And now another ICD warning; this time from Medtronic

It seems like implanted cardioverter defibrillators have some kind of evil eye upon them. Minnesota […]

It seems like implanted cardioverter defibrillators have some kind of evil eye upon them.

Minnesota device maker Medtronic warned physicians this week that its EnTrust and Escudo ICDs run the risk of early battery depletion.  Last year, Medtronic’s in-state rival St. Jude Medical was hit with a Class I recall of its Riata and the Riata ST leads  because of the potential for lead wires to tear through the insulation. Less than two years ago, Medtronic announced the settlement of the lawsuits related to the defective Sprint Fidelis family of leads that cost the device maker $268 million. And the Boston Scientific/Guidant saga over defective defibrillators and pacemakers is part of industry lore.

On Wednesday, a Medtronic spokeswoman stressed that there were no deaths or serious injuries reported due to the battery defect in EnTrust and Escudo devices. She added that the problem was detected in less than 0.1 percent of patients implanted with these devices..

“Typically, these heart devices have three months of normal operation after the device signals the need for replacement,” Tracy McNulty, the spokeswoman, said via email. “EnTrust devices may require replacement sooner than expected, and result in less than three months of normal operation once the device indicates the need for replacement.”

McNulty added that there are roughly 39,000 implanted EnTrust and Escudo devices. EnTrust ICDs were first approved in the U.S. in 2005, and Medtronic discontinued the line in April last year as part of a planned phase-out to make way for new products.

The U.S. Food and Drug Administration is aware of the warning, McNulty said, but she didn’t know when the agency would evaluate and classify it. An email to an FDA spokeswoman was not immediately returned.

The safety warning was first reported by theheart.org

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