Medtronic Complaint Department

Fda, Doj File Complaint Against Medtronic Over Faulty Pain Drug Pumps

FDA, DOJ File Complaint Against Medtronic Over Faulty Pain Drug Pumps A recent Wall Street Journal report found that 14 deaths were tied to Medtronic's SynchroMed drug-infusion pumps. The Department of Justice (DOJ), in conjunction with the Food and Drug Administration (FDA), filed a consent decree and a legal complaint alleging that medical device maker, Medtronic, has distributed faulty SynchroMed drug-infusion pumps. The complaint alleges the pumps were not manufactured with current Federal good manufacturing practices and notes that the devices have been linked to serious injuries and deaths in recent years. Federal authorities reached a proposed consent agreement with Medtronic over the SynchroMed drug-infusion pump defects. The pump is used in treating cancer, severe chronic spasticity and to distribute pain medicine. When patients do not respond well to oral medication or suffer from severe side effects they may be treated with a medication pump. The DOJ and FDA complaint claims Medtronic distributed contaminated devices and that the pain pumps were not manufactured in accordance with good manufacturing practices. More specifically, Medtronic repeatedly failed to correct violations of FDA quality regulations. Through two different inspections the government uncovered significant violations of quality regulations. Under the proposed agreement, Medtronic will stop manufacturing and distributing new versions of the SynchroMed II implantable pump except in extraordinary cases. Medtronic will resume full distribution of the pump system only with permission from the FDA. The FDA warned Medtronic three times about quality control and manufacturing problems at its drug pump facility in Columbia Heights, Minnesota. The FDA issued a warning to Medtronic in 2012, which cit Continue reading >>

Medtronic, Inc. - Analysis

And Draft Complaint to Aid Public Comment The Federal Trade Commission ("Commission") has accepted for public comment from Medtronic, Inc. ("Medtronic" or "proposed Respondent") an Agreement Containing Consent Order ("the proposed consent order"). The proposed Respondent has also reviewed a draft complaint contemplated by the Commission. The proposed consent order is designed to remedy likely anticompetitive effects arising from the acquisition of Avecor Cardiovascular, Inc. ("Avecor"). Both Medtronic and Avecor are medical technology companies that compete in the manufacture and sale of non-occlusive arterial pumps, perfusion devices used in heart/lung machines. The proposed consent order remedies the acquisition's anticompetitive effects by requiring Medtronic to divest Avecor's non-occlusive arterial pump assets ("Avecor Pump Assets") as a viable, on-going product line. Medtronic has entered into an agreement to divest the Avecor Pump Assets to Baxter Healthcare Corporation ("Baxter"). Medtronic, which is headquartered in Minneapolis, Minnesota, is engaged in the research, development, manufacture and sale of medical devices, including implantable devices, such as pacemakers and defibrillators, which regulate heart rhythm; tissue and mechanical heart valves; coronary stents; and perfusion devices for heart/lung machines. Medtronic's perfusion devices include non-occlusive arterial pumps. Medtronic's Bio-Pump is the market leader in non-occlusive arterial pumps. Avecor, also headquartered in Minneapolis, Minnesota, is engaged in the research, development, manufacture and sale of perfusion devices, including, among other things, non-occlusive arterial pumps. Avecor introduced its non-occlusive arterial pump in the Fall of 1997. Avecor's pump, which utilizes different Continue reading >>

Fda Warns Medtronic Unit Over Handling Of User Complaints

FDA Warns Medtronic Unit Over Handling Of User Complaints Law360, Washington (August 21, 2012, 5:59 PM EDT) -- Medtronic Inc .'s neuromodulation unit was hit with a warning letter from the U.S. Food and Drug Administration that was made public Tuesday over issues stemming from the company's complaint handling processes and risk mitigation plans. The FDA's letter, dated July 17, listed several issues with Medtronic's ability to receive and process customer complaints, saying the company failed to transfer information from initial calls to its written records and that it needs to retrain and re-evaluate its efforts in order to create a complaint system. The agency pointed out several times where complaints received should have led to investigations into device malfunctions or been tagged for certain complaint qualities, but never were due to unknown reasons. Medtronic's neuromodulation unit creates implantable drug infusion, deep brain neurostimulation and spinal cord stimulation systems as well as nerve monitoring devices. Specifically, the agency had concerns that Medtronic's proposed actions to mitigate motor corrosion risks with its Synchromed II pump need to be revamped because they don't take into account all patients who may be affected by the issue. Your response describes actions taken to mitigate the risk of device failure through communication to health care professionals and decreased susceptibility of the device to corrosion, the letter said. However, we have concluded that your response is not adequate. The programmable infusion pump, used for chronic pain treatment, has had issues with motor gear teeth being partially or completely removed due to corrosion, which can cause the pump's motor to seize or stop working. According to the letter, Medtronic's anal Continue reading >>

April 2016: Medtronic's Lost Infuse Study, A Question Of Risk - Startribune.com

bony overgrowth, spinal-nerve inflammation, bowel and bladder problems, male sterility, breathing issues. But at the time Medtronic shut down its study, the FDAs public database of post-approval problems with medical devices contained just 261 reports about Infuse a quarter of the number of complications the company had gathered. Medtronic would eventually tell the FDA about more than 1,000 adverse events discovered through the study, more than five years after they were due. The FDA raised no issues about the late reporting and blacked out the total number of events from the three-sentence summary that became public. That number was revealed just months ago, after the Star Tribune challenged an FDA decision to keep it secret. Infuse Bone Graft is not a traditional medical device. Its key component is a vial of special powder that gets mixed with sterile water in the operating room. The bioactive solution contains a genetically engineered human protein known as BMP, or bone morphogenetic protein, that works like a drug inside the body to cause bone formation. In the 1990s, researchers realized that BMPs could transform common surgeries like spinal fusion. That procedure treats back pain caused by degenerative disc disease, but many patients require a second surgery to harvest living bone from the hip to graft vertebrae together. Lab-grown BMP offered the promise of bone graft without the time and pain of a second surgery. The commercial potential was clear to Medtronic executives, who were looking to diversify the companys product line beyond its traditional heart devices. In 1999, they paid $3 billion to buy a Memphis company that had exclusive rights to make a specific bone-growth protein, called rhBMP-2. Three years later, data gathered from clinical trials persuade Continue reading >>

Pxm Rpa Complaint Analyst - Technician

Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Lets work together to address the universal healthcare needs and improve patients lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together. At our Galway Product Return Analysis (RPA) Lab, which is part of the Product Experience Management (PXM) Complaint Handling and Regulatory Reporting Department in Medtronic, plc, we focus on Analysis and Investigation of devices returned from the field for which there is a complaint allegation. Complaint Device Analysis and Investigation is performed within a high performing PXM Complaint Handling and Medical Device Regulatory reporting department which provides value throughout the Product Life cycle through world class execution in MDR and Vigilance compliance and by ensuring patient safety through thorough and timely processing of complaint devices. You will be responsible the root cause investigation of complaint events based on details reported from the field and analysis of any returned product or supportive information, per departmental standards and procedures. You will also be responsible for entering all results related to investigation into the complaint handling database. You will generate regular Key Performance Indicators (KPI) report to monitor investigation activities. You will provide support to the Post Market Quality reliability departments through investigation activities. You will contribute to continuous improvement activities to support the role out of cell operati Continue reading >>

Medtronic In Court Over Alleged Insulin Pump Failure

The company is being sued for a man’s death, and has been sparring with the FDA over the quality of its pumps. In recent years, Medtronic has occasionally run afoul of federal regulators over issues with its pumps. Now the pump company must defend itself against a lawsuit for an insulin pump failure. According to a Courthouse News article, a 57-year-old New Jersey man who was using the MiniMed insulin pump system was found unconscious in his bed after his device failed. He remained in a coma for two weeks before passing away. The article says that Joann Hassan, who is serving as executrix of the man’s estate, has now filed a complaint and is seeking from Medtronic “punitive damages for breach of warranty, negligence, wrongful death, and other claims.” The suit claims the company has been negligent in training its quality control workers. The article did not provide Medtronic’s response to the suit. Medtronic has had trouble with its pumps as far back as 2009, when the FDA demanded that the company send out what would become the first of many recall notices, according to the Courthouse News article. In 2013, the FDA wrote a warning letter about Medtronic, saying that the manufacturing plant where the pumps were being made was still not up to code. Displeased with Medtronic’s adjustments, the FDA issued a Class 1 recall notice in July, stating that the device’s vents could become clogged, resulting in improper insulin delivery. The company’s pump troubles have not been limited to just insulin pumps. Recently, the LA Times reported that the FDA has filed a court order against Medtronic, severely limiting the making and distributing of the company’s implanted Synchromed II drug pumps, which are often used to treat cancer, chronic pain, and severe muscle sp Continue reading >>

Ethicspoint - Medtronic, Inc.

Prior to submitting this form, you will be asked to provide a password. Once you have submitted the form, the system will generate a unique report key, which you will need with the password to follow-up on your report, provide any additional information and upload any relevant documents. Note: You may provide additional information or upload attachments at any time after submitting this report. Medtronic established this site to provide an electronic method to raise concerns or allegations of non-compliance confidentially and, if desired, anonymously. This site and the toll-free hotline are operated by an independent company, EthicsPoint. All reports submitted using this website go directly to EthicsPoint and then routed to the appropriate persons within Medtronic, who will ensure that each report is handled in a professional and confidential manner. When you submit a report, you have the choice to remain anonymous or identity yourself. Either way, the more detail you provide in your report, the more effectively Medtronic can address your concern. This is not a 911 or Emergency Service: Do not use this site to report events presenting an immediate threat to life or property. Reports submitted through this service may not receive an immediate response. If you require emergency assistance, please contact Medtronic Security or your local authorities. Medtronic Patients: If you have questions or concerns about your Medtronic device, please contact Medtronic Patient Services by phone, fax, or US mail. If you think you may have a medical emergency, call your doctor or 911 if in the United States. As employees, we are obligated to report situations which may be potentially illegal; violate our Code of Conduct or stated company policies such as local Business Conduct Standards Continue reading >>

Government Spanks Medtronic Over Pain Pump

Source: RRY Publications LLC and Wikimedia Commons Government Spanks Medtronic Over Pain Pump The FDA has stopped fooling around and on April 27, 2015 asked the U.S. Justice Department to file a complaint and proposed consent decree with a federal judge regarding Medtronic plc's SynchroMed drug infusion system and the Neuromodulation quality system. The complaint alleges that Medtronic, its Chief Executive Officer Omar Ishrak and Senior Vice President Thomas Tefft, have been distributing medical devices in interstate commerce that are adulterated because they were not manufactured in accordance with current good manufacturing processes. "Defendants are well aware that their practices violate the [Food, Drug and Cosmetic] Act, " states the government filing. "FDA has repeatedly warned defendants, both orally and in writing, about their violative conduct." The company and government have agreed to resolve the allegations through the consent decree and Medtronic will be legally required to hire an outside expert to help correct the problems before manufacturing and selling any more of the devices. The decree outlines steps the company must take to address the FDA's expectations. The company says its efforts are focused on "the implementation of design changes to address issues the company has previously communicated, and on enhancing the Neuromodulation quality system. The agreement also includes a defined process by which Medtronic can continue to provide physicians with access to the infusion system for patients." The FDA issued the company three warning letters about quality control and manufacturing problems at its drug pump facility in Columbia Heights, Minnesota, between 2006 and 2013. The government said FDA inspectors visited the plant five times over that period. Continue reading >>

Medtronic Corporation And Executives Agree To Consent Decree To Resolve Allegations Of Food, Drug And Cosmetic Act Violations

Medtronic Corporation and Executives Agree to Consent Decree to Resolve Allegations of Food, Drug and Cosmetic Act Violations Medical device manufacturer Medtronic Corporation and two of its top executives have agreed to resolve allegations that they violated various provisions of the federal Food, Drug and Cosmetic Act (FDCA) with regard to the companys SynchroMed infusion pump. At the request of the U.S. Food and Drug Administration (FDA), the Justice Department today filed a complaint and a proposed consent decree in the U.S. District Court for the District of Minnesota. The complaint alleges that Medtronic, its chief executive officer, S. Omar Ishrak, and its senior vice president, Thomas M. Tefft, have been distributing medical devices in interstate commerce that are adulterated because they were not manufactured in accordance with current good manufacturing processes. The proposed consent decree will require Medtronic and its leadership to commit to making changes in their process that will benefit the American public by ensuring that their products are safe and effective for patients, said Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Departments Civil Division. The Department of Justice will not permit medical device manufacturers to shirk their responsibility to ensure that the devices that patients rely upon are safe. The defendants design, manufacture and distribute the SynchroMed II implantable infusion pump system, which is used to deliver medication to treat cancer, chronic pain and severe spasticity. Medical devices such as the Medtronics SynchroMed system are required to comply with FDAs quality system (QS) regulations. The complaint alleges that Medtronic repeatedly failed to correct violations of the QS regulations with Continue reading >>

Contact Us

We ask for full contact information only to consult your Medtronic records when replying to your question. We never share your contact information. Please note: We will respond to your comments or inquiry via email or telephone. Our email response will include your first and last names and will repeat your message to us, which could include personal information about your health. If this is a cause for concern, please call Medtronic Patient Services instead of submitting this form. For more information on how we safeguard your data, please review our privacy policy . Please note: We will respond to your comments or inquiry via email or telephone. Our email response will include your first and last names and will repeat your message to us, which could include personal information about your health. If this is a cause for concern, please call Medtronic Patient Services instead of submitting this form. For more information on how we safeguard your data, please review our privacy policy . Continue reading >>

Ex-sales Rep Sues Medtronic, Claims She Was Fired For Blowing The Whistle

Home Ex-sales rep sues Medtronic, claims she was fired for blowing the whistle Ex-sales rep sues Medtronic, claims she was fired for blowing the whistle A former sales rep for Medtronic s(NYSE: MDT ) neuromodulation business sued the company yesterday, alleging that she was fired for reporting violations both of Medtronics policies and of state and federal anti-fraud laws. Susan White was hired for her 2nd stint at Fridley, Minn.-based Medtronic in December 2011, according to the lawsuit, and did well enough in her initial training to win an award from the company. But during her training, White claimed in the suit, she observed Medtronic employees programming neurostimulation devices, touching and bandaging patients and promoting off-label uses for the devices all activities that violate Medtronics won rules, the False Claims Act and the Texas Medicaid Fraud Prevention Act, the lawsuit claimed. During and after repeated attempts to report the violations up through the chain of command, White alleged, her supervisors retaliated with verbal harassment and physical intimidation, setting her up to fail before ultimately engineering her firing on a pretext in April 2012. Medtronic retaliated against Susan White because she reported illegal activities and company policy violations. She courageously reported to multiple company officials, from her direct supervisor to Human Resources, and ultimately to Medtronics Legal Department. Medtronic officials responded harshly, labeling White not a team player and ultimately terminating her," according to the lawsuit. "In the brief period between her 1st complaints and the termination, Medtronics view of Whites performance went from complimentary [a]ll is good and way ahead of schedule to critical. What changed Continue reading >>

Feds Compel Medtronic To Sharply Limit Production Of Drug Pump

Medtronic is now based in Dublin, Ireland, but maintains its operational headquarters in Minneapolis. (This article has been updated with a correction.) Medtronic must drastically limit production and sales of its implantable infusion drug pump under a consent decree with federal regulators who say the company failed to ensure the product was safe. The U.S. Justice Department filed a consent decree reached with Dublin-based Medtronic and its CEO Omar Ishrak and Senior Vice President Thomas Tefft. The government filed the agreement and a civil complaint Monday in U.S. District Court in Minnesota. Medtronic was based in Minneapolis before acquiring Dublin-based Covidien this year, and the company maintains its operational headquarters there. The complaint alleges Ishrak and Tefft repeatedly failed to adequately address violations related to the production of Medtronic's Synchromed II Implantable Infusion Pump system after the Food and Drug Administration issued three warnings about the device between 2006 and 2013. The FDA said Medtronic lacked adequate processes to track and correct quality problems with the devices and failed to document design changes and ensure products met design specifications. The proposed consent decree will require Medtronic and its leadership to commit to making changes in their process that will benefit the American public by ensuring that their products are safe and effective for patients, Benjamin Mizer, principal deputy assistant attorney general of the Justice Department's Civil Division, said in a news release. As part of the agreement, Medtronic must stop producing and distributing the device except in cases where a physician certifies that the pump is medically necessary. Medtronic will also be required retain an outside expert to help Continue reading >>

Medtronic Whistleblowers Case In Jeopardy

Medtronic Whistleblowers Case in Jeopardy A former Medtronic employee who filed two whistleblower lawsuits has lost one case on appeal and is trying to convince a judge not to dismiss the second one. Jacqueline Poteet, who was the companys travel services manager, may lose the second case because she was not the first whistleblower to file suit. In this lawsuit, she is joined by Bobbie Vaden, another former Medtronic employee in Memphis who worked for 16 years in the companys accounting department. But two other former Medtronic employees, a corporate lawyer and a regional sales manager, filed earlier whistleblower complaints. Their allegations about physician kickbacks resulted in a $40 million settlement with the federal government in 2006. The complaint filed by two Memphis women is about a different scheme, according to a February 2007 filing in Boston federal court by their lawyer, Andrew Carr , an attorney at Bateman Gibson LLC . It relates to off-label uses of the Medtronic Infuse bone graft, alleged illegal payments to Medicare and Medicaid and more payments to physicians. Several doctors are also defendants in this lawsuit. Lawyers for Medtronic contend the womens assertions are about issues that have been publicly disclosed. They point to a decision by the Court of Appeals for the Sixth Circuit for reasons to dismiss the case. The Appeals Court this year affirmed the decision of Bernice Donald to dismiss Poteets first complaint from 2003 under the first-to-file provision of the whistleblower statute. That statute, the False Claims Act, provides financial incentives for people to report illegal activity, but it also has provisions to prevent opportunistic suits after the activity has been publicly disclosed. The Appeals Court judges in their opinion noted that Continue reading >>

Audit Committee Complaint Procedures

Pursuant to the Sarbanes-Oxley Act of 2002 and the Audit Committee Charter, the Audit Committee has established the following procedures for: (i) the receipt, retention, and treatment of complaints received by the Company regarding accounting, internal accounting controls, or auditing matters; and (ii) the confidential anonymous submission by Medtronic employees of concerns regarding questionable accounting or auditing matters. Medtronic publishes on its website special mail and e-mail addresses and a toll-free telephone number for receiving complaints, including complaints for accounting, internal accounting controls, or auditing matters. Copies of all complaints regarding accounting, internal accounting controls or auditing matters received will be sent directly to the Chief Compliance Officer. Copies of all complaints regarding accounting, internal accounting controls, or auditing matters will be provided on a quarterly basis to members of the Audit Committee; provided, however, that any such complaints received in respect of any executive officer of Medtronic will be brought to the Audit Committees attention within two business days. All complaints will be tracked on a separate Audit Committee complaints docket, but will be processed by the Companys Compliance Office, except as the Audit Committee may request. The status of the specially docketed complaints will be reported on a quarterly basis to the Audit Committee and, if the Audit Committee so directs, to the full Board. The Audit Committee may request special treatment, including the retention of outside counsel or other advisors, for any complaint addressed to it. Contact the Audit Committee and/or Board of Directors Please choose one of the below-listed options to report complaints about Medtronic's accounti Continue reading >>

Attorney General Rosenblum Announces $12 Million Settlement With Medtronic; Oregon To Receive $2.4 Million

Attorney General Rosenblum Announces $12 Million Settlement with Medtronic; Oregon to Receive $2.4 Million Attorney General Ellen Rosenblum today announced a five-state $12 million settlement with Medtronic Sofamor Danek, Inc. and Medtronic Sofamor Danek USA, Inc.(Medtronic) to resolve allegations that the company unlawfully promoted their Infuse Bone Graft Device used in spinal fusion procedures to doctors. Oregon will receive $2.4 million of the settlement. The settlement resolves the five states allegations against Medtronic for violating Oregons unfair trade practices laws. Oregon alleged that Medtronic made deceptive claims about Infuse by using trusted scientific publications to report that Infuse was superior to other therapies, and that patients who used Infuse experienced fewer side effects than what research actually showed. It is unacceptable for a company to use company-sponsored literature with misleading data to try to show that its product is more effective than other therapies, said Attorney General Rosenblum. By using these misleading claims, the company created a higher demand for Infuse in a range of surgerieswhich led to greater and undeserved profits for the company. The alleged misconduct was the subject of the June 2011 issue of The Spine Journal, which challenged the Medtronic-sponsored medical literature and studies. It was also the subject of a 16-month investigation by the Senate Finance Committee. In addition, Oregon Health Science University (OHSU) published an analysis by their evidence based medicine group, which found a higher rate of adverse events and lower effectiveness than reported in Medtronics company-sponsored studies. The research from OHSU was instrumental in Oregons case. The Complaint and Stipulated Judgment were submitted to Continue reading >>