Defective Medtronic Defribillators Result in Five Deaths

Amy Rothschild

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Medtronic is the largest manufacturer of implantable heart debrillators. Medtronic producess 55% of the market share in the United States of these devices. Last year, its sales reached $12.3 biillion dollars, with the bulk of the sales being for the sale of the potentially defective device. On Monday, October 15, 2007, Medtronic announced that it was putting a stop to the sales of the Spring Fidelis lead, a wire that connects the heart to the Medtronic defibrillator to the heart, after it was determined the leads could be potentially defective. After hundreds of reports of indicating possible malfunction, Medtronic is also encouraging physicians to stop using the Spring Fidelis. The Spring Fidelis is suspected of contributing to the deaths of five individuals.

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.

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.

Medtronic has announced that it will cover the cost of the faulty lead, and contribute up to $800 worth of medical costs not covered by insurance. However, the manufacturer will not cover the cost of replacing a functioning lead.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.