Sprint fidelis lead fracture

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Web1 Jan 2010 · In October 2007, Medtronic voluntarily stopped selling its Sprint Fidelis ICD lead after observing an abnormally high rate of lead failure. A total of approximately … WebTable 1 shows the performance of the high voltage conductors of the Sprint Fidelis Model 6949 lead following a pace-sense conductor fracture. The analysis, while limited by a small sample size, indicates there is an increased risk for a high voltage conductor fracture if a pace-sense conductor fracture has previously occurred.

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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. ... 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, … most playoff points nba history

Class 1 Device Recall Medtronic Sprint Fidelis Lead - Food and …

Web28 Aug 2024 · Sprint Fidelis implantable cardioverter-defibrillator (ICD) leads, which were placed under an advisory and recalled more than a decade ago due to an elevated risk of … 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 … 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 ... mini fish bowl heater

The Medtronic Sprint Fidelis® lead history revisited-Extended

Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - risk ...

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 … mini fish cookie cutterWeb1 Jun 2013 · This retrospective study analyzed 25 explanted dual-coil (model 6949) Fidelis leads with confirmed HV fractures of either the right ventricular (RV) coil and/or superior … mini fish bowl glasses

"Web3 May 2016 · The Fidelis lead survival rate after generator replacement does not differ from that of the Fidelis leads that have not had replacement. In the event of generator replacement with no manifestation of lead fracture, the lead model, patient age and life expectancy, ejection fraction, comorbidities, ease of extraction, local extraction expertise, … " - Sprint fidelis lead fracture

Sprint fidelis lead fracture

$The Sprint Fidelis lead fracture story: What do we really know and ...$

Web1 Jun 2013 · Fracture of a pace/sense (P/S) conductor is the most widely studied failure mode of the Sprint Fidelis (Medtronic, Minneapolis, MN) lead. 1 Fractures of high-voltage (HV) conductors are much less common; however, unlike P/S fractures, they may result in failed defibrillation. 2, 3 Data from the returned product analysis (RPA) of Fidelis leads ... Web18 Dec 2012 · Sprint Fidelis lead fractures in patients with cardiac resynchronization therapy devices: insight from the Resynchronization/Defibrillation for Ambulatory Heart …

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Web1 Jan 2010 · Search worldwide, life-sciences literature Search. Advanced Search Coronavirus articles and preprints Search examples: "breast cancer" Smith J 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 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. Web25 rows · 133 patient scans with Fidelis lead fractures. 133 patient scans with normally functioning Fidelis leads. Six parameters including lead slack, anterior/posterior …

WebIf a Fidelis pace-sense conductor fracture has occurred, we recommend implanting a new high voltage lead, with or without extraction of the Fidelis lead. It is no longer a recommended option to implant a pace-sense lead while maintaining use of the Fidelis high voltage conductors after a Fidelis pace-sense conductor fracture has occurred. 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 …

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 …

WebBackground: Sprint Fidelis (Medtronic Inc., Minneapolis, Minnesota) is a 6.6-F implantable cardioverter-defibrillator lead. In October 2007 the manufacturer suspended distribution … most playoff points nhl single seasonWeb1 Jan 2010 · The aim of this study was to investigate the rate of Sprint Fidelis lead failure, the characteristics, the mode of presentation and possible predictors of lead failure.Methods and Results. The rate, characteristics and presentation of Sprint Fidelis lead failure was assessed in this single-centre survey. 619 Sprint Fidelis ICD leads were … most playoff points nbaWeb6 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 … most playoff wins all timeWebAs 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 … most playoff receiving yardsWebIntroduction: The Sprint Fidelis 6949 implantable cardioverter defibrillator (ICD; Medtronic Inc., Minneapolis, MN, USA) lead has a high rate of fracture. Identification of predictors of … most playoff wins by a quarterbackWeb6 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. mini fish drawingWeb3 Feb 2024 · And it seems as though the fracture problems became worse over time. In the first two months of 2006, there were 27 reports of the Sprint Fidelis lead fracturing. But in the first two months of 2007, there were 152 reports. And since January 10, 2007, there have been a staggering 1,030 reports of fractures. Shortly after the Sprint Fidelis lead ... most playoff wins by nfl quarterback