Medtronic Letter

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 >>

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 >>

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 Announces Voluntary Recall Of Diabetes Infusion Sets

Medtronic Announces Voluntary Recall of Diabetes Infusion Sets DUBLIN - September 11, 2017 - 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 Diabe Continue reading >>

Important Patient Safety Information - Physician Letter: Concerto Crt-d And Virtuoso Icd Device Longevity

Medtronic is advising you about a subset of an estimated 6,300 active implanted Concerto CRT-D and Virtuoso ICD devices worldwide that may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation.This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionality or affect therapy delivery.Medtronic has received no reports of death or injury attributed to this issue. Based on information from returned devices, Medtronic expects that affected devices will continue to provide at least three months of normal device function between RRT and End of Service (EOS) as described in device labeling. As a part of ongoing returned product analysis, Medtronic has confirmed 230 units have exhibited this capacitor degradation. Concerto and Virtuoso devices in the affected subset were manufactured primarily in 2006 and can be traced to a specific subset of low voltage capacitors.To date, there have been no related confirmed failures in Concerto and Virtuoso devices outside of this subset, including devices that were manufactured during the same time. After consultation with Medtronics Independent Physician Quality Panel, Medtronic offers the following recommendations for patients with devices in the affected subset: Physicians should continue routine follow-up sessions at least every three months in accordance with product labeling. Physicians should verify that the Low Battery Voltage RRT alert is programmed to On-High. This provides an audible, alternating tone when the device reaches RRT.These devices are shipped with this alert programmed nominally to On-High. Physicians may consider monitoring patients through Ca 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 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 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 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 >>

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 Scrambles To Fill Orders After Glitch Knocks Computer System Offline

Medtronic scrambles to fill orders after glitch knocks computer system offline Managing Editor, Minneapolis / St. Paul Business Journal A global computer outage has struck Medtronic, affecting order-taking and manufacturing at the med-tech giant. The Star Tribune reports on the problem , which apparently struck Medtronic (NYSE: MDT) earlier this week. By Thursday, a spokesman said, Medtronic had restored its "fundamental system" and was bringing it back online. CEO Omar Ishrak , in a letter to employees this week, said that Medtronic was facing a "temporary global outage of our foundational information technology systems," which are used to fulfill orders and manufacturing products. He said the problem seemed to be an internal matter, adding, "We have no indication that an outside agent is involved." Employees at the company, which is legally based in Dublin, Ireland, but has its operational headquarters in Fridley, are working extra hours to ensure that orders are processed correctly. Medtronic enacted contingency plans to ensure that critical patient needs were met, but customer orders could still face delays going forward as the company gets caught up. It's not clear how big an impact the outage could have on sales, though the spokesman said Medtronic didn't believe it would be material to its revenue and earnings. There have been several high-profile incidents of computer failures among big companies in the past year, though most were only noticed because of widespread public impact: problems at Southwest Airlines and Delta Air Lines Inc. last summer , for example, or the worldwide disruption of Bloomberg terminals in 2015 . Glitches in manufacturing operations, in contrast, are often only noticed by the company and its immediate clients, unless the disruption is a Continue reading >>

Medtronic Minimed 9/19/13

Department of Health and Human Services Public Health Service Food and Drug Administration WARNING LETTER VIA UNITED PARCEL SERVICE Continuous Improvement Request (CIR) CIR#D08-012 (opened 12/23/2008) and CIR#G08-009 (opened 12/23/2008) were opened to address data taken from process audit results from 2006-2009 that showed that process validation procedures and policies were not followed (this appears to affect all product lines). The root cause was identified as insufficient training and lack of attention to detail. As a corrective action, training of personnel was completed (3/21/2009). There is no documentation in the record to verify or validate that training as a corrective action was effective and would prevent recurrence of your employees not following process validation procedures and policies (Master validation procedure SOP 109-12); the CAPAs were closed on 04/27/09. CIR#E-08-008 (opened 09/15/2008) was opened to address (b)(4) periodically seen in device verification testing and during the qualification tests on Paradigm Insulin Infusion Pumps which could cause (b)(4). The CAPA was closed on 7/10/09 recommending implementation of a (b)(4) test to be performed on (b)(4) on a (b)(4) basis as a periodic check to provide assurance that process stability and capability are maintained. No verification or validation documents were found in the CAPA file to document that the effectiveness of this corrective action (conducting (b)(4) tests on (b)(4)) identified in CAPA CIR#E-08-008 was assessed and that this corrective action identified was implemented. Mr. Henry Sanders, the firm’s Director of Pump Value Stream, stated that (b)(4) test was performed as required. Quality Improvement Request (QIR) QIR#08-002 (opened 04/15/2008) was opened to address failure analysis Continue reading >>

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 >>

Letter Of The Week: Mother Caught Between Medtronic And Bluecross Blueshield Refuses To Give Up

Letter of the Week: Mother Caught Between Medtronic and BlueCross BlueShield Refuses to Give Up After reading the story in the April/May Diabetes Health about the mother and daughter who won approval from Blue Cross/Blue Shield to pay for the continuous monitor, I wanted to share our story. Our daughter was diagnosed with type 1 in April 2002. Jae had problems regulating her blood sugars for many years, had seizures, and missed a good share of her senior year of high school due to health issues. She also has polycystic ovarian syndrome and endometriosis. In November 2006, we purchased Medtronics continuous blood glucose monitoring system for her, as she had been an insulin pump user since November 2002. At the time of purchasing the CBGM System, we were informed by Medtronic that it would be our responsibility to work with BCBS to pay for the sensors. Medtronic claimed that they did not yet have a billing number to submit to BCBS for the sensors. In January 2007, I started the appeal process with BCBS of Minnesota to cover the ongoing sensors needed for the CBGM system. Jae was wearing them daily and thought they were great. She thanked us many times for getting them for her and told us we didnt need to buy her any Christmas presents in 2006 because not having to test so many times a day was a Christmas present all in itself! Jae was going through about 10 sensors a month. Thankfully, my husband and I have been fortunate enough to be able to pay for the sensors without insurance assistance. I ended up having to file an appeal/request with BCBS three times until finally, in February 2008 (14 months after our initial request), thanks to a very determined and caring customer service liaison at BCBS, the sensors were approved for coverage under Jaes insurance. BCBS denied Continue reading >>

The Use Of Non-medtronic Devices With Medtronics Navlock Tracker Letter To Health Care Providers

The Use of Non-Medtronic Devices with Medtronics NavLock Tracker Letter to Health Care Providers The FDA is providing information related to adverse events reported during or following procedures that involved the use of non-Medtronic surgical stereotaxic navigation instruments with Medtronic's NavLock Tracker. Medtronics NavLock Tracker, an accessory to Medtronic's StealthStation Surgical Navigation System, enables navigation of instrumentation used during spinal fusion and interbody procedures. On May 1, 2017, Medtronic issued a communication to consumers related to the use of non-Medtronic instruments with Medtronic's NavLock Tracker. This notice reports that Medtronic is aware of occurrences of minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic's NavLock Tracker. As a result, Medtronic notified the Agency of plans to update its product labeling to clarify the use of non-Medtronic instruments with its NavLock Tracker. Per Medtronics communication, the Indications for Use and "Warning" statement found in the labeling of the NavLock Tracker will be updated to state: Revised Indications for Use: "The NavLock Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic StealthStation surgical navigation system. The NavLock Trackers should only be used with Medtronic instruments." Strengthened Warning: "The NavLock Tracker is designed and tested for use only with Medtronic instruments. The use of non-Medtronic instruments with NavLock Tracker may result in inaccuracy, leading to serious injury or death." To date, the FDA has reviewed and cleared surgical stereotaxic navigation instruments produced b Continue reading >>

Sec Response Letter

On behalf of Medtronic Holdings Limited (New Medtronic) and Medtronic, Inc. (Medtronic), we aresubmitting this letter in response to the oral comments provided by the staff (the Staff) of the Securities and Exchange Commission on September24, 2014 with respect to the above-referenced Amendment No. 2 to theRegistration Statement (Amendment No. 2). As requested by the Staff, Medtronic and Covidien plc(Covidien) are supplementally submitting comparisons of the rights of their shareholders, respectively, as compared to the rights shareholders are expected to have in New Medtronic. The Medtronic shareholder rights comparison is attached hereto as Annex A and the Covidien shareholder rights comparison is attached hereto as Annex B. New Medtronic has filed today Amendment No. 3 to the Registration Statement (Amendment No. 3) together with this letter viaEDGAR correspondence. We are also providing supplementally to the Staff five copies of a version of Amendment No. 3, which has been marked to show changes since the filing of Amendment No. 2 to the Registration Statement on September 18, 2014. *** We hope that the changes toAmendment No. 3 adequately address the Staffs comments. If the Staff has any questions concerning this letter or requires further information, please do not hesitate to contact the undersigned or Victor I. Lewkow at (212) 225-2000. COMPARISON OF THE RIGHTS OF HOLDERS OF MEDTRONIC COMMON SHARES AND Asindicated in Medtronics response letter dated August26, 2014, the differences between the rights of holders of Medtronic common shares and New Medtronic ordinary shares are generally (i)either required by Irish law or(ii)necessary in order to preserve the current rights of shareholders of Medtronic and the powers of the Medtronic board under Minnesota law and th Continue reading >>