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Medtronic 630g Recall

Medtronic Announces U.s. Launch Of The Minimed 630g System

Medtronic Announces U.s. Launch Of The Minimed 630g System

Medtronic plc has launched its MiniMed 630G system with SmartGuard technology in the United States. U.S. Food and Drug Administration-approved for the treatment of people with diabetes mellitus sixteen years of age and older, the MiniMed 630G features a new insulin pump hardware platform and new user-friendly design that combines personalized diabetes management with clinical performance. The MiniMed 630G system is the newest member of the MiniMed family—the most prescribed integrated insulin delivery system brand in the world, according to Medtronic. After interviewing more than 1,000 people with diabetes and testing user-experience, the enhanced features of the MiniMed 630G system were finalized to take into account what matters most to those with diabetes. This collaborative process with the patient community resulted in a new, user-friendly pump design that is waterproof,1 has remote bolus functionality, and features a high-definition, full-color screen that supports easy navigation and enables increased customization with more intuitive menus. The MiniMed 630G system exclusively uses the Contour Next LINK 2.4 blood glucose meter from Ascensia Diabetes Care to provide blood glucose test results that have been shown to be highly accurate.2 The meter automatically transmits blood glucose results to calculate boluses using the Bolus Wizard calculator and to calibrate the CGM sensor, which helps prevent manual entry errors. It also allows patients to discreetly give themselves a bolus of insulin remotely from the meter, providing added convenience to help patients manage their diabetes effectively. "This latest innovation demonstrates Medtronic's vision to transform diabetes care to enable greater freedom and better health through a commitment to continually improving Continue reading >>

Choosing An Insulin Pump: Sticking With The Minimed Revel 723

Choosing An Insulin Pump: Sticking With The Minimed Revel 723

We're sorry, an error occurred. We are unable to collect your feedback at this time. However, your feedback is important to us. Please try again later. I'm the proud owner of a new insulin pump, the sixth one in my 13-year lineage of being an insulin pumper. For those curious, here's the list: a Minimed 508, followed by upgrades to the 512 and 715, a switch to the Deltec Cozmo, and return to the Minimed Paradigm 722. Now, this new Minimed Revel 723 (that list doesn't factor in all the models I've tried out, or the pump replacements needed through the years). You may remember that I've spent most of the past year preparing for a new insulin pump purchase and deciding what diabetes devices would be the best fit for me. As a longtime Medtronic Minimed insulin pumper since my final year of college in 2001, I've had nothing but good luck with those devices through the years. The last pump I had was the Minimed Paradigm 722, which is no longer made and ran of out warranty more than a year ago, so that's what I was looking to replace. You might think the latest and greatest Medtronic Minimed 530G would be my choice. But here's the thing: I am a Dexcom G4 (continuous glucose monitor) user, so the 530G with Enlite sensor isn't what I want. With the 530G getting approved in late September, the company made the bold policy decision to no longer sell stand-alone insulin pumps to most adult PWDs with commercial insurance. You'd be forced to buy the newest CGM-integrated pump, even if you didn't want to use that CGM. That turned me off of MedT almost completely, especially since I'd just bought a Dexcom a couple months before and wasn't about to return it. And it didn't help that people were saying the accuracy and real-world experiences weren't great with the integrated Medtronic d Continue reading >>

Medtronic (unomedical) Infusion Sets(2017-09-11)

Medtronic (unomedical) Infusion Sets(2017-09-11)

Medtronic (Unomedical) Infusion Sets(2017-09-11) General Public, Healthcare Professionals, Hospitals Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. The reported incidence rate requiring medical assistance related to this issue is less than 1 in every 2 million infusion sets. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Manufacturer investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid may occur if insulin, alcohol, or water is spilled on top of the insulin reservoir, which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. More than 10 numbers, contact manufacturer Continue reading >>

Newsroom | Medtronic | 2018 Press Releases

Newsroom | Medtronic | 2018 Press Releases

Medtronic to Unveil Additional Clinical Data on HVAD System at ISHLT 2018 Data on Implant Approach, Blood Pressure Management, Length of Stay, and Quality of Life to be Featured During Congress. DUBLIN - April 9, 2018 - Medtronic plc (NYSE: MDT) today announced a preview of notable clinical data on the HeartWare HVAD System that will be presented at The International Society of Heart and Lung Transplantation (ISHLT) Scientific Sessions, from April 11-14, 2018, in Nice, France. The HVAD System is a mechanical heart pump (also called a left ventricular assist device,... Medtronic Announces Renal Denervation Pivotal Trial for the Treatment of Hypertension Pivotal Trial Now Underway to Study Effect of Investigational Procedure in Patients with High Blood Pressure DUBLIN - April 9, 2018 - Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval to begin an investigational device exemption (IDE) pivotal trial to evaluate the Symplicity Spyral(TM) renal denervation system in patients with high blood pressure (hypertension). Renal denervation is a minimally invasive procedure intended to regulate the activity of nerv... Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics DUBLIN - April 5, 2018 - Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced Laura Mauri, M.D., M.Sc., interventional cardiologist and clinical researcher at the Brigham and Women's Hospital, and professor of medicine at Harvard Medical School, will join Medtronic as Vice President, Global Clinical Research & Analytics. Dr. Mauri will direct the company's dynamic global clinical research strategieswhich leverageher widely recognized clinical trial leadership and... New Analyses Confirm Patients with Medtronic Continue reading >>

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

Announcement Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost. Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with government and regulatory authorities on this global voluntary recall. "Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients," said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic. "Our Medtronic Diabetes team will work as quickly as possib Continue reading >>

Prescription Drugs - Medicare Information, Help, And Plan Enrollment - Medicare.com

Prescription Drugs - Medicare Information, Help, And Plan Enrollment - Medicare.com

Find potential savings on this prescription drug Drug information data provided by OpenFDA. OpenFDA is an initiative in the Office of Health Informatics (OHI) at the Food and Drug Administration led by the Chief Health Informatics Officer (CHIO). OpenFDA provides Application Programming Interfaces (APIs) and raw download access to a number of high-value, high priority and scalable structured datasets, including adverse events, drug product labeling, and recall enforcement reports. Privacy and Security Your privacy and security are extremely important to us. Your personal information is protected by our Privacy Policy. Our website is backed by certified internet security standards. The costs of Medicare plans are strongly regulated by the federal government. Any individual plan listed on our site carries the same costs and offers the exact same benefits regardless of whether you purchase it from our site, a government website, or your local insurance broker. Our commissions are paid by insurance carriers, so there is no additional cost to you, our consumer. Learn More To learn about Medicare plans you may be eligible for, you can: Call 1-800-MEDICARE (1-800-633-4227), TTY users 1-877-486-2048; 24 hours a day, 7 days a week. Contact a licensed insurance agency such as Medicare.com. Our licensed insurance agents are available at: Call Medicare.coms licensed sales agents: 1-844-847-2659 , TTY users 711; We are available Mon - Fri, 8am - 8pm ET Medicare.com is privately owned and operated by eHealthInsurance Services, Inc. Medicare.com is a non-government resource for those who depend on Medicare, providing Medicare information in a simple and straightforward way. If you're looking for the government's Medicare site, please navigate to www.medicare.gov . This website and it Continue reading >>

Medtronic Warns Of Stuck Minimed Pump Buttons

Medtronic Warns Of Stuck Minimed Pump Buttons

Changes in air pressure might cause an issue, the pump maker warns. Stuck insulin pump button on a plane! … sounds like a straight-to-video Samuel L. Jackson thriller, but it’s actually the gist of a safety notice issued by Medtronic for those who use its MiniMed pump systems. sponsor Medtronic issued a field safety notification about a rare, temporary, but still annoying glitch that can happen with MiniMed 600 series pumps. When atmospheric pressure around the pump increases or decreases rapidly, it can cause the keypads on the pumps to become stuck or difficult to push down. The notice states that if the button seems difficult to push down, it’s most likely a temporary situation which will usually resolve itself within 30 minutes. The bigger problem is when the pump button gets stuck in a pressed position. The pumps are designed to cut off insulin delivery (both bolus and basal) within three minutes of detecting such a problem, but this can cause a siren to go off if the situation isn’t resolved within 10 minutes, and insulin delivery won’t resume until you clear the alarm. To solve this, they suggest the elegantly low-tech solution of removing the pump’s battery cap and then installing it again. They warn, however, that you might need to have a AA battery handy, as the pump might decide then that it needs a new one. Medtronic is currently not suggesting that MiniMed pumps need to be recalled or repaired because of this issue. The Medtronic MiniMed 600 series includes the 630G, the 640G, and the 670G. Customers should already have received notice of this issue from Medtronic. This isn’t the first reported issue to arise with the MiniMed pump systems. Earlier this year, Medtronic warned that kinked cannulas could cause insulin delivery interruption in Min Continue reading >>

Medtronic Recalls Minimed Paradigm And 530g Systems Due To Hypoglycemia Concerns Resulting From Minor Device Design Error

Medtronic Recalls Minimed Paradigm And 530g Systems Due To Hypoglycemia Concerns Resulting From Minor Device Design Error

Twitter summary: Medtronic recalls MiniMed products due to minor design error leading to accidental hypo – new design in the works to fix the issue On August 22, the FDA posted a voluntary class II recall of Medtronic MiniMed Paradigm and 530G systems. There are three levels of FDA recalls (class I, II, and III), with a class II recall indicating an intermediate threat level, for those that can pose some health risks that are typically preventable and are not cause for major alarm. In this case, Medtronic mailed notices to customers earlier this year about the risk of an accidental overdose of insulin. Evidently, scrolling down past “zero” on the insulin dosing screen immediately scrolled to the maximum bolus dose of insulin, allowing users to accidentally give much more insulin than intended (e.g., hitting the down arrow once would scroll from 0.0 units to 10.0 units). Reports of this serious error have fortunately been rare, with only one reported instance of severe hypoglycemia resulting in hospitalization. Medtronic already wrote its customers in March describing the issue and what safety precautions should be taken to minimize this hypoglycemia risk, and with this recall they plan to change the design such that the scrolling feature stops at zero. The FDA announcement said that 559,374 Paradigm and 530G systems had been recalled to date, impacting all Medtronic customers. Those who have Medtronic pumps do not need to return their pumps, but should read the safety information posted here. -AJW Whether you have type 2 diabetes, are a caregiver or loved one of a person with type 2 diabetes, or just want to learn more, the following page provides an overview of type 2 diabetes. New to type 2 diabetes? Check out “Starting Point: Type 2 Diabetes Basics” below, Continue reading >>

Newsroom | Medtronic | 2018 Press Releases

Newsroom | Medtronic | 2018 Press Releases

New Analyses Confirm Patients with Medtronic CRT Devices Experience Less Atrial Fibrillation, Are More Active Positive Data on Exclusive AdaptivCRT(TM) Feature Unveiled at EHRA Scientific Sessions 2018 DUBLIN and BARCELONA, Spain - March 20, 2018 - Two real-world analyses featuring the Medtronic plc (NYSE: MDT) AdaptivCRT(TM) algorithm reinforce that its use is linked to a reduction in atrial fibrillation (AF) episodes, as well as tied to higher patient activity levels. The results, involving 408 patients with heart failure and a Medtronic cardiac resynchronization therapy (CRT) device at 26 centers i... Study Shows Positive Results with Medtronic Cryoballoon for Patients with Persistent Atrial Fibrillation DUBLIN and BARCELONA, Spain - MARCH 19, 2018 - Medtronicplc (NYSE: MDT) today announced one-year results from the CRYO4PERSISTENT AF study of ablation with the Arctic Front Advance(TM) Cryoballoon to isolate the pulmonary veins in patients with symptomatic persistent atrial fibrillation (AF). The Arctic Front Advance Cyroablation System is not approved for treating persistent AF in the United States. The study results, presented today at the European Heart Rhythm Association (EHRA) Scientific ... Medtronic EVP & President Hooman Hakami to Speak at Oppenheimer Healthcare Conference DUBLIN - March 13, 2018 - Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it will participate in the Oppenheimer 28th Annual Healthcare Conference on Tuesday, March 20, 2018, in New York City. Hooman Hakami, executive vice president and group president of Medtronic's Diabetes Group, will answer questions about the company beginning at 8:35 a.m. EDT (7:35 a.m. CDT). A live audio webcast of the presentation will be available on March 20, 2018, by clicking o Continue reading >>

Medtronic Infusion Device Recall: No Reason To Panic

Medtronic Infusion Device Recall: No Reason To Panic

Medtronic Infusion Device Recall: No Reason to Panic Medtronic Infusion Device Recall: No Reason to Panic Last month, Medtronic announced a voluntary recall/replacement for many of their popular Paradigm infusion devices, including the Mio, Quick Set, and Silhouette. Interestingly, the problem is not with the tubing or the infusion set itself it is with the connector that attaches the tubing to the insulin reservoir. This piece, called a P-Cap, contains a vent that allows pressure within the reservoir to remain consistent with outside air pressure. If this vent become clogged, pressure within the reservoir can exceed outside air pressure, and can result in unintended movement of insulin out of the reservoir, through the tubing and infusion set, and into the users body. And we all know where that can lead. The potential for vent clogging has existed since Paradigm-compatible infusion devices were first developed. The problem came to a head with the advent of the 630G and 670G pumps, which are deemed water-tight by the manufacturer. With more people wearing their pumps in the water, the potential for clogging has increased but only if the P-Cap is not attached properly to the reservoir. When attached properly, the vents membrane is sealed from exposure to moisture, so clogs dont take place. If the P-Cap is attached improperly (i.e. at a bent angle to the reservoir), insulin can leak out and block the vent, and water from pump submersion can also block the vent. The incidence of reported problems related to the P-Cap has been very rare (1-2 per million infusion sets). Nevertheless, Medtronic redesigned the P-Cap to eliminate the problem and is offering to replace older infusion devices with new ones, free of charge. Does this mean that you should not use the older infusio Continue reading >>

Minimed Pump Recall

Minimed Pump Recall

D.D. Family T1 for 72 years, here to help Minimed is recalling many pumps because of damage being done to them by an MRI. Some people arre actually using them after they are damaged and the pump is then delivering more than it is supposed to and this could cause serious hypos. Here is the site: Friend T1 Since 1987, pumping with a Minimed 722 Holy Smokes!!! Thanks for the link. I don't need to send mine back as far as I know, because I have not had an x-ray, or MRI, or anything of that sort since having mine. How scary though. eeek. I'm pretty sure I got a letter from minimed about this. I feel like it was awhile back....maybe not? Now I'm thinking I'm just crazy...... Friend T1 Since 1987, pumping with a Minimed 722 No, you're not crazy. I got the same letter. I just did not know they were recalling them. Does this mean we all have to send ours back? Or only those of us that have been around MRIs? I think just those around MRI's. And if you do get an MRI, take off your pump! I'm pretty sure I got a letter from minimed about this. I feel like it was awhile back....maybe not? Now I'm thinking I'm just crazy...... i read something from ?medline? pubmed? that minimed was replacing pumps that some people had worn into the MRI machine! the magnetic imaging interfers with the pumps 'brain' these people really are quite lucky that minimed is replacing their pumps for them........ read that manual?? How scary! I never received a letter from MM.... But I haven't had an MRI, so I won't worry. Friend T1 Since 1987, pumping with a Minimed 722 I think just those around MRI's. And if you do get an MRI, take off your pump! Yeah, thats what I was thinking. I got the letter a while back, and it did not say anything about returning my pump. I am just wondering if they have found a way t Continue reading >>

Fda Recall Notice Issued For Nearly 2,000 Medtronic Minimed Insulin Pumps

Fda Recall Notice Issued For Nearly 2,000 Medtronic Minimed Insulin Pumps

Medtronic ($MDT) disclosed difficulties with almost 2,000 units of its latest model insulin pump, the MiniMed 640G, which had been distributed in 10 European countries, according to a recall notice just issued by the FDA. This model had its European launch in January and is slated for a PMA submission later this year. The reported problem, which the FDA classified a Class 2 recall--meaning that it can cause reversible adverse health consequences--is that the system does not time out when the screen is set for a bolus insulin delivery. That can cause confusion for patients, because the bolus amount is no longer accurate. The ability to suspend and then restart insulin delivery levels automatically based on sensor glucose levels is supposed to be the advantage of the MiniMed 640G and marks a step toward an artificial pancreas that can automatically regulate relevant hormones for diabetics. Medtronic originally sent a letter to its customers notifying them of the inaccurate bolus screen problem on June 19. It has not requested the devices be returned. Rather, customers were advised to respond promptly to bolus screens and to not activate bolus insulin delivery based on a blood glucose value that's more than 12 minutes old. Specifically, the recall notice was for 1,936 units across Australia, Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden and the United Kingdom. Diabetes is a relatively small but fast-growing space for Medtronic, which reported $467 million in revenues from the group last quarter--an increase of 8%. That's better than the 7% overall revenue growth rate for its total of $7.3 billion in revenues. MiniMed is at the core of the device giant's diabetes push--both the EU adoption of the 640G, as well as preparation for a U.S. r Continue reading >>

Medtronic Launches Minimed 630g In U.s.

Medtronic Launches Minimed 630g In U.s.

Medtronic (NYSE:MDT) announced the U.S. launch of the MiniMed 630G insulin management system it developed to work with a blood glucose meter made by Ascensia Diabetes Care. The MiniMed 630G uses Medtronic’s SmartGuard software and a continuous glucose monitor to warn patients when glucose levels reach a preset low and to cease insulin delivery if the user doesn’t respond to the alarm, the Fridley, Minn.-based company said. Medtronic debuted the SmartGuard tech when it won pre-market approval for the MiniMed 530G system (the company has also reportedly filed for pre-market approval from the FDA for its MiniMed 670G “artificial pancreas”). The MiniMed 630G is also designed to link wirelessly to Ascensia’s ContourNext Link 2.4 finger-prick blood glucose meter, which can calculate and remotely deliver bolus doses and calibrate the CGM sensor. The duo re-upped their 5-year partnership in June. Ascensia was formed in January through the sale of Bayer‘s (ETR:BAYN) Diabetes Care biz toPanasonic (NYSE:PC). “This latest innovation demonstrates Medtronic’s vision to transform diabetes care to enable greater freedom and better health through a commitment to continually improving both outcomes and user experience,” intensive insulin management president Alejandro Galindo said in prepared remarks. “Low blood sugar at night is of particular concern, when up to 75% of severe hypoglycemia occurs and patients are unlikely to be aware of symptoms while they are asleep,” added Dr. Satish Garg of the University of Colorado’s Barbara Davis Center for Childhood Diabetes. “The ability to automate the suspension of insulin at night is an important feature as prolonged hypoglycemia could be life-threatening.” In a separate release, Ascensia Diabetes Care U.S. presiden Continue reading >>

Review: Medtronic’s Minimed 630g Insulin Pump

Review: Medtronic’s Minimed 630g Insulin Pump

I have used the Minimed 630G Insulin Pump System by Medtronic for the past 30 days. This review is my opinion of the pump, both positive and negative. I have used insulin pumps since I got my first Disetronic H-Tron V-100 in 1994. I got a Minimed 506 pump in 1998 and have been a fan of the Minimed/Medtronic pumps since. Until now. Minimed 630G Insulin Pump System The Minimed 630G Insulin Pump System comes with the pump, the CGM transmitter, and a Contour Next Link 2.4 blood glucose meter. The three devices work well together, once set up right. Medtronic also has an early access program. This lets you buy the Minimed 630G now, and upgrade to the upcoming Minimed 670G in spring of 2017. Receiving the Pump The 630G Pump comes in several boxes. The pump comes in an 8″x10″x2.25″ box that has the pump and several small items like clips, batteries, a manual, and a quick start guide. Another box of the same size has the Contour Next Link 2.4 meter. A second box arrived a few days later with the infusion sets and reservoirs, followed by another box a few days later with the CGM sensors. I got another box a week later with the CGM transmitter. In the past, the local Medtronic trainer would call me to train me on using the pump, with a request not to use it before the training. I normally ignore this request, since I have used Minimed pumps for so long. I do go to these trainings every once in a while, but I was never contact this time. Unusual, considering how new this version of the pump is. Even so, the pump was fairly easy to set up. I also got a pile of 8.5″x11″ manuals. One was a “previous pump users manual” and one was a “pump users manual’. There was a large manual in the box that had everything in it. And another “how to use the CGM” manual. Quite d Continue reading >>

Medtronic Minimed Infusion Sets

Medtronic Minimed Infusion Sets

URGENT MEDICAL DEVICE RECALL INFORMATION Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps. Explanation of the Issue Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. Actions Required by You Go to to determine if you have recalled infusion sets. You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not. Your REF and LOT numbers are listed on the labels as shown in the examples below: If you have new and enhanced infusion sets that are not part of this recall, use only those sets starting with your next set change. As a reminder, we have Key Steps regarding the priming/fill-tubing process. If you only have recalled infusion sets right now, it is very important that you carefully follow the Key Steps. Return your recalled infusion sets within the next four weeks the pre-paid label that has been sent to you. Medtronic will replace the recalled infu Continue reading >>

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