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The U.S. Food and Drug Administration (FDA) approved a software update from Medtronic that will help detect fractures in the company’s Sprint Fidelis cardiac defibrillator lead. The software will alert both patients and physicians of a possible fracture in the defibrillator lead. Earlier intervention in the event of such a fracture will help patients avert the serious complications that can arise.
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.
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.
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.
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.
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.
