Victim of defective defibrillator lobbies for Medical Device Safety Act

April 6th, 2009 by Jennifer Walker-Journey

medtronic pacemaker 150x150Ron Albrecht lives in fear – fear that one day he will learn that the defibrillator implanted in his chest is defective and will cause him excruciating pain when it fails, like his previous one did two years ago. That device turned out to be among the defective heart defibrillators that were recalled by the device’s manufacturer, Medtronic. Albrecht’s device had to be replaced, and while his new one appears to be operating fine, he still worries.

“I don’t trust the unit itself,” he told NWI.com. “You’ve got that fear you’re constantly going to get shocked. It’s very traumatic.”

Because of the faulty , Albrecht had to quit his job because he was no longer able to lift heavy equipment. The defective device, he said, has changed his life for the worse.

In 1997, suspended sales of its Sprint Fidelis Defibrillators after deaths were linked to the devices. The device’s leads were found to have fractured, which caused them to unnecessarily shock patients or fail to work altogether, putting patients’ lives at risk.

Albrecht was one of the many patients who tried to sue over his faulty leads but previous legislation prevented him and other victims from doing so. Earlier this week, Albrecht and several victims of malfunctioned heart devices converged in Washington, D.C. to lobby for support of the Medical Device Safety Act, which would allow consumers who have been hurt by defective medical devices to sue the device’s maker even if the devices have been approved by the Food and Drug Administration (FDA).

A spokesman with says the industry as a whole is resistant to the proposed act, stating that a 1978 federal law was enacted to ensure that the FDA operates as the arbiter of safety.

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