http://www.medcitynews.com/2009/12/sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice/?utm_source=rss&utm_medium=rss&utm_campaign=sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice MedCity News Sat, 11 Feb 2012 15:17:29 +0000 hourly 1 http://wordpress.org/?v=3.2.1 http://www.medcitynews.com/2009/12/sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice/comment-page-1/#comment-61343 Minnesota med tech community on possible 510(k) overhaul: We’re not gonna take it…. : MedCity News Thu, 18 Feb 2010 19:04:30 +0000 http://www.medcitynews.com/?p=17000#comment-61343 [...] medical device industry has whispered (loudly) about its sees as the alarming demise of the 510(k): unflattering media coverage, stinging Congressional reports, endless delays from FDA regulators now determined to hold device [...] [...] medical device industry has whispered (loudly) about its sees as the alarming demise of the 510(k): unflattering media coverage, stinging Congressional reports, endless delays from FDA regulators now determined to hold device [...]

]]> http://www.medcitynews.com/2009/12/sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice/comment-page-1/#comment-56524 Night Read (Minnesota): Emergency treatment center to compete with Woodwinds hospital in Woodbury : MedCity News Thu, 04 Feb 2010 02:27:42 +0000 http://www.medcitynews.com/?p=17000#comment-56524 [...] publicly disclosed, according to the Wall Street Journal. Medtronic, based in Fridley, pulled the Sprint Fidelis defibrillator wires off the market in 2007 and substituted another type of wire with a lower failure rate. But an [...] [...] publicly disclosed, according to the Wall Street Journal. Medtronic, based in Fridley, pulled the Sprint Fidelis defibrillator wires off the market in 2007 and substituted another type of wire with a lower failure rate. But an [...]

]]> http://www.medcitynews.com/2009/12/sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice/comment-page-1/#comment-53970 Minnesota health care firms crank up the heat on Congress last year : MedCity News Sat, 23 Jan 2010 02:45:57 +0000 http://www.medcitynews.com/?p=17000#comment-53970 [...] had already approved their devices, a doctrine known as preemption. The case stemmed from Medtronic’s recall of faulty Sprint Fidelis leads, which might have contributed to patients [...] [...] had already approved their devices, a doctrine known as preemption. The case stemmed from Medtronic’s recall of faulty Sprint Fidelis leads, which might have contributed to patients [...]

]]> http://www.medcitynews.com/2009/12/sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice/comment-page-1/#comment-51535 New Minnesota med device group seeks to save 510(k) program : MedCity News Wed, 13 Jan 2010 19:54:13 +0000 http://www.medcitynews.com/?p=17000#comment-51535 [...] MINNEAPOLIS, Minnesota– For months, the medical device community has been fretting over what they see as the Food and Drug Administration’s increasingly heavy handed way of approving new technologies. [...] [...] MINNEAPOLIS, Minnesota– For months, the medical device community has been fretting over what they see as the Food and Drug Administration’s increasingly heavy handed way of approving new technologies. [...]

]]> http://www.medcitynews.com/2009/12/sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice/comment-page-1/#comment-49739 Gerry Thu, 07 Jan 2010 12:14:05 +0000 http://www.medcitynews.com/?p=17000#comment-49739 Where's the data to backup this statement: "independent studies that predict failure rates could hit 30 percent by four years"? As a patient with a sprint fidelis lead implanted 4 years ago publishing articles like this without investigating and providing the facts seems wrong. Where’s the data to backup this statement: “independent studies that predict failure rates could hit 30 percent by four years”? As a patient with a sprint fidelis lead implanted 4 years ago publishing articles like this without investigating and providing the facts seems wrong.

]]> http://www.medcitynews.com/2009/12/sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice/comment-page-1/#comment-47624 Influential study slams FDA regulation of medical device industry : MedCity News Thu, 31 Dec 2009 19:10:01 +0000 http://www.medcitynews.com/?p=17000#comment-47624 [...] But one issue that particularly bothers big and small device companies alike is a general perception that the Food and Drug Administration is embracing a more populist approach to re... [...] [...] But one issue that particularly bothers big and small device companies alike is a general perception that the Food and Drug Administration is embracing a more populist approach to re… [...]

]]> http://www.medcitynews.com/2009/12/sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice/comment-page-1/#comment-47596 Tens of Thousands Of Heart Patients May Be At Risk From Defective Device | Injury Law Blog and News Thu, 31 Dec 2009 17:05:51 +0000 http://www.medcitynews.com/?p=17000#comment-47596 [...] the recall has been what is the failure rate of the device.   As noted in a December 29, 2009, Bloomberg article, “A report by UBS Investment Research Monday said lead failures could accelerate over time, [...] [...] the recall has been what is the failure rate of the device.   As noted in a December 29, 2009, Bloomberg article, “A report by UBS Investment Research Monday said lead failures could accelerate over time, [...]

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