DYER | Ron Albrecht was sleeping one night when excruciating pain jolted him awake.
"It was like a horse or elephant, kicking you from inside of your chest, out," the 62-year-old Dyer man said.
The pain happened twice that weekend in September 2007, and doctors soon discovered that a lead in his heart defibrillator was fractured, sending the waves of shock through Albrecht's body.
Albrecht had the device implanted in April 2006, after the lower section of his heart was damaged by a heart attack. When it malfunctioned in 2007, doctors put a cap on the faulty lead and implanted a new one. By then, the damage was done, he said.
He had to retire early because his job tasks included carrying parts and unloading trucks.
"I've got four granddaughters, and one of them I can't pick up because of the restriction in my shoulder," he said.
He's being affected psychologically, too, he said.
"I don't trust the unit itself," he said. "You've got that fear you're constantly going to get shocked. It's very traumatic."
Albrecht tried to sue the manufacturer, Medtronic. But existing legislation prevents him.
He took his story to Washington, D.C., this week, lobbying alongside other victims of malfunctioned medical devices, in support of the Medical Device Safety Act, HR 1346/S 540. The legislation would provide some recourse.
Rob Clark, spokesman for Medtronic, cannot address Albrecht's situation, because of pending litigation, but he explained the industry's resistance to the proposed Medical Device Safety Act.
A 1976 federal law holds different legal standards for makers of some complex medical technologies. Fewer than 2 percent of devices, typically ones that are implanted, fall into that category, Clark said.
It was enacted to ensure that a central body - in this case the FDA - operates as the arbiter of safety. The proposed legislation would roll back the clock 30 years and allow juries composed of laypersons to make determinations of the safety of these complex devices, Clark said.
"What the industry believes is the current system is effective and works for the preponderance of patients," he said.
A 2008 Supreme Court ruling upheld the 1976 law, stating that the FDA is the appropriate authority over certain devices, Clark said.
The defibrillator leads were recalled in October 2007, according to the FDA Web site.
Clark said it was a field action, not a recall. The recommendation was not to remove the device unless there was a known fracture in a patient's lead or if it delivered an inappropriate shock. Otherwise, it should be left in and heavily monitored, he said.
Posted in Local on Friday, April 3, 2009 12:00 am Updated: 2:16 am.
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