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Food and Drug Administration 233 articles

Did Medtronic act quickly enough on recall

Medtronic issued the recall of leads in October, amid mounting evidence that a small percentage of the leads were fracturing. Those fractures caused some patients to receive unneccessary shocks from their defibrillators, while other patients did not receive a lifesaving shock when they had a slow heart rhythm. The lead failures may have contributed to five deaths. At the time of the recall, Medtronic took great pains to underscore that the Fidelis leads had a 2.3 percent failure rate after 30 months of implantation. That compared to a 1 percent failure rate among the company’s Quattro leads, which have been ... Read More

Safety concerns over defibrillator wires

Shares of medical device maker St. Jude Medical could face pressure Monday on a media report that raised safety concerns over some of its defibrillator wires. The Wall Street Journal reported Monday that in rare instances, the company’s Riata line of defibrillator leads are poking holes through the hearts of cardiac patients rather than remaining attached to the heart wall. The leads connect a patients heart to an implantable defibrillator, which helps maintain a proper heart rhythm. The cases have been reported to the Food and Drug Administration. The newspaper said the most recent cases involve the accounts of four ... Read More

A patient an advocate a fixer

When it comes to her health, Laurel Lewis is positively fearless. The 54-year-old Minneapolis woman has stared down a rare breed of late-stage cancer. And last year, she technically died after her heart stopped beating, but luckily her near-fatal attack occurred just outside Fairview Southdale Hospital in Edina. She left the hospital with an implantable cardioverter defibrillator (ICD) made by Medtronic Inc. tucked inside her chest, a kind of medical-device insurance policy intended to shock her heart back into rhythm if she goes into sudden cardiac arrest. “I have faced the darkest day,” she said recently. But on Oct. 15, ... Read More

Common MRI poisoning some kidney patients

If she knew then what she knows now, Sarah Fracella would not have undergone an MRI. “I don’t think there’s been a day in the last, probably, two years that’s gone by that I haven’t cried at least once about this,” said Fracella, 38, of Santa Barbara, whose skin is hardening painfully into something that looks startlingly like marble. Fracella is one of as many as 1,000 people worldwide who have contracted a debilitating, incurable and sometimes fatal disease called nephrogenic systemic fibrosis, or NSF, from the dye that is used in millions of magnetic resonance imaging scans every year. ... Read More

Patients concerned about Medtronic Sprint Fidelis leads

Patients who have been implanted with [Medtronic Sprint Fidelis Leads] are understandably concerned after learning that the leads have been linked to five fatalities. Some patients have undergone risky surgeries in order to have the leads removed after they malfunctioned. Meanwhile, [lawsuits] have been filed on behalf of patients who were injured by fractured leads. The leads were implanted into hundreds of thousands of patients who are now at risk of serious injury if their Sprint Fidelis Lead malfunctions. All unused leads were recalled by Medtronic on October 15, although Medtronic is actually referring to the recall as a “voluntary ... Read More

NorCal man blames MRI dyes for illness

An elderly man has sued several major health companies, claiming the dyes used to scan his failing kidneys caused a rare, painful and incurable disease. Peter Gerber, 72, of San Rafael, contends that injections of dyes containing the heavy metal gadolinium caused him to develop nephrogenic systemic fibrosis, or NSF. Also known as nephrogenic fibrosing demopathy, the disease can thicken the skin, stiffen joints, restrict movement and potentially lead to death if it affects internal organs. Only about 215 cases have been reported worldwide, all involving people with kidney disease. No cures have been reported but some patients have seen ... Read More

History of hernia patch raises questions on implant recalls

How do makers of implanted medical devices react when one of their products starts breaking? One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue. At the time, Bard executives said they knew about some serious injuries potentially caused by the device, which is known as the Kugel patch. Since then, the Food and ... Read More

Medtronic recall exposes gaps in medical safety

In late January, something unsettling happened at the Minneapolis Heart Institute. On two successive days, patients came to the clinic after their heart defibrillators had jolted them with huge, unnecessary and painful electric shocks. One 65-year-old woman said she’d been zapped 14 times in an hour. Doctors checked the hospital’s records and discovered four similar cases had occurred in recent months. Each stemmed from a broken wire — called a lead — that tells a defibrillator when to send an electric shock to a malfunctioning heart. All six cases involved the Sprint Fidelis 6949, manufactured by Medtronic Inc., a leading ... Read More

MRI contrast agents get strong kidney-risk warning

Certain contrast agents used in magnetic resonance imaging — gadolinium-based products made by Bayer AG, GE and others — will now carry the U.S. Food and Drug Administration’s strongest, “black box” warning. The FDA’s move on Friday finalizes its announcement in May that it would add the labeling warning to the MRI contrast agents. The final warning notes that the agent boosts the risk of a potentially fatal side effect in patients with certain kidney and liver conditions. The skin disease called nephrogenic systemic fibrosis, or NSF, can occur in some patients, the companies said in a joint letter to ... Read More

Drug industry seeks tests to spot side effect risks

Seven major pharmaceutical companies are banding together to develop genetic tests that predict which patients will have adverse side effects from drugs. The group, a nonprofit organization dubbed the International Serious Adverse Events Consortium (SAEC), will conduct two studies, one to look at drug-related liver toxicity and the other aimed at a rare drug-related skin condition called Stevens-Johnson syndrome. “SAEC’s focus is to identify and to validate DNA variance or genetic markers that are useful in predicting a drug-induced serious adverse event,” Arthur Holden, the chairman of the group, said during a midmorning teleconference Thursday. The findings of the consortium ... Read More