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Medtronic Letter

Chairman's News | Newsroom | The United States Senate Committee On Finance

Chairman's News | Newsroom | The United States Senate Committee On Finance

Baucus, Grassley Question Medtronic about Unreported Side Effects, Financial Ties to Clinical Investigators Finance Leaders Begin Investigation Into Medtronic Infuse Trials Washington, DC Senate Finance Committee Chairman Max Baucus (D-Mont.) and senior Committee member Chuck Grassley (R-Iowa) asked medical device manufacturer Medtronic on Tuesday to produce documents related to its controversial bone growth product Infuse. In a letter sent to Medtronic, the Committee raised concerns over recent media reports that indicate medical researchers in charge of Infuse clinical trials may have been aware of and failed to report evidence that the product may cause sterility in men and potentially-harmful bone growth. The letter also notes many of these investigators had substantial financial ties to the device manufacturer. These reports that doctors conducting medical trials while on Medtronics payroll may have hidden serious side effects for patients are deeply troubling, said Senate Finance Committee Chairman Baucus. Information is one of the most important tools patients and doctors have when making medical decisions. Patients have a right to know the risks associated with their treatments, and medical device companies have a duty to disclose this information. We need to do everything we can to ensure companies arent concealing serious medical complications from patients just to increase profits. A patient having surgery has to rely on his doctors knowing the risks and benefits of a medical device. The doctor in turn has to rely on the medical literature. If the medical literature has been written by those with financial ties to the device maker, the doctor and his patient should know that. A lack of transparency leaves doctors and patients in the dark on something any of Continue reading >>

Fda: Medtronic Must Stop Most Sales Of Synchromed Drug Pumps

Fda: Medtronic Must Stop Most Sales Of Synchromed Drug Pumps

FDA: Medtronic must stop most sales of Synchromed drug pumps says Medtronic must stop most sales of its implantable drug pumps after years of uncorrected problems. The FDA has filed a court order against Medtronic that says the medical device giant must halt most production and distribution of its Synchromed II drug pumps, which are implanted devices used to treat patients with cancer, chronic pain and severe muscle spasms. Among other defects, some Synchromed pumps had to be recalled because they could lose battery power and fail, endangering patients. In other cases, the devices could cause patients to receive too much or too little medication. Medtronic generally did not recommend that patients have the devices removed, unless they were proven to be failing. The devices are surgically implanted and deliver a drug solution to the area surrounding the spinal cord. They are prescribed for patients who do not respond to oral medications or who experience severe side effects when taking them. Medtronic said the agreement allows the company to make some drug pumps available on a limited basis to physicians. The Minneapolis-based company stressed it is not announcing any new recalls or safety alerts about its products. "Patients with the Synchromed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement," Medtronic said in a statement. The FDA's consent decree was filed in the U.S. District Court of Minnesota and awaits the signature of a federal judge. The government says that Medtronic CEO Omar Ishrak and neuromodulation business chief Thomas Tefft sold medical devices that failed to meet federal manufacturing standards, enforced under the Food, Drug and Cosmetic Act. A cons Continue reading >>

In Letter To Franken, Fda Defends Handling Of Medtronic's Infuse Study

In Letter To Franken, Fda Defends Handling Of Medtronic's Infuse Study

The U.S. Food and Drug Administration is defending a decision to accept more than 1,000 patient injury reports from Medtronic in summary form, years after they were supposed to be submitted. The FDA responded earlier this month to questions from U.S. Sen. Al Franken of Minnesota by saying it took no action against Medtronic for the late reporting of a study of its Infuse bone graft because the information was consistent with data the agency already had. Franken had inquired after the Star Tribune recently reported about the study, which Medtronic shut down in 2008 without reporting injuries it had found. The FDA didnt get the study data until 2013, though federal law requires companies to report injuries within 30 days of discovering them. The revelation of the lost study followed years of questions about how forthcoming Medtronic has been about Infuse, a product that has brought in billions of dollars in sales while attracting multiple government investigations and thousands of patient injury claims. After receiving the FDAs response to his questions, Franken says the handling of Medtronics Infuse study signals a broader need to change how the agency safeguards the publics health. He called for a more robust, proactive medical device surveillance system to avoid potentially dangerous reporting errors. Medtronic says failure to report Infuse data was unintentional While the agencys response provided some valuable information about the process that FDA and Medtronic undertook once the company came forward with the new adverse event information, I remain concerned that the FDA did not disclose patient injury data in either a timely or a transparent fashion, Franken told the Star Tribune. In the FDAs response to Franken, Acting Associate Commissioner for Legislation Dayle Continue reading >>

Senator Grills Medtronic, Fda Over Alleged Mishandling Of Infuse Bone Graft Study Data

Senator Grills Medtronic, Fda Over Alleged Mishandling Of Infuse Bone Graft Study Data

Senator grills Medtronic, FDA over alleged mishandling of Infuse bone graft study data Medtronic ($MDT) has taken some responsibility for mishandling data from a retrospective chart review of its bone graft, Infuse, after a recent report said that the company allegedly buried side effect reports linked to the product. But Medtronic's response did not appease one lawmaker, who is calling on the company and regulators for more answers. Sen. Al Franken (D-MN) in letters to Medtronic CEO Omar Ishrak and FDA Commissioner Robert Califf said that he was "writing out of concern" after the Star Tribune published a story recently saying that Medtronic waited 5 years before reporting serious adverse events to the FDA. "This lack of information potentially skewed the risk profile of the device, which may have affected the treatment of thousands of patients," Franken said in both letters. And the Star Tribune story "raises troubling questions about the FDA's insufficient vigilance in its industry watchdog role." In 2008, Medtronic shut down a study of Infuse that looked at the medical records of 3,647 patients at 26 sites who got the graft. Some of the records showed more than 1,000 complications, and a portion of those were linked to Infuse. Employees running the study filed the data in the company's internal archives and did not report the data until 2013, after reports of complications with Infuse surfaced. Now, the company and the FDA are coming under fire for their roles in the buried data. The FDA let the company file a summary instead a of a detailed report for the remaining adverse events because the information "was dated" and "didn't reflect new public health concerns," an FDA spokesman told the Star Tribune in an email. And Medtronic said that the reporting delay didn't Continue reading >>

Fda Warns Medtronic's Tyrx On Anti-bacterial Envelopes - Massdevice

Fda Warns Medtronic's Tyrx On Anti-bacterial Envelopes - Massdevice

Early Rates for DeviceTalks Minnesota end this week If you're thinking about joining us at DeviceTalks in the Twin Cities June 4-5 , now would be a great time to register, as this is the last week that you can take advantage of our early savings rate and save more than $100 on the cost of registration. Take a look at our schedule to see howDeviceTalkshas evolved into a must-attend event for all members of the medtech community. Whether you're building a medical device or leading a medical device company, we have the right content for you. How a new MRI technique is improving patient comfort Researchers at Cedars-Sinai in Los Angeles have created a new technique for administering magnetic resonance imaging tests that helps patients be more comfortable and decreases testing time while increasing accuracy and reliability. The new test is called MR Multitasking and tackles a common problem cardiologists face which is getting a still image when the heart [] This sensor attaches to the tooth and tracks dietary intake Scientists in Massachusetts have developed a tiny sensor that fits on the surface of a tooth and tracks dietary intake. Tuft University School of Engineering researchers created a sensor that communicates wirelessly with a mobile device. It transmits information regarding glucose, salt and alcohol intake, which the researchers suggest could help detect and record a [] Aranz Medical launches two new image capture products Aranz Medical (Christchurch, New Zealand) has launched its two new smartphone-based imaging products in a multi-site clinical trial through Promore Pharma and in New Zealands Capital and Coast Digital Health Board. The new imaging apps SilhouetteLite+ and SilhouetteLite are portable and easy-to-use. They deliver accuracy and image consistent and Continue reading >>

Letter From Pew And Medtronic To Hhs Regarding The Physician Payments Sunshine Act

Letter From Pew And Medtronic To Hhs Regarding The Physician Payments Sunshine Act

Letter From Pew and Medtronic to HHS Regarding the Physician Payments Sunshine Act Acting Administrator, Centers for Medicare & Medicaid Services U.S. Department of HeaLth and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 We are writing to urge you to fully implement Section ll28G of the Social Security Act, the PhysicianPayments Sunshine Provision, which was added as Section 6002 of the Patient Protection and Affordable Care Act (PPACA). This provisionrequires that manufacturers of drugs, devices,biologics or medical supplies, or their subsidiaries that sell these products in the United States,reportto Healthand Human Services (HHS)certain payments madeto physicians and teaching hospitals. It reflects the recommendation by major medical, consumer and industry groups, as well as MedPAC and the Institute of Medicine,that Congress pass federal legislationto bring transparencyto the financialrelationships between pharmaceutical and medical device companies,and health professionalsand teaching hospitals. This federal transparency provisionhas support from diversestakeholders, includingconsumerand patient groups, professional medical associations, provider organizations, and industry. As you move forwardto implementthis provision,we ask you to work quickly. The legislation required HHS to establish,by October l, 2011, reporting proceduresfor applicable manufacturers to submit informationto you, as well as procedures for making such information available to the public. Over one year later, these final regulations have not yet been released. Many companies have alreadyinvestedsignificant resourcesin preparingto complywith the Sunshineprovision. The originalstatute required covered entities to begin collecting payment information as of January 1, 2012, an Continue reading >>

Medtronic Cover Letter | Internship | Software Engineer

Medtronic Cover Letter | Internship | Software Engineer

Sample cover letter for Internship position at Medtronic Looking for a dynamic learning college student whose knowledge is constantly developing in computer science applications? I seek a highly collaborative, goal oriented professional work environment that can demonstrate engineering principles in a learn-by-doing setting on real life projects. When developing technology that is used to save lives, you need developers who understand the critical importance of producing a high quality product. Medtronic has established itself as one of the leaders in technology and innovation by setting the bar high and demanding progress. Producing such products start with engineers who set the bar high and demand improvement. I possess the work ethic required to be an asset to Medtronic. I am willing to learn from others, study the foundation this company has established, and provide my best effort to learn quickly and be a productive part of the team at Medtronic. Having a lot to offer to your company is not my only reason for wanting to work for it. I know Medtronic can offer immeasurable experience to me as a programmer and engineer. I want to work in an environment that challenges me to continue learning, whether it is the fast-paced evolution of technology or just software I am not familiar with. Working in a workplace where the staff alone can provide tremendous knowledge and resources is a great opportunity for any engineer. I can assure you my interest in computer software and engineering applications will reflect my performance and will exceed expectations. I need a company that is a technology and innovation leader, a company like Medtronic is what I need to become an innovative engineer. See our template for making your own punchy cover letter Get access to over 7,000 cov 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 >>

Medtronic: Certain Stent Grafts May Confuse During Implantation

Medtronic: Certain Stent Grafts May Confuse During Implantation

Medtronic: Certain stent grafts may confuse during implantation Some Endurant and Endurant II bifurcated stent graft systems could fool doctors into thinking a more serious endoleak is taking place during the implant procedure, causing the doctors to take unnecessary extra interventions, Medtronic is warning in a letter to health providers published in Europe. The voluntary recall announcement , posted today on the website of Germanys Federal Institute for Drugs and Medical Devices ( BfArM ), tells health providers to identify and return the Endurant and Endurant II stents covered in the recall that are still in inventory. Since potential problems take place during implanting, the recall doesnt cover stents already implanted inside people.Patients who have been implanted with an EndurantEndurant II 23mm or 25mm bifurcated stent graft system affected by this recall do not require any additional follow up due to this observation and should continue to be monitored in accordance with standard practice, Medtronic spokesperson Krystin Hayward said when contacted by MDO.And FDA spokesperson said the agency was in communication with Medtronic about the recall but did not presently have additional information to share.Medtronic in the letter says it received 20 complaints between May 2015 and January 2017 of health providers taking additional interventions during procedures because they mistakenly thought a patient had an acute Type III Fabric endoleak. There have been two cases of adverse events. One person died three weeks after the implantation procedure, though it was inconclusive whether the secondary procedure caused the death. The potential flaw in the stent graft systems involves a permeability variation that could cause a doctor to mistakenly categorize a Type IV endo Continue reading >>

Medtronic | Medtronic | Medtech[y] Message Boards

Medtronic | Medtronic | Medtech[y] Message Boards

Terrible. So sorry. What role were you in that you had to train replacements in the Philippines? I would think if you were laid off to be replaced with cheaper labor then Medtronic had to give you a package....? Either way GIS is turning into a nightmare. Terrible. So sorry. What role were you in that you had to train replacements in the Philippines? I would think if you were laid off to be replaced with cheaper labor then Medtronic had to give you a package....? Either way GIS is turning into a nightmare. Why do people have to corrupt the site with this type of trash. There are so many scumbags that are haters out here because of nothing more than pure jealousy. If you are not happy with yourself, get help. If you are not happy with someone else, ignore them. If you know they have wronged or hurt someone or have participated in illegal conduct, report their sorry asses to the FDA and DOJ and/or their department of labor. Why do people have to corrupt the site with this type of trash. There are so many scumbags that are haters out here because of nothing more than pure jealousy. If you are not happy with yourself, get help. If you are not happy with someone else, ignore them. If you know they have wronged or hurt someone or have participated in illegal conduct, report their sorry asses to the FDA and DOJ and/or their department of labor. Continue reading >>

Senators Look Into Medtronic, Doctors

Senators Look Into Medtronic, Doctors

The Senate Finance Committee is investigating whether surgeons who received large sums of money from medical-device giant Medtronic Inc. for consulting and other work failed to note complications associated with a Medtronic bone-growth protein that has become widely used in spinal surgery. The inquiry was triggered in part by an upcoming study in a medical journal showing that numerous complications associated with the product, Infuse Bone Graft, occurred in clinical trials of the product but went unreported in a dozen... Copyright 2018 Dow Jones & Company , Inc. All Rights Reserved.

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  • Medtronic Receives Fda Warning Letter Over Cardiac Rhythm Facility

    Medtronic Receives Fda Warning Letter Over Cardiac Rhythm Facility

    Medtronic receives FDA warning letter over cardiac rhythm facility November 19, 2009 | Justine Varieur Cadet The FDA has sent Medtronic a warning letter, regarding the inspection of the companys cardiac rhythm disease management facility in Mounds View, Minn., which was completed in August. The agency observed four areas of concern, including corrective and preventive action and field action timeliness; review and documentation of field action recommendations; supplier qualifications and controls; and medical device reporting timeliness. The Minneapolis-based company will respond to the letter within 15 days, as required. Medtronic also said that it has already begun to implement changes and put procedures in place related to each of the observations cited during the inspection, and any additional actions that may be required will be in place as quickly as possible. The FDA noted in its warning letter that Medtronics promised corrective actions appear to be adequate to address the concerns raised in the letter, and will be confirmed upon re-inspection. Medtronic is working with FDA to resolve all remaining issues as quickly as possible, said Pat Mackin, president of the cardiac rhythm disease management business and senior vice president at Medtronic. Continue reading >>

    Medtronic Diabetes Insulin Pump Airport Security Letter

    Medtronic Diabetes Insulin Pump Airport Security Letter

    Medtronic Diabetes insulin pump airport security letter Medtronic Diabetes insulin pump airport security letter When travelling by plane you may wish to take a copy of the following Medtronic Diabetes insulin pump airport security letter with you to show at security. This person is wearing a Medtronic insulin pump and may be carrying a spare/loan. The device is not suitable to be worn during a Full Body Scan and therefore the patient requests an alternative screening process. This device can withstand exposure to common electrostatic (ESD) and electromagnetic interference (EMI), including typical airport security metal detectors. During exposure, it can remain connected and powered on. Do not expose to XRAY devices such as hand baggage scanners or other devices that generate very strong magnetic fields. The magnetic fields in the immediate vicinity of these devices can damage the part of the pumps motor that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia. If you have any questions concerning this device, please call the Product Support 24hr Helpline on 0044 (0)1923 205 167 (option 2). Continue reading >>

    News: Roche Hands Over Remaining U.s. Insulin Pump Customers To Medtronic

    News: Roche Hands Over Remaining U.s. Insulin Pump Customers To Medtronic

    Seven months after Roche Diabetes Care announced it would stop selling its Accu-Chek brand insulin pumps in the U.S., the company is now handing off its remaining pump customers to Medtronic Diabetes. Starting in September, any existing Roche pump customers who wish to continue using their Accu-Chek Spirit or Combo systems will start automatically receiving their supplies directly from Medtronic, unless they opt out of that service by the end of August. We're told this Acc-Chek support contract runs through Feb. 2021, which is the clearest sign yet that Roche Diabetes Care has no interest in bringing its insulin pump products back to the American market after it stopped selling them here at the start of 2017. A letter dated Aug. 3 that went out to Roche pump customers explains that these PWDs (people with diabetes) "have the right to the product of your choice" and includes a 1-800 number and email address for customers to opt out by Aug. 30 if they wish. Roche and Medtronic both tell us this is simply a way to ensure continued support for Accu-Chek pump customers until their products go off warranty; spokespeople for both companies declined to say how many people are impacted. What does this mean? To be clear, this does not mean that former Roche customers are being forced to switch to Medtronic pumps. They will simply be receiving Accu-Chek supplies from Medtronic if they don't opt out, meaning they will become part of that company's database of customers. Those who opt out are welcome to find a different third-party supplier to get their needed pump supplies (for example, Total Diabetes Supply online). Is the idea to 'onboard' these customers to Medtronic pumps over time? Not officially, we're told. Medtronic tells us they won't be offering any special upgrades or tr Continue reading >>

    Customers In Countries Outside U.s. And Canada

    Customers In Countries Outside U.s. And Canada

    Animas Corporation intends to exit the insulin pump business and discontinue the manufacturing and sale of Animas® Vibe® and OneTouch Ping® insulin pumps. This decision was extremely difficult and comes following an extensive exploration of all viable other options for the Animas business. We have selected Medtronic as our partner-of-choice to facilitate a seamless insulin delivery system transition period. One of the reasons we chose Medtronic as our partner-of-choice is because of its strong track record providing outstanding patient care and support. For over 30 years, Medtronic has been a global leader in the treatment of those living with diabetes, and we are confident that they will provide outstanding support to our patients and their care teams. If you are currently using an Animas pump and pump supplies, you will continue to receive pump support and services. Specifically, Animas will continue to provide customer service and warranty support, including providing pump supplies that are used in conjunction with the Animas® Vibe® and OneTouch Ping® insulin pumps, through a transition period. As part of our continued commitment to patient care, Animas will honor pump warranties. We recognize that patients living with diabetes rely on our products to provide critical care, and we want to reassure patients and their care teams that we will be there, every step of the way, throughout this process. For patients, caregivers and healthcare providers in the U.S. and Canada, this announcement means: Animas has discontinued the sale of all Animas® Vibe® and OneTouch Ping® insulin pumps effective immediately. If you are on a pump with a warranty that expires on or after September 30, 2019, you or your pump supplier will be contacted by a member of the Medtronic tran Continue reading >>

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