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Medtronic Recall: Sprint Fidelis Defibrillator Lead

A Medtronic defibrillator lead recall was issued because the small wires could fracture or break, resulting in electrical shock or device failure. The lawyers at Saiontz & Kirk are no longer investigating Medtronic Recall Lawsuits.  The information on this page is provided for information purposes only.

On October 15, 2007, the FDA announced a nationwide Medtronic recall for the Sprint Fidelis defibrillator lead, which is an electrical wire that connects a defibrillator to the heart. The defective lead is prone to fracturing or breaking, which could result in a massive electrical shock or cause the defibrillator to not work when it is needed.

The FDA classified the Sprint Fidelis recall as a “class 1″ recall since the defect has a substantial likelihood to cause serious injury or death. Any defibrillators implanted since 2004 could have one of the leads. The Medtronic recall applies to the following models:

  • Sprint Fidelis model 6930
  • Sprint Fidelis model 6931
  • Sprint Fidelis model 6948
  • Sprint Fidelis model 6949

MEDTRONIC LEAD RECALL

The Sprint Fidelis lead was introduced by Medtronic in 2004. It was developed in a rush to compete with other cardiac device companies by having a more compact and flexible product. It replaces their thicker lead, known as the Sprint Quattro, which was introduced in 2001.

Metronic has received reports of individuals experiencing severe electrical shocks as a result of their defibrillator firing when it was not needed, and at least five deaths could have been caused by the faulty lead wire. A recall was issued following a review of data from a clinical trial involving 650 individuals at 17 hospitals, and a review of pooled data for 25,000 patients collected from CareLink, a system Medtronic has for monitoring implants.

Approximately 268,000 of the recalled Medtronic leads are already implanted in patients. According to industry analysts, the Sprint Fidelis lead is used on about 60% of all Medtronic defibrillators implanted, but it could also be used with other defibrillators manufactured by companies like Boston Scientific/Guidant or St. Jude. It is not used with pacemakers.

MEDTRONIC DEFIBRILLATOR LEAD MALFUNCTIONS

Three different defibrillator malfunctions could occur as a result of the Medtronic Sprint Fidelis lead:

  1. The defibrillator could beep, alerting that there is a problem requiring immediate medical attention
  2. A massive electrical shock could be delivered to the heart, which could be lethal in some cases
  3. The battery could deplete, causing the device to fail when it is needed to provide a life-saving shock

There is no consistently reliable test to predict whether the Medtronic lead will fracture in the future. However, despite the risk of malfunctions, experts are not recommending that the recalled Medtronic lead be surgically removed. Surgery to remove the wire or attepts to place a second lead in the chest carries a substantial risks, as it is a much more complex procedure than the initial insertion.

The only recommendation that Medtronic has made to reduce the impact of their mistake, is that those who think they may have the Sprint Fidelis lead should contact their doctors who could reprogram the defibrillator to better monitor for lead problems. This should increase the likelihood that a fracture will be detected by the device before any harm is caused by an unnecessary shock.

This provides little reassurance to most individuals who have the defective Metronic lead placed in their chest. Even if a fracture is detected before the device malfunctions, they will still face the serious risks associated with implanting a second lead wire or replacing the current lead, which has an alarmingly high rate of complications.

MEDTRONIC RECALL LAWSUITS

The attorneys at Saiontz & Kirk, P.A. pursued compensation for individuals who have the Sprint Fidelis lead. As a result of the defective wire which was placed in their chest, Medtronic has forced them to face a future of concern about whether their device will suddenly malfunction.

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