On October 15, 2007, Medtronic voluntarily suspended distribution of the Sprint Fidelis lead due to growing concerns regarding an abnormally high fracture rate with 665 lead failures and 5 potential resultant deaths (12). Initial performance reports from Medtronic did not identify a statistically significant difference in lead survival compared with other lead models such as the Sprint Quattro, although the difference was projected to reach statistical significance if the failure rate remained constant. Recommendations regarding management included routine monitoring with adjustment of impedance alarm thresholds. Medtronic and its Independent Physician Quality Panel deemed the current failure rate of 2.3% at 30 months inadequate to justify prophylactic lead replacement, citing major complication rates of extraction between 1.4% and 7.3% (8,13-15).. Since this initial report, several groups have reported observations of higher failure rates (2,3,16). Krahn et al. (16) described a 3.91% failure ...
Fracture of a transvenous high-voltage ICD lead was first observed in the original CPI Endotak model in 1988.8 Patients who had this lead suffered multiple inappropriate shocks, and it was withdrawn from clinical trial. Since then, conductor fractures and insulation disruption have challenged engineers and physicians to develop improved designs and implant techniques. Progress has been made, but not without setbacks. The Medtronic Transvene lead, a coaxial polyurethane design introduced in 1993 and implanted in ,24 000 patients, exhibited both insulation degradation and conductor fractures; these failures typically appeared ≥4 years after implant and most commonly presented as inappropriate shocks.9 A mismatch between the terminal pin of the Boston Scientific Endotak DSP and the pulse generator connector header resulted in insulation and conductor defects when the pin punctured the lead; again, inappropriate shocks were the usual consequence. Surgical methods have contributed to lead failure, ...
Neuromuscular-incapacitating devices (NID) are being used increasingly worldwide by law-enforcement authorities to restrain violent behavior.1 Electrical noise-related, inappropriate detection by implantable cardioverter-defibrillator (ICD) has been documented.2,3 Detection of NID discharge by ICD has been described,4,5 but the effects of duration of NID discharge and ICD detection and therapy have not been established. The authors hypothesized that a longer duration of NID energy might lead to shocks from the defibrillator.4. With the approval of the animal care committee of our institution, we tested this hypothesis in a pig implanted with Medtronic 7275 GEM III DR ICD. The method used for performing the experiment in a pig model has been described previously.6 In the present study, we used subcutaneous insertion of the darts. Particular attention was given to ensure that the darts were in the subcutaneous tissue and not any deeper, to avoid any possibility of direct stimulation through the ...
Medtronic Sprint Fidelis Defibrillator leads - Find trial lawyers and attorneys with experience in lawsuits involving Medtronic Sprint Fidelis Defibrillator leads. Contact an attorney who can help yo
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Reports of frequent fracturing of Sprint Fidelis leads on Medtronic implantable defibrillators had been piling up for months, but the company only chose to withdraw the defective leads earlier this week.
There are two possible options of you have type of the high increased risk Sprint Fidelis lead connection implants. First, all your doctor can suggest so that it will you to add that you simply replacement lead wire but this does not suggest that your existing incorrect lead wire will indeed be removed. In fact, doctors as well on the grounds that the FDA have cautioned that removing the dental implants routinely is not really the best and solidest option. The also option is to very carefully monitor the patient to suit any clear signs connected lead wire fracture ...
Leads under advisory may vary considerably with regard to their potential for failure. The clinical implications of failure and timing of failure can be variable and different among patients. As a result, the management also can vary significantly, from close surveillance to a complex reoperation involving lead extraction. Analysis of the Accufix (Teletronics) pacing lead advisory showed a 10-fold increase in complications when leads were extracted compared with leaving the recalled lead in place.15 This observation showed that careful consideration must be used in the setting of an advisory before device replacement or lead extraction. Amin et al16 proposed a Markov decision-analysis model to compare risks and benefits for elective device replacement in devices under advisory. Their findings suggested that the main factor affecting whether a device should be removed is the estimated risk of device failure. In contrast, lead advisories represent an entirely distinct problem compared with device ...
A dynamic blending gas delivery system and method are disclosed. A blended gaseous mixture produced in accordance with the method is used in chemical vapor deposition tools or similar process tools. One embodiment is a multi-step method for processing a plurality of fluids to form a blended gaseous mixture and supplying the blended gaseous mixture to a distribution header from which the blended gaseous mixture is delivered to at least one tool. The first step is to supply a first fluid. The second step is to heat the first fluid to a temperature where at least some portion of the first fluid is a vapor. The third step is to superheat the vapor portion of the first fluid to a temperature sufficient to avoid condensation of the blended gaseous mixture delivered to the at least one tool. The fourth step is to supply a second fluid. The fifth step is to heat the second fluid to a temperature sufficient to avoid condensation of the superheated vapor portion of the first fluid when the superheated vapor
Implantable devices, including valves, stents, occlusion devices, pacemakers, and debrillator systems, have become widespread and indispensable tools for cardiovascular therapy. Subjected as they are to the incessantly dynamic mechanical environment of a beating heart, a fundamental component of demonstrating safety, and one of the basic regulatory challenges, is testing to ensure their physical resilience and resistance to fatigue failure. Fracture of such devices in situ has traditionally been considered a mark of failure, not simply in the material sense, and although such failures are not always catastrophic, they are still cause for concern. With the introduction of ultra-noncompliant angioplasty balloons, it is now conceivable and feasible to impose intentional overload fracture of some vascular and valvar prostheses for therapeutic rather than for detrimental effect. The report by Chhatriwalla et al1 in the current issue of Circulation: Cardiovascular Interventions adds to a growing ...
The disclosure describes implantable medical systems that respond to occurrence of a lead-related condition by utilizing an elongated coil electrode in defining an alternative pacing therapy vector to maintain optimal drain of an IMD power supply. An exemplary system includes a medical electrical lead having an elongated electrode and an improved sensing and therapy delivery circuitry to provide the alternative pacing therapy vector responsive to the lead-related conditions. The system includes circuitry for recognition of the lead type in order to respond to the occurrence of the lead-related condition.
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Torrance Refining Co., the 155,000 bpd southern California refinery PBF Energy recently acquired from ExxonMobil, has been forced to shut down this week after a series of equipment failures struck the facility following a software update.
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I was seven miles into my 25 mile lunch ride along the Bay. I downshifted as I started up a hill; the brifter went clickclickclick but there was, oddly, no resistance. I looked back at my rear dérailleur and it was in its smallest cog. I tugged at the dérailleur cable and thats when the housing popped out of the brifter with the frayed cable poking out. Drat. Im riding northeast and I have 10-15 mph winds out of the north along the Bay, with rolling hills. Do I continue my ride, pushing against the headwind in the big gear? Or do I turn around? What decision would you make?. ...
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Cheryl Cole looked stunning at the Elle Style Awards, but tit tape was on show. Photos: Getty Nobody could deny that Chezza looked the best.What do you think?See all the stars and style at the Ell...
For all the reports of equipment failures and close calls and controller burnout, the nations air-traffic-control system is in fact far less precarious, in terms of safety, than people imagine it to be. The real threat to the systems integrity has as yet received little attention
Sorry for the delay in our service, blogger went down on Thursday night and took all recent articles with it, service was just restored a few minutes ago. We have been able to restore most of the stories, but all comments on the stories have been deleted due to Googles malfunction, sorry for the inconvenience. Thanks for your patience and for reading DCMud ...
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What has been your worst wardrobe malfunction? What was the most embarrassing fashion moment you have had so far? I will tell you about mine, and hopefully, how to avoid this happening to you at some point! One day, my husband and I needed to go...
Fingerprint Dive into the research topics of Percutaneous pacemaker or implantable cardioverter-defibrillator lead removal in an attempt to improve symptomatic tricuspid regurgitation. Together they form a unique fingerprint. ...
Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads - Medical Devices Pipeline Assessment, 2017 Summary GlobalDatas Medical Devices sector report,
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One embodiment of the present invention provides an implantable cardioverter-defibrillator for subcutaneous positioning over a patients ribcage, the implantable cardioverter-defibrillator including a housing, wherein the housing conforms to the patients ribcage when subcutaneously positioned; an electrode disposed upon a portion of the housing; and an electrical circuit located within the housing, wherein the electrical circuit is electrically coupled to the electrode.
ECOST, a prospective multicentre clinical trial designed to examine the safety and effectiveness of remote monitoring of implantable cardioverter-defibrillator (ICD) patients with Biotronik Home Monitoring, demonstrates for the first time that daily remote monitoring with Biotronik Home Monitoring reduces inappropriate shocks and improves battery longevity in long-term follow-up (27 months) of patients with an ICD. The results were presented by Salem Kacet, principal investigator of the trial, at the European Society of Cardiology (ESC) Congress 2011 on 29 August 2011 in Paris, France.. Researchers analysed 433 patients who were randomly assigned to Home Monitoring follow-up or standard in-office care. Patients in the Home Monitoring group were scheduled for in-office follow-ups at yearly intervals. In between, device- or patient-related event notifications by the Home Monitoring system could trigger additional in-office follow-ups. Patients in the control group received standard of care with ...
EB NEURO offers a wide variety of disposable and multi-use duodenal catheters for conventional and high-resolution manometry. Disposable catheters are available in different configurations that reach up to 24 pressure channels and offer many benefits: no need for disinfection (time-saving), no risk of infection and no risk of deletion of day of exams due to catheter malfunction. Multi-use catheters are available with configurations that reach up to 36 pressure channels and up to 12 impedance channels. They are available in silicon and in PVC. You can customize your catheter on request.. ...
Read Oversensing of the wearable cardioverter defibrillator during bipolar ventricular stimulation, Wiener klinische Wochenschrift on DeepDyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips.
ContextRecent implantable cardioverter-defibrillator (ICD) advisories and recalls have caused management dilemmas for physicians, particularly because there are
The Particulars: Previous studies have suggested that the rates of implantable cardioverter defibrillator (ICD) lead fractures are high among young patients. This patient population has also been found to be at risk for venous occlusion with transvenous ICD lead placement. A minimally invasive epicardial ICD placement may provide younger patients with a more desirable treatment alternative.. Data Breakdown: Investigators reviewed the charts of 22 children who underwent ICD placement using an epicardial pace/sense lead and a separate coil that was placed laterally-posterior to the pericardial sack through a 2 cm submammary incision-and tunneled the leads to an abdominal generator. All patients in the study had successful ICD implantations, and there were no deaths at 20 months follow-up. One patient required a right ventricle lead replacement. Another patient experienced an ICD generator failure but did not have problems with the lead or coil. Two other patients required drainage of a pleural ...
Learn how cardiac specialists use an implantable cardiac defibrillator for arrhythmia treatment at the Heart & Vascular Center, Brigham and Womens Hospital
Chronic complications include the following: Device-related pain Lead fracture Inappropriate shocks Erosion of device through skin Immunologic rejection - Rare
Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials.
Out of 200,909 implants, 3,390 patients (1.7%) developed an ICD infection. The infection rate was 1.4%, 1.5%, and 2.0% for single, dual, and biventricular ICDs, respectively (p < 0.001). Generator replacement had a higher rate compared to initial implant (1.9% vs. 1.6%, p < 0.001). The factors associated with infection were adverse event during implant requiring reintervention (odds ratio [OR], 2.692; 95% confidence interval [CI], 2.304-3.145), prior valvular surgery (OR, 1.525; 95% CI, 1.375-1.692), reimplantation for device upgrade, malfunction, or manufacturer advisory (OR, 1.354; 95% CI, 1.196-1.533), renal failure on dialysis (OR, 1.342; 95% CI, 1.123-1.604), chronic lung disease (OR, 1.215; 95% CI, 1.125-1.312), cerebrovascular disease (OR, 1.172; 95% CI, 1.076-1.276), and warfarin (OR, 1.155; 95% CI, 1.060-1.257).. ...
Currently, explains investigator Dr Philippe Mabo form the University Hospital of Rennes, France, regular in-clinic follow-up must be performed every three months, according to manufacturer guidelines. But there are two drawbacks to the in-clinic follow-up - theyre time-constrained for both the patient and the clinic, and theres no link between the time of the appointment and the clinical event or device malfunction. So theres a clinical need to consider new follow-up strategy.. In response, several manufacturers have developed new technologies which allow the remote transmission of information from the device and on its therapeutic effect. Critical data can be transmitted at any time on system integrity or unexpected events - for example, lead integrity, battery status or ineffectively delivered therapy. Data stored in the device are transmitted by phone from the patients home to the implant centre, with website access to the data.. In this context, said Dr Mabo, remote device ...
Brody Davis is a fictional character created by Jason Katims for the 1999-2002 American science fiction television series Roswell. He is portrayed by actor Desmond Askew. Davis is a millionaire who takes over ownership of the UFO Center where Max Evans works. On a number of occasions, he claims to have been abducted by aliens. He tells Maria DeLuca that, in essence, his mind would go blank and he would awaken a few days later lacking knowledge of where he had been or what he had been doing. In reality, his body was being used as a vessel by aliens to come to Earth. He later tries to develop a device that will open a part of his brain that he believes contains memories of where he had been taken. This device malfunctions and the resulting shock reveals previously unknown memories to him, which leaves him confused and afraid. After this happens, he takes Max Evans, Tess Harding, Liz Parker, Maria, her mother and her cousin hostage. Max is able to heal the damage to part of Brodys brain using ...
A system and method are provided for detecting dislodgment of a right atrial endocardial lead implanted within a heart right atrium wherein the lead includes an electrode. Atrial and ventricular activity of the heart are sensed with one other lead during a time period. Also during the time period, heart activity is sensed with the endocardial lead electrode. The sensed heart activity is stored in memory. The stored heart activity sensed with the one other lead is analyzed to establish a first time window from the sensed atrial heart activity and a second time window from the sensed ventricular activity. The heart activity sensed with the endocardial lead electrode during the first time window is then compared to the heart activity sensed with the endocardial lead electrode during the second time window.
A hidden FDA database of medical device failures was shut down in June 2019. The database contains medical device reports submitted to the FDA via its
Reducing application downtime during failover including identifying a critical line in the startup of an application, the critical line comprising the point in the startup of the application in which the application begins to use dependent resources; checkpointing the application at the critical line of startup; identifying a failure in the application; and restarting the application from the checkpointed application at the critical line.
Written in C#, this small program is used to log computer uptime and downtime for purposes of calculating power consumption and costs as well as savings, where downtime is considered either standby or hibernate. Written in C#, this small program is used to log computer uptime and downtime for purposes of calculating power consumption and costs as well as savings, where downtime is considered either standby or hibernate.
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HC,. Point taken. The scourge of predatory medicine is a black mark for all doctors, whether it is spinal fusions, coronary stents, or even cardiac devices. I have been a long-standing, outspoken advocate for applying clinical judgment in the use of ICDs. Even before I read this important, but infrequently cited Josephson piece, I was mindful of the limitations of ICD, and the flaws of the prophylactic ICD trials. I was on the front lines of the first recalls, and I am still living with the Sprint Fidelis debacle. My wife is a palliative care doctor, so I understand the concept of all-cause mortality versus arrhythmic-mortality. The unfairness of life though, is that swinging pendulums whack everybody-even those that apply (and have applied) critical thinking. Perhaps, the present-day intrusions into the doctor-patient relationship are getting to me. As Malcolm Gladwell writes about in his recent book What the Dog Saw, the outlier, egregious (Midei-like) cases dont follow a predictable ...
A computer implemented method may be used for analyzing equipment failures and maintenance schedules. An equipment maintenance system generates a model of equipment and components of each piece of equ
Acute emergency unit is located in 1st. floor of block A.. Unit is open 24/7, and provides care for patients with acute cardiac conditions such as Myocardial infarction suspection, heart rhytm disturbances, arrhytmia, dyspnea, and suspection of implanted device failure.. Contact:. ...
(WCNC) As lawsuits make their way through the legal system, a doctor in Charlotte, North Carolina is trying to prevent the massive equipment failures that led to last year
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During My ASA in July i was taken back into surgery To get an ICD that Same Afternoon. My hearth had gone CHB once the first .5ml of alcohol was infused.5
Victorias Health Minister has blasted one of Melbournes largest hospitals for falling well short of standards after more than 500 operations were cancelled due to an equipment malfunction.
The description of diagnostics of electronic control systems and diagnostic codes are provided in the Head of System of electric equipment of the engine. In this section the simplest scheme of clarification of the reasons of malfunctions and the refusals occurring in knots and systems of a vehicle is offered. Refusals and their possible reasons are broken into groups on the basis of the relation to certain components or car systems, such as the engine, cooling system, etc., besides, in the text references to chapters and sections concerning these problems are given. Remember that the successful conclusion of search of causes of defect at all is not the black magic available to only skilled professional mechanics, and is defined by a combination of a certain knowledge and a patient, systematic approach to problem research. To move always follows from simple to difficult, to lead up each check to the logic end and to try not to pass the obvious facts - everyone can forget to fill fuel in a fuel ...
This study is a non-randomized, multi-site, clinical study of implanted commercially available Model 4195 leads. Data will be collected prospectively; however, retrospective study enrollment will be allowed to include leads implanted through the Attain StarFix Model 4195 LV Lead pre-market study. All enrolled subjects have been implanted with a Model 4195 LV Lead. This study is designed to monitor long term performance of the Model 4195 lead and to identify individual failure modes.The objective of the study is to demonstrate that the Model 4195 lead-related complication-free probability is greater than 92.5% at five years post-implant ...
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Learn more about the risks of implantable cardioverter-defibrillator (ICD) insertion, including swelling, bruising, or serious conditions like stroke.
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The Blogworm is designed to keep you up-to-date with whats happening in the Library. Please feel free to comment on any of our posts with your questions and well get back to you with a response ...
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Purple, a gas delivery startup, is one sign of where things are going. While the government and labor ponder the future, Purple is already selling a service that allows you to order gasoline for your car and have it fueled wherever the vehicle is currently parked. .... ...
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Akwesasne - General Manager of CKON, Diane McDonald, explained why they have been off the air several times over the past few weeks saying,
I hope to get out on the road with my custom solar trailer as soon as possible. I really enjoyed building this one-of-a-kind unit. My idea has become to add more solar and try to stay out for maybe 30 days vs. most RVs that can boondock for max 3-7 days. If you have some ideas on something that you would really, like to have in your dream trailer - RV please let me know. If I install it then Ill be able to work out the kinks for you. Having almost completed Version one 95% I have decided it did not meet my design goals and have now built this 2013 CarMate - which is turning out much better then expected, but the going is slow as I am still working on my regular ol job ...
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An ablating device has a cover which holds an interface material such as a gel. The cover contains the interface material during initial placement of the device. The ablating device may also have a removable tip or a membrane filled with fluid. In still another aspect, the ablating device may be submerged in liquid during operation.
PD testing is an important investment for your plant. It is no secret that if you are running a high value plant, then electrical installations will be amongst the most valuable assets in your installations. A downtime, even for a few hours, will severely affect your business bottomlines and result in catastrophic financial losses.. When operating your electrical systems at higher levels, you will have to grapple with the long-term reliability of electrical systems - including problems with partial electrical discharge. But what is partial discharge in the first place?. Before you embark into the merits of PD testing, it is important to understand what this electrical fault entails. After all, PD might occur over many years without you even realizing it.. Partial Discharge (PD). PD occurs when your electrical insulations break down due to high or medium electrical voltage stresses. PD can be catastrophic because once the breakdown in the insulation has been initiated, the deterioration will be ...