Sprint fidelis lead
Web15 Oct 2007 · Sprint Fidelis. Lead Patient Management Recommendations. This letter provides important information on Sprint Fidelis lead performance and recommendations … Web1 Oct 2013 · A total of 520 patients had Sprint Fidelis leads implanted between December 2003 and October 2007 at the study center; 217 patients underwent lead replacement (213 underwent a lead abandonment strategy and 4 underwent a lead extraction strategy). Mean follow-up after lead replacement was 55 ± 33 months. In patients undergoing lead …
Sprint fidelis lead
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WebThe leads were found to be failing at an unacceptable rate, resulting in unnecessary shocks or no shocks when needed; either can be lethal. The scope of the problem continues to be a matter of research. Studies since the recall, disputed by Medtronic, suggest that the failure rate of already-implanted Sprint Fidelis leads is increasing ... Web20 May 2024 · The device is a pair of wires tied to a defibrillator designed to shock the heart back into a normal rhythm. By the time it was recalled in late 2007, the Sprint Fidelis had been implanted in the ...
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 … Weba Sprint Fidelis lead during the second procedure, in total we analysed 269 Sprint Fidelis leads. 390 N. Girerd et al. Implantation techniques Leads were inserted preferably via left-sided venous access by cephalic cut-down or, alternatively, from the subclavian vein
Web29 Jan 2016 · The Fidelis ® lead is an ICD lead with a small diameter that was approved by the FDA in 2004. It was recalled in 2007 when design defects were recognized that resulted in early fracture of... Web1 Jan 2010 · Download Citation Time-Dependent Risk of Fidelis Lead Failure The Medtronic Sprint Fidelis leads (models 6930, 6931, 6948, 6949) are 6.6-F bipolar high-voltage implantable cardioverter ...
Web15 Oct 2007 · The lead is a wire that connects the defibrillator to the heart. Medtronic has identified five patients whose deaths may have been related to a fractured Sprint Fidelis defibrillator lead....
Web12 Apr 2024 · We found a median of 2.5 supplements were approved per device per year, similar to previous reports in the literature. 7-9 Both the Sprint Fidelis and Riata cardiac leads were approved through supplements (180-day and real-time, respectively) to devices originally approved in the mid-1990s that each had 80 or more supplements through 2012. christina väthWeb1 Apr 2015 · The incidence of lead fracture increased with time, with a lead fracture incidence of 1.2% at 1 year, reaching 20.7% at 5 years In the group of 118 patients with Sprint Fidelis lead failure, the failure was detected in 70 patients (59%) after inappropriate shocks caused by lead failure, in 33 (28%) by LIA, and in 15 (13%) at the time of routine 3 … christina voitaWebOn October 14, 2007, Medtronic, Inc. announced a recall due to a defect in its Sprint Fidelis cardiac leads (thin wires) that are utilized to connect an implantable pacemaker or defibrillator directly to the heart. The following day, the New York Times published an article claiming that the flaw in this lead wire has caused numerous device malfunctions. christina von saß mannWebA total of 19 leads (13%) failed after 6.7 ± 3.2 years (range: 1.2-12.0). Overt malfunction with shocks existed in four patients (3%). Cumulative lead survival was 93.1% at 6, 88.2% at 8, 83.8% at 10, and 77.6% at 11 years, respectively, with 35% of implanted leads under monitoring at 10 years. christina von saß listalWebThe Medtronic Sprint Fidelis lead is a newer electrical wire which was introduced in 2004. Defibrillator leads are very fragile, and the Fidelis lead is a thinner type of the wire which was designed for easier insertion. However, there have been reports of several deaths and major complications. A fracture or break in the wire, could cause the ... christina von sassWebLead Type: Defibrillation: Type and/or Fixation: Active Screw In: Lead Function: Pacing/Sensing and Defibrillation: Lead Placement: Transvenous: Lead Tip Location: … christina von oranien-nassauWebSprint Fidelis leads, 62%, were the 65 cm model, and the The distribution of Fidelis failure as a function of time average time from Sprint Fidelis implant until data analysis after ICD … christina vu