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Ugh.

Medtronic Inc. has suspended distribution of its Sprint Fidelis defibrillation leads after identifying five patient deaths in which a lead fracture may have been a contributing factor.

Medtronic shares fell nearly 5 percent in premarket trading.

A defibrillator monitors a patient's heartbeat; if it senses an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart.

Medtronic said Monday it had discovered a "small chance of fractures in particular locations" on Sprint Fidelis models 6930, 6931, 6948 and 6949. The company is asking doctors to stop implanting the leads and return all unused leads to Medtronic.

A fractured lead "can cause the defibrillator to deliver unnecessary shocks or not operate at all," said Daniel Schultz, director of the Food and Drug Administration's Center for Devices and Radiological Health.

The company is not recommending that patients with such a lead have it removed, since they "are more likely to experience complications from removal." Instead, Medtronic said, doctors can reprogram the device to alert the patient that a fracture may have occurred. Possible indicators could include audible alerts or inappropriate shocks.

The stock is getting crushed today. The shares went as low as $50.20.

Posted by edelfenbein at October 15, 2007 10:36 AM