Medtronic warns of defect with 37,000 pacemakers

Article by: Associated Press
Updated: May 19, 2009 - 4:34 PM

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Medtronic is warning doctors that 37,000 of its pacemakers may have wiring defects that can cause them to malfunction.

The Fridley-based medical device company said in a letter to physicians that the defect affects a subset of its Kappa and Sigma pacemakers, causing them not to respond or run out of battery power. About 1.7 million of the pacemakers have been implanted since 1997, the company estimates.

Medtronic says it has received two reports of patient deaths where the pacemakers may have played a role.

The company says physicians should consider removing a pacemaker if their patient depends on the device for daily survival. Patients should call their doctor immediately if they experience symptoms, including fainting or lightheadedness.

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