fidelis defibrillator leads lawsuit on your behalf if necessary. RLG will also keep you up to date on any Sprint Fidelis defibrillator leads class action lawsuits, FDA Sprint Fidelis defibrillator leads warnings, and additional Sprint Fidelis defibrillator leads FDA recall announcements. If you or a loved one received Sprint Fidelis defibrillator leads and believe they caused an injury, contact RLG today.