Defective lead recall
On October 15, 2007, Medtronic suspended sale of their Sprint Fidelis Defibrillator leads (Models 6930, 6931, 6948, 6949) after receiving reports of 5 fatalities. I am glad to report that Metronic finally took the appropriate action by suspending global sales of the defective leads and recalling the leads already on the market. Unfortunately, however, this defective lead recall came too late for five innocent people that trusted Medtronic with their lives.

Faulty design
The Medtronic recall is for defective defibrillator leads which are designed to carry a live-saving signal from an implanted device to the heart, in the event that a dangerous heart rhythm is detected.

The problem here is that if the lead wires from the defibrillator to the heart are broken or fractured, the defibrillator may erroneously detect an abnormal heart rhythm, causing it to send an unnecessary, painful jolt of electricity to the heart. Or even worse, if a life-saving shock is needed, it may never reach the heart.

Evidently, that is exactly what happened to at least five patients who are reported to have died as the result of a defective lead wire.

The dilemma for patients
According to Medtronic, over 268,000 patients in the United States have been implanted with the defective lead (as part of the defibrillator) since 2004. And of those 280,000, as many as 5,000 - 10,000 patients could see their leads fail within 30 months of being implanted.

Medtronic has offered to pay for the replacement of fractured leads and to contribute $800 towards the replacement surgery, however, they will not compensate patients who wish to replace a “working” lead. So, the great dilemma facing patients and doctors is whether or not to roll the dice with a lead that currently works, but could fail at any time.

The other option would be to shell out thousands of dollars in out-of-pocket expense to replace the recalled lead. This option has the potential to damage the fragile blood vessel that the lead runs through.

A third option would be to leave the defective lead in place and run a new lead along side it.

Each of these options has inherent risks which need to be considered when discussing a course of action with one’s doctor.

The legal option
Beasley Allen law firm is currently reviewing cases against Medtronic, the manufacturers of the Sprint Fidelis defibrillator.

If you or a loved one have been injured by a defective heart lead, you may have a claim against the manufacturer of the Sprint Fidelis defibrillator.

You may contact Beasley Allen Law firm for a free legal consultation by filling out a brief questionnaire, or by calling their toll free number (1-800-898-2034).

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