Sprint Fidelis

Sprint Fidelis

On October 15, 2007, Medtronic Inc., manufacturer of pacemakers and other implantable heart devices, suspended sales of its Sprint Fidelis lead, an important component of the company’s implantable defibrillators. Data showed that Medtronic estimated that about 2.3 percent of heart patients, or as many as 4,000 to 5,000 people with an implanted Sprint Fidelis lead attached to their Medtronic defibrillator, will experience lead fracture within 30 months of having the device implanted.

On November 26, 2007, a Bismarck woman, Winnifred Leverson, filed a lawsuit against Medtronic. Although Leverson’s defibrillator is not broken and is working properly, her lawsuit alleges that she suffered emotional distress and negligence. The lawsuit seeks restitution and medical monitoring.

The Sprint Fidelis was introduced in 2004 and was set to replace a previous model, Sprint Quattro, in its line of implantable defibrillator. In Sprint Fidelis, a lead wire connects an implantable defibrillator to the heart and provides an electrical shock if it senses an out of sync heart rhythm.

Medtronic’s Sprint Fidelis lead wires have been shown to have a fracturing problem. Medtronic and the U.S. Food and Drug Administration approximate the risk of breakage to be fewer than one percent. However, if the Sprint Fidelis lead wires do fail, devastating and sometimes fatal adverse events could follow. The fracture defect could cause the defibrillators to deliver a massive and painful electrical shock. The fracture defect could also cause the device to fail to administer lifesaving shocks to people at risk of cardiac arrest.

In an article written by doctors at one of the premier heart institutes in the world, The Minneapolis Heart Institute, researches found that Sprint Fidelis lead had a higher chance of fracturing as compared to Medtronic’s older model, Sprint Quattro. According to Medtronic’s own data, approximately 2.3% or 4,000 to 5,000 people will experience a Sprint Fidelis lead fracture within 30 months of lead wires implantation.

In recent articles, the recalled Sprint Fidelis lead has also been found to provide poor sensing capabilities. The increasingly poor performance of the lead is a concern to clinicians as it, much like the lead wire fractures, may exert inappropriate shocks. Although this is a new discovery in addition to the other defects the Sprint Fidelis lead have been experiencing in 2007, it is a concern that could be seen published in medical journals.

Source: Elizabeth Trotta, “More Faults in Halted Medtronic Device?”, November 26, 2007; “Bismarck woman sues Medtronic over recalled defibrillator wires”, Examiner, November 27, 2007; “Woman Sues Over Recalled Heart Devices”, KFYR-TV, November 27, 2007; RG Hauser et. al. “Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead“, PubMed, July 2007;“Medtronic Sprint Fidelis Defibrillator Lead Could Have Sensing Capability Problems“, News Inferno, November 27, 2007; U.S. Food and Drug Administration, “Medtronic Recalls Sprint Fidelis Cardiac Leads Questions and Answers for Consumers“, October 15, 2007.

Medtronic Faces Sprint Fidelis Lead Lawsuit

Heart Patients Seek Class Action Lawsuit Status

On October 22, 2007, Leonard Stavish and Kelly Luisi filed a product liability lawsuit against Medtronic Inc., manufacturer of pacemakers and other various heart devices, over a recall of the company’s fractured heart defibrillator wires. They are seeking class action status to represent others like themselves who may suffer serious personal injury as a result of a product defect.

Stavish’s personal injury attorneys claim his heart defibrillator was removed after Stavish received 47 jolts he did not need. He was given another defibrillator with a new set of Sprint Fidelis leads.

According to the lawsuit, Luisi experienced “frightening episodes of unnecessary shocks,” and went to the emergency room. At the hospital, someone from Medtronic used an instrument to check Luisi’s device, after which the device “began delivering unnecessary shocks over and over again,” according to the lawsuit. The lead to her heart defibrillator was later removed.

Removal of heart defibrillator leads can be dangerous because the process may tear at fragile blood vessels and tissue. According to her Sprint Fidelis lawsuit, Luisi was forced undergo surgery to remove the Sprint Fidelis lead, “scarring her already fragile heart, and forcing her to undergo additional and unnecessary complicated surgery.”

A lawyer for Stavish and Luisi said he has 25 more clients who will sue when their written complaints are completed.

Source: “Hearts patients sue Medtronic over device,” KansasCity.Com, October 22, 2007.

Medtronic Sprint Fidelis Recall

2.3% of patients may experience potentially life-threatening malfunctions

On October 15, 2007, Medtronic Inc., manufacturer of pacemakers and other implantable heart devices, suspended sales of its Sprint Fidelis lead, an important component of the company’s implantable defibrillators. Data showed that Medtronic estimated that about 2.3 percent of heart patients, or as many as 4,000 to 5,000 people with an implanted Sprint Fidelis lead attached to their Medtronic defibrillator, will experience lead fracture within 30 months of having the device implanted.

FIDELIS LEAD FRACTURE COULD RESULT IN MASSIVE ELECTRICAL SHOCKS

Defibrillators rely on a complex set of wires which connect the devices to the heart muscles. The wires sense abnormal heart rhythms, alerting the device to deliver an electrical pulse to the heart to prevent heart failure.

According to the Medtronic recall notice, the wire that connects the Medtronic defibrillator to the heart, called the Sprint Fidelis lead, could fracture inside a patient’s blood vessel. This lead fracture could cause a defibrillator to malfunction and deliver massive electrical jolts that could cause extreme pain or death.

Source: Thomas M. Burton and Anna Wilde Mathews, “Medtronic Recall Exposes Gaps in Medical Safety,” Wall Street Journal, October 30, 2007.

5 deaths linked to Sprint Fidelis Lead

As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide, including 172,000 Sprint Fidelis leads implanted in the United States. There have been at least five deaths and a number of other serious injuries reported in which a Sprint Fidelis Lead fracture may have been a contributing factor. Did Medtronic know about the risks associated with implanting Sprint Fidelis? Did Medtronic fail to warn patients of the dangers inherent in its product?

Sources: “Medtronic Voluntarily Suspends Distribution of Sprint Fidelis® Defibrillation Leads,” Medtronic.com, October 15, 2007; “Medtronic Defibrillator Sprint Fidelis Lead Recall Sparks Congressional Investigation,” News Inferno, October 23, 2007.

Sprint Fidelis: Who’s to blame?

Medtronic’s recall of the Sprint Fidelis defibrillator lead has led to product liability lawsuits and investigation into both the company and the U.S. Food and Drug Administration’s (FDA) actions. An investigation by the Wall Street Journal found that both Medtronic and the FDA were aware of potential defects in the Sprint Fidelis Lead as early as seven months before Medtronic’s recall action.

Daniel Schultz, director of the FDA’s device center, told the Journal that the FDA “had pieces of information that suggested there were certain problems associated with the Fidelis lead.” However, “there was nothing we could point to specifically to say this is a violative product that needs to come off the market.”

This type of failure to recognize safety issues has become so commonplace in the FDA’s medical device regulation arm that cardiologist Robert G. Hauser, a senior consulting cardiologist at the Heart Institute in Minneapolis, organized the creation of a private, multihospital database of failure reports in defibrillators, pacemakers and leads for cardiologists’ use. Dr. Hauser’s database was instrumental in triggering the massive recall of Guidant Corporation defibrillators in 2005 after a pattern of failure was detected by cardiologists.

Source: Thomas M. Burton and Anna Wilde Mathews, “Medtronic Recall Exposes Gaps in Medical Safety,” Wall Street Journal, October 30, 2007.

Cardiologists stop using the Fidelis Lead

In January 2007, Dr. Hauser consulted two doctors at the Heart Institute after two patients came in to the clinic on two consecutive days complaining that their heart defibrillators had jolted them with “huge, unnecessary and painful electric shocks.” One patient, a 65-year-old woman, was shocked 14 times in an hour. The doctors found the two patients both had Sprint Fidelis Leads which had fractured, and they had found four other cases of Fidelis lead fractures in the clinic over the past seven months.

Dr. Hauser searched his multihospital database and found similar fracture trends. He also found multiple Sprint Fidelis Lead fractures in a separate federal database. Dr. Hauser contacted Medtronic, and in February he and other clinic doctors met with a vice president and engineer from the company. Dr. Hauser argued that the cases pointed to a serious problem with the devices.

Medtronic disagreed with the Heart Institute’s physicians, suggesting that the lead fractures may have resulted from the doctors’ misuse of the devices. While Medtronic continued to stick by its own failure data, the Heart Institute, as well as several other hospitals with access to Dr. Hauser’s information, stopped using the Sprint Fidelis Lead during implant procedures.

Source: Thomas M. Burton and Anna Wilde Mathews, “Medtronic Recall Exposes Gaps in Medical Safety,” Wall Street Journal, October 30, 2007.

Options Limited for Patients with Sprint Fidelis Lead

Patients with implanted Sprint Fidelis leads have very few options. The risk of removing the defibrillator lead is high; it is not recommended that patients remove the device due to the risks inherent in invasive, open heart surgery.

Replacing a heart defibrillator lead is not an easy procedure. It requires invasive surgery that can cause the tissue of the blood vessels and heart to tear. There are only two other alternatives available. The first alternative is to continue use of the lead and monitor it closely for signs of fracture. The second alternative is to surgically add a replacement lead. The original Sprint Fidelis lead can remain inside the patient without being used. This option requires the tip of the lead to be “capped,” or covered with small plastic insulation.

Sources: “Medtronic Defibrillator Sprint Fidelis Lead Recall Sparks Congressional Investigation,” News Inferno, October 23, 2007; U.S. Food and Drug Administration, “Medtronic Recalls Sprint Fidelis Cardiac Leads Questions and Answers for Consumers“, October 15, 2007.

Hire a Medtronic Sprint Fidelis Lawyer Today – Free Call, No Obligation

If you or someone you love has a Medtronic Sprint Fidelis Lead implanted, it may be in your best interest to contact a product liability lawyer. Contact our personal injury law firm today.

If you have suffered shocks, pain or other suffering due to your implanted Sprint Fidelis lead, you may be entitled to compensation for the injuries or additional surgical procedures you may have suffered as a result. Our legal team is investigating the circumstances of this case. Your information will be reviewed by a lawyer who may be able to help you gain compensation from a Sprint Fidelis Lead lawsuit.