Monday, October 15, 2007

Medtronic Defibrillator Wire Attorney

The largest player in the implantable heart defibrillator market announced yesterday that it is halting sales of the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, after it was determined the leads could be potentially defective.

Medtronic is also urging doctors to stop using the Fidelis lead after hundreds of incidence reports pointing to potential malfunctions. The product is suspected in contributing to five deaths.

The lead is prone to developing hairline fractures, which has the potential to misread heart rhythms, which is critical to the defibrillator's operation. A fracture in the lead could cause the defibrillator to malfunction in two ways: by delivering an unnecessary, and often extremely painful shock to the heart when it isn't needed, or failure to deliver a critical impulse to the heart to restore proper rhythm.

Pacemakers are not affected.

Medtronic says in the October 15th edition of the New York Times that it has stopped selling the fracture-prone leads, and will be recalling leads already out in the market, ensuring they will not be implanted from hereon in.

It is estimated that 235,000 patients could be affected. This number represents patients who received a Medtronic defibrillator since 2004. Patients receiving a Medtronic defibrillator prior to that time should not be affected - nor would those who initially had a defibrillator implanted prior to 2004, but may have had a replacement since that time. In this situation, it is common for doctors to use an existing lead, rather than replace the wire. The latter involves delicate surgery, and considered a higher risk than simply replacing the device itself.

It's for this reason that patients carrying the affected lead consult their doctor to determine the best response. Medtronic claims that defibrillators can be re-programmed to mitigate the potential for problems. Still, the manufacturer estimates that 2.3 per cent of patients fitted with the Fidelis lead would experience a fracture within 30 months of implantation. That figure translates to anywhere between 4,000 and 5,000 individuals that will be required to undergo the delicate and risky surgery needed to replace the fracture-prone lead.