Medtronic Updates Doctors on Reports of Sprint Fidelis Lead Deaths

According to a letter sent to doctors on Friday by Medtronic, Inc., at least 107 deaths have been reportedly linked to their recalled Sprint Fidelis defibrillator leads. However, Medtronic only acknowledges that the defective leads were a “possible or likely contributing factor” in 13 of the cases.

The Medtronic Sprint Fidelis lead is a small electrical wires that was used to connect cardiac defibrillators to the heart between 2004 and 2007.

In October 2007, a Medtronic recall was issued for the Sprint Fidelis leads due to an increased risk that the wire may fracture or break, which could result in unnecessary shocks or cause the defibrillator not to work if it is needed to deliver a life-saving jolt.

About 268,000 people worldwide had the defective leads implanted in their bodies, and Medtronic acknowledged at the time of the recall that at least 5 deaths had been caused by their product.

On March 13, 2009, Medtronic provided their first update for doctors about the number of Sprint Fidelis deaths that have been reported and confirmed.

According to the letter, the FDA has received reports of 107 deaths which were allegedly caused by faulty lead wires. However, Medtronic indicates that most of the reports were made directly by patients or their product liability lawyers, without substantial supporting data.

Medtronic convened a panel of physicians who reviewed 89 of the Sprint Fidelis death reports, and they only identified the defective defibrillator leads as a possible or likely factor in 13 of the fatalities.

The panel did note that over 30% of the deaths (4 out of 13) occurred in patients who were having the Sprint Fidelis leads removed from the veins which carry the small wire from the defibrillator to the heart.

This highlights the difficult position patients are placed in if their lead does fracture, as scar tissue often forms around the lead wire, making it very risky to remove the lead or attempt to thread a new lead through the vein.

Last month, an independent study published by the medical journal Heart Rhythm, found that the Sprint Fidelis leads are only continuing to work in about 88% of patients reviewed at three years. The researchers also suggested that the risk of a lead fracture is higher than originally thought and is continuing to increase as time passes.

About 2,000 Medtronic defibrillator lead lawsuits have been filed by patients who had the Sprint Fidelis lead implanted.

In January 2009, U.S. District Judge Richard H. Kyle, who has been assigned to oversee pretrial litigation in all of the federal cases, indicated that the Sprint Fidelis lawsuits will be dismissed based on a recent Supreme Court decision that found medical device product liability claims are pre-empted by federal law if the device was approved by the FDA.

Earlier this month, the Medical Device Safety Act of 2009 was introduced in the U.S. Senate and U.S. House to reverse the Supreme Court interpretation of federal law. If passed, the legislation would protect consumers ability to pursue product liability lawsuits, and likely restore patients’ ability to hold Medtronic responsible for injuries caused by their defective defibrillator leads.