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Medtronic Lawsuits: Defective Defibrillator Leads

Medtronic Sprint Fidelis defibrillator lead wires could fracture or break, resulting in unnecessary electrical shock or device failure .The lawyers at Saiontz & Kirk are no longer investigating Medtronic Lawsuits.  The information on this page is provided for information purposes only.

The lawyers at Saiontz & Kirk, P.A. are no longer revieweing potential Medtronic lawsuits nationwide for individuals who have a Sprint Fidelis defibrillator lead. The defective Medtronic wire, which is used to connect the defibrillator to the heart, could erode or break, causing serious and potentially fatal injuries.

Any individual who received a defibrillator since 2004 could have the recalled lead wire.  Approximately 268,000 Medtronic Sprint Fidelis leads have been implanted worldwide, with about 172,000 in the United States.

The Medtronic recall could impact anyone with the following model numbers indicated on their information card::

  • model 6930
  • model 6931
  • model 6948
  • model 6949

According to initial estimates, 4,000 to 5,000 people could experience problems with their lead within the first 30 months after the defibrillator is implanted. However, any individuals who have the defibrillator lead may be eligible for compensation.

If the lead wire fractures, a painful electrical shock could be delivered to the heart when it is not needed. The defect could also cause the battery to run out, preventing the defibrillator from working if it is needed to produce a life-saving charge.

MEDTRONIC LEAD PROBLEMS

Medtronic is a global medical product manufacturer which generates over $12 billion in annual sales. They are the largest seller of heart devices such as defibrillators and pacemakers. Their products account for over half of the $6 billion defibrillator market.

Defibrillators are small devices, about the size of a stop watch, which are implanted in the chest near the shoulder. A small lead or wire, runs from the device through the veins to the heart. They are designed to sense when the heart has begun beating too fast, and deliver a shock to propel the heart back into normal rhythm.

The Medtronic Sprint Fidelis lead is a newer electrical wire which was introduced in 2004. Defibrillator leads are very fragile, and the Fidelis lead is a thinner type of the wire which was designed for easier insertion. However, there have been reports of several deaths and major complications. A fracture or break in the wire, could cause the device to misread the heart rhythm data resulting in an unnecessary and potentially fatal electrical shock.

>>INFORMATION: Medtronic Sprint Fidelis Recall

Despite the risk of Medtronic lead problems, experts are not recommending that the wires be surgically removed. The risk of removing the lead from veins which carry it to the heart could be substantially more dangerous than leaving the potentially defective wire in place. Over time, scar tissue forms over the lead which increases the risk of a vein tear or damage to the heart muscle if it is removed.

MEDTRONIC DEFIBRILLATOR LAWYERS

This is not the first problem experienced by Medtronic in connection with their defibrillator systems. The Medtronic lawyers at Saiontz & Kirk, P.A. represented clients throughout the United States who were injured by defective Medtronic defibrillators which were previously recalled in 2005. Medtronic has also reported problems with other leads in the 1980s and again in 1991. At that time they indicated that some of their leads could gradually lose their ability to carry electricity.

The 2007 Spint Fidelis lead problem was identified following a review of 30 month performance data. A greater failure rate was associated with the Fidelis lead, when compared to an older Medtronic lead, the Sprint Quatro. At this time, it appears to have around a 2.3% failure rate, but that could increase in the future as more research and information is obtained.

MEDTRONIC CLASS ACTION SUITS

The lawyers at Saiontz & Kirk, P.A. are no longer reviewing potential class action suits as well as individual Medtronic lawsuits for anyone who had the defective defibrillator lead implanted.

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