Sprint fidelis lead fracture

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WebAs a result of careful post-market monitoring, Medtronic detected early signals that the Sprint Fidelis ICD leads may be fracturing at a rate higher than expected. Medtronic … Web15 Oct 2007 · The potential for defibrillation lead fracture to result in or contribute to inappropriate therapies or death has been previously reported. 2 As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide. Based on current information, we have identified five patient deaths in which a Sprint Fidelis lead ...

Generator exchange is associated with an increased rate of Sprint ...

WebBackground: Sprint Fidelis (Medtronic Inc., Minneapolis, Minnesota) is a 6.6-F implantable cardioverter-defibrillator lead. In October 2007 the manufacturer suspended distribution … Web4 Jul 2008 · There have been 17 lead fractures in our cohort of 480 Sprint Fidelis (model 6949) leads, median follow-up 19.8 months. The hazard of fracture increased significantly with time by a power of 2.74 (95% confidence interval: 2.57 to 2.91, P <.0001). Reprogrammed lead impedance thresholds prevented inappropriate shocks in only 1 of 6 … meghan markle podcast ratings october 2022

Sprint Fidelis Model 6949 Lead Performance - Medtronic

Web17 Jan 2011 · Sprint Fidelis (Fidelis) implantable cardioverter-defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few … Web17 Dec 2014 · Sprint Fidelis, model numbers: 6930, 6931, 6948 and 6949. Manufactured by Medtronic. Problem Risk of inappropriate shocks and loss of therapy. Increased risk that … Web1 Jun 2013 · Methods. This retrospective study analyzed HV fractures in explanted, dual-coil, model 6949 Sprint Fidelis leads (Medtronic, Minneapolis, MN). The study group consisted of 25 leads with structurally and electrically confirmed HV conductor fractures; 41 leads that were structurally and electrically intact served as controls. meghan markle portrayal on south park

$Sprint Fidelis lead fractures in patients with cardiac ...$

Sprint fidelis lead fracture

Characteristics of Sprint Fidelis lead failure. - Europe PMC

Web1 Oct 2008 · There have been 17 lead fractures in our cohort of 480 Sprint Fidelis (model 6949) leads, median follow-up 19.8 months. The hazard of fracture increased significantly with time by a power of 2.74 (95% confidence interval: 2.57 to 2.91, P <.0001). Reprogrammed lead impedance thresholds prevented inappropriate shocks in only 1 of 6 … Web15 Oct 2007 · The potential for defibrillation lead fracture to result in or contribute to inappropriate therapies or death has been previously reported. 2 As of October 4, 2007, …

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Web16 Nov 2012 · The Fidelis lead issue has provided invaluable information on lead behavior and risks for fracture. The Resynchronization/Defibrillation for Ambulatory Heart Failure … Web15 Oct 2007 · Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. ... suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the ...

Web1 May 2008 · Sprint Fidelis (models 6930, 6931, 6948, and 6949) is a 6.6 Fr bipolar high-voltage implantable cardioverter defibrillator (ICD) lead (Medtronic Inc., Minneapolis, MN, … Web6 Aug 2008 · Failure mechanisms of ICD leads may involve either the shocking coils and/or the pace/sense electrodes. The two major failure modes of the Fidelis leads relate to pace/sense conductor fractures, either of the cable to the anode (ring electrode) occurring near the tip of the lead or of the coil to the cathode (tip electrode) near the anchoring sleeve.

Web15 Jan 2008 · Medtronic has data showing that at 30 months, the viability of the Sprint Fidelis lead is lower than that of the company's Sprint Quattro lead (97.7% vs. 99.1%), which is not statistically different. However, “if the current lead fracture rates become constant,” the difference will become significant over time, the statement said. Web13 Mar 2009 · Sprint Fidelis® Model 6949 Lead Performance. March 13, 2009. ... The Panel has identified 13 patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. The Panel noted that four of the 13 deaths were associated with lead extraction, highlighting the risks associated with that procedure. ...

WebMost Sprint Fidelis failures were caused by pace-sense conductor fracture (n = 63 [87.5%]), which caused inappropriate shocks in 36 of 72 patients. Conclusion: The hazard of Sprint …

WebThe Lead Integrity Alert (LIA) provides three days advance notice prior to inappropriate therapy to 76% of patients with lead fractures 1. As a result, we strongly recommend that … meghan markle positive newsWebThe Sprint Fidelis Lead Advisory. The Sprint Fidelis lead advisory was issued in October 2007 in response to a growing concern regarding conductor fractures. 42 The first report on this issue was from a single center, which reported a failure rate of 1.0%, with a mean time to failure of 14 months, and cautioned centers to suspend implantation ... nand flash vppWeb6 Aug 2008 · from the University of Ottawa Heart Institute report on their single-center experience with 502 implanted Sprint Fidelis leads. The investigators report an increasing … nand flash wordlineWeb7 May 2008 · Because fewer leads have reached 33, 36, and 39 months of implant time, the confidence intervals shown in Table 2 are comparatively larger than those in Table 1. As more leads reach 33, 36 and 39 month implant points, our understanding of Sprint Fidelis lead performance will continue to increase. meghan markle pregnancy announcementWebIntroduction: The Sprint Fidelis 6949 implantable cardioverter defibrillator (ICD; Medtronic Inc., Minneapolis, MN, USA) lead has a high rate of fracture. Identification of predictors of … meghan markle pregnancy announcement dressWebTherefore, the more than 268,000 Sprint Fidelis leads were implanted, and purpose of this study was to review our entire experience even today, more than 100,000 patients still … meghan markle predictions 2023Web1 Jan 2010 · In October 2007, Fidelis leads were removed from the market. We sought to determine the time-dependent hazard of the Fidelis failure rate to date. A retrospective chart review was conducted in all patients who underwent implantation of a Sprint Fidelis lead (426 leads) at our center. We primarily implanted models 6931 and 6949. meghan markle podcast news