Medtronic Insulin Pump Recall Initiated In Light of Cybersecurity Risks
Medtronic has recently issued a recall of certain products in the MiniMed insulin pump product line. The Medtronic insulin pump recall began after the U.S. Food and Drug Administration (FDA) found credible proof that the products in question could be vulnerable to a cybersecurity breach. A Summary of The Medtronic Insulin Pump … [Read more...]
Medtronic Pacemaker Alert Issued Following Power Failure In Models
Medtronic pacemaker alert notices can be chilling news to patients who use them. Since pacemakers are surgically implanted, the solution to these revelations may take days, weeks, or months to implement and in that time any number of complications. On May 7, 2019, the U.S. Food and Drug Administration (FDA) released a Medtronic … [Read more...]
FDA Class I Recall of Medtronic HeartWare HVAD Systems Due to Injury or Death
The medical device industry has seen a significant number of recalls recently, many of which are “Class I,” the most serious type of recall a medical device company can face. According to the Food and Drug Administration (FDA), pharmaceutical drugs and medical devices that are subject to a Class I recall may cause serious injury or … [Read more...]
Medtronic Mini-Med Insulin Infusion Sets Worldwide Recall
Mini-Med Insulin Infusion Sets Worldwide Recall. In a September 11, 2017 press release, Medtronic announced a worldwide recall of some Mini-Med infusion sets used with Medtronic insulin pumps. The recall is related to a discontinued component in the infusion sets and does not include either the insulin pumps or glucose sensors … [Read more...]
Medtronic Allegedly Knew of Defects in their Devices
Defects In Medtronic Devices. Medtronic devices have been available to the public since 1998 and 1999 and have been under significant scrutiny in recent times. The latest issue arose in the earlier part of 2017, with a Class 1 recall involving software connected to the SynchroMed Implantable Infusion Pump. A Class 1 recall is the … [Read more...]
Medtronic Quick-Set Infusion Set Overdose Lawsuits
Medtronic PLC Issues Insulin Infusion Set Recall Amid Hypoglycemia Fears. Medtronic PLC, a medical device company, is based in Ireland and one of the largest medical device manufacturers in the world, issue a recall for infusion sets used with its insulin pumps in September 2017. Medtronic issued a voluntary recall for particular … [Read more...]
Sprint Fidelis Lead Fracture Rates Questioned
Risk Of A Sprint Fidelis Fracture “increased significantly". How often does Medtronic Inc.'s recalled Sprint Fidelis defibrillator lead fracture? According to some major hospitals, more often than what Medtronic has stated. According to The Wall Street Journal, Medtronic says its own research shows the Sprint Fidelis leads … [Read more...]
Medtronic Pacemakers Side Effects May Lead To Personal Injury Lawsuits
Medtronic Pacemakers Side Effects. Medtronic Inc. announced they are advising physicians of a potential problem in a small number of its Sigma pacemakers in which wires may separate from a circuit. No deaths or injuries were reported, though some users suffered dizziness or fainting, according to the Fridley-based medical-devices … [Read more...]
Medtronic Pacemaker Sigma Kappa Side Effects
Medtronic Pacemaker Sigma Kappa Side Effects. If you have a Medtronic Kappa or Sigma pacemaker, and have experienced symptoms associated with abnormal heart rate, such as fainting or lightheadedness, your device may be defective. In June 2009, Medtronic Inc. issued an urgent recall of certain Kappa and Sigma pacemakers because of … [Read more...]
Medtronic Infuse® Associated with Cauda Equina Syndrome
Cauda Equina Syndrome Medtronic Infuse. Have you been diagnosed with Cauda Equina Syndrome (CES)? Prior to your diagnosis, did you undergo a Medtronic INFUSE® spinal fusion surgery? Medtronic INFUSE® is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2 or BMP2) approved for use in a particular type of spinal … [Read more...]
Medtronic Infuse Cancer Side Effects Lawsuit
Medtronic Infuse Cancer Side Effects. Research has indicated that there may be a strong association with Medtronic Inc.'s Infuse Bone Graft product, and cancer, specifically: Prostate Cancer Breast Cancer Pancreatic Cancer Recently, reports have also raised questions about Medtronic's handling of clinical … [Read more...]
Medtronic Infuse Side Effects Lawsuits
Medtronic Infuse Side Effects. Off-label use of Medtronic Inc.’s Infuse bone graft product in cervical spine surgeries, as well as lateral approach or posterior approach spinal procedures, has been linked to serious, and even life threatening side-effects. Some of these Medtronic Infuse injuries include ectopic or uncontrolled … [Read more...]
Medtronic Infuse Bone-Growth Lawsuit, Side Effects Cancer Risk
Medtronic Infuse Bone-Growth. Medtronic Inc's Infuse bone graft, a bioengineered bone-growth product used in spinal surgery, has been linked to a greater cancer risk than previously thought in patients treated with high doses of Medtronic's controversial protein. People who received Infuse, especially in off-label procedures, may … [Read more...]
Medtronic Infuse Bone Graft Becomes Controversial Due to its Side Effects
Medtronic Infuse Bone Graft Side Effects. Medtronic Infuse is a medical device that is supposed to help re-grow bone in the spine, but it has become controversial because of safety concerns. Infuse has been linked to side effects such as cancer, male sterility and, excess bone. Most recently, in November 2013, a report posted on … [Read more...]
Medtronic Deep Brain Stimulation Wire Fractures Risk
Medtronic Deep Brain Stimulation (DBS) Devices Injury Lawsuits. Parker Waichman is investigating potential lawsuits on behalf of individuals who suffered injuries related to Medtronic's Deep Brain Stimulation (DBS) devices, which are used to treat motor coordination problems in patients diagnosed with Parkinson's disease, tremor, and … [Read more...]
Medtronic Concerto Side Effects Injury Lawsuits
Medtronic Concerto Side Effects. The FDA on January 30, 2007 announced that the agency started an investigation that is looking into accusations by a former Medtronic Inc. engineer that the medical-device company didn't sufficiently test its new Concerto cardiac device for patients with congestive heart failure. The local office … [Read more...]
U.S. Senate Finance Committee Faults Medtronic on Infuse® Studies
Medtronic Infuse Studies Investigation. A just-released U.S. Senate Finance Committee report accuses medical device maker, Medtronic Inc., of editing self-funded journal articles and paying physicians massive sums for Medtronic-sponsored studies of its Infuse® bone-grafting product. The Committee issued its 2,315-page report … [Read more...]
Marketing Authorization for Medtronic InductOs Device Suspension
European Medicines Agency Recommend Suspension of Marketing Authorization for Medtronic's InductOs. The European Medicines Agency (EMA) has recommended the suspension of marketing authorization for Medtronic's InductOs, an implant to help bone development, until issues are resolved at a U.S. plant where a component of the implant is … [Read more...]
FDA Places Most Serious Recall Label on Medtronic Heartware HVAD Issue
Heartware Ventricular Assist Device Cause Problems In Patients. Medtronic Heartware HVAD Recalls Issue. Heartware, a subsidiary of Medtronic, has recalled its Heartware Ventricular Assist Device (HVAD) due to problems with its driveline connector tubes. The Medtronic Heartware HVAD issue can cause the pump to stop working. The … [Read more...]
Deep Brain Stimulation Devices Charging Problems
Errors In Deep Brain Stimulation Devices Result To Failures. Medtronic Deep Brain Stimulation Devices Chargers Malfunctioning. Medtronic has warned that some of its Model 37751 rechargers for its deep brain stimulation devices may be malfunctioning. In an "Urgent Field Safety Notice" addressed to healthcare professionals this … [Read more...]
FDA Recalls Medtronic Heart Pump Calling it Life-Threatening
Defective Medtronic Heart Pump Is Taking Lives? Medtronic Life-Threatening Heart Devices. The Medtronic heart pump is an HVAD System which takes over for a failing heart. Basically, the system helps to support individuals with heart diseases while they wait for a heart transplant. Flaws, however, surfaced with the heart device … [Read more...]
Two Medtronic Infuse Plaintiffs Obtain $8.45M in Settlements
Two Medtronic Infuse Plaintiffs Will Receive $8.45M. Two individuals who filed lawsuits over Medtronic's controversial Infuse bone graft product will receive a combined total of $8.45 million in settlements. Each of their lawsuits alleged that they were not informed about the risky procedures involving Infuse, which were allegedly … [Read more...]
Medtronic Warns of Wire Fractures with Deep Brain Stimulation (DBS) Device
Notice for Deep Brain Stimulation Wire Fractures. Medtronic issued an Urgent Field Safety Notice involving its Deep Brain Stimulation (DBS) devices, which are used to treat movement disorders including Parkinson's Disease, Tremor and Dystonia. In a letter to physicians, the company said it identified 16 reports of high impedance … [Read more...]
Senator Franken Presses Medtronic and FDA for Clarity in Infuse Study
Clarity in Infuse Study Under Investigation By AuthoritiesSenator Al Franken to Inquire Further About Details Involving the Medtronic Bone Graft. An article published by the Star Tribune has caused United States Senator Al Franken to inquire further about details involving the Medtronic bone graft device known as Infuse. In a … [Read more...]
Medtronic Halted Infuse Study and Hid Data Report Says
Medtronic Has had A Number Of Issues Regarding Infuse Medtronic has had a number of issues regarding Infuse, a bone graft product that has become controversial amidst allegations that it hid complications in industry-funded studies, among other things. Now, The Minneapolis Star Tribune has published a report indicating that the … [Read more...]
Premature Notification System in Cardiac Monitor Leads Medtronic Australasia to Issue Hazard Alert
Hazard Alert for Premature Notification System Of Insertable Cardiac Monitor Device. An Insertable Cardiac Monitor (ICB) is a small device that is implanted in the upper chest to continuously monitor heart rhythms and alert the wearer of any irregularities in the heart beat. The hazard alert is due to a defect in the device that … [Read more...]
Medtronic Uses Preemption in Medtronic Infuse Case, Again
US supreme court denied the case of medtronic. US supreme court denied the case of medtronic.The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While a shallow … [Read more...]
For Second Time within a Year, Puritan Bennett 980 Ventilators Are Recalled
Puritan Bennett 980 Ventilators Are Being Recalled. For the second time within a year, Medtronic PLC has recalled Puritan Bennett 980 ventilators; this time because a software glitch may cause the machine to deliver too little oxygen in the neonatal setting. Medtronic began notifying hospitals in July of the latest problem, the … [Read more...]
Recently Approved Medtronic Heart Valve Device under Class 1 Recall
Recall of the EnVeo R loading system has been designated a Class 1 recall. A component Medtronic's CoreValve Evolut R heart valve device is under Class 1 recall less than two months after receiving Food and Drug Administration (FDA) approval. The recall of the EnVeo R loading system has been designated a Class 1 recall, which is … [Read more...]
Medtronic Recalls Heart Device Loading System Due to Particulates
Medtronic Recall Its Heart Device. Reports are gathered about the presence of particulates in the EnVeo R Loading System. Medtronic has announced the voluntary recall of its EnVeo R Loading System, which is used with its CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR). The manufacturer received eight … [Read more...]
Medtronic’s Shiley and Pediatric Tracheostomy Tubes Recalled
Medtronic Inc. to initiate the recall of 8,192 Shiley Neonatal Pediatric and Tracheostomy Tubes. Medtronic’s Shiley Neonatal and Pediatric Tracheostomy Tubes Recalled Because of Patient Breathing Difficulties. Reports of breathing difficulties in patients switched from older models of tracheostomy tubes to newer models prompted … [Read more...]
Contamination Problems Prompt EMA to Review Medtronic’s InductOs
InductOs is used to help stimulate bone growth in patients undergoing spinal fusion in the lower back. Contamination issues have prompted the European Medicines Agency (EMA) to conduct a review of Medtronic's InductOs, an implantable bone-development product. Regulatory Affairs Professionals Society reports that Spanish and Dutch … [Read more...]
Medtronic Recalls MiniMed Insulin Pumps Due to Inaccurate Bolus Screen Issue
Agency labeled the recall as Class 2, meaning there is a reasonable risk of serious adverse events or a remote risk of serious events. An inaccurate bolus screen issue has prompted a recall of nearly 2,000 MiniMed 640G insulin pumps in ten European countries. According to a recall notice posted on the U.S. Food and Drug … [Read more...]
Medtronic’s Payments to Doctors Raises Questions
Data Show That Medtronic Still Makes Payments to Doctors. Federal data show that Medtronic still makes payments to doctors over InFuse, a controversial spine product that has prompted questions about industry-funded research. Star Tribune reports that 79 doctors and their affiliates received a total of $60.7 million from ‘Medtronic’ … [Read more...]
Medtronic Recalls 70,000 Tracheostomy Tubes Following Reports of Breathing Troubles
Some patients had trouble breathing while using the Covidien Shiley tube. Some 70,000 tracheostomy tubes for infants and children are being recalled by Medtronic PLC following injury reports. According to Star Tribune, reports indicate that some patients had trouble breathing while using the Covidien Shiley tube. The disposable tubes … [Read more...]
Lawsuit Filed over Medtronic Infuse Bone Graft Product
Lawsuit Alleges that the Medtronic InFuse Bone Graft Caused Serious Injuries. A recently filed lawsuit alleges that the Medtronic InFuse Bone Graft and LT Cage product caused serious injuries, including excessive bone growth. The suit, which represents numerous individuals implanted with the device, was filed by Jerrold S. Parker of … [Read more...]
Urgent Alert: Insulin Pump Tubing May Detach
Insulin Pump Tubing May Detach. Health Canada, Canada’s health regulatory agency, and manufacturer, Unomedical, have issued a safety alert to insulin pump users. There is a risk that in certain sets the tubing carrying the insulin may detach from the pump. The potential safety issue involves certain models of infusion sets … [Read more...]
Three Medtronic Infuse Personal Injury Cases Remanded to Circuit Court
Three lawsuits filed against Medtronic, Inc. over injuries associated with its Infuse bone graft device will be remanded to the Circuit Court of the City of St. Louis for further proceedings, according to the law firms Parker Waichman LLP, Neblett Beard & Arsenault, and The Drakulich Firm, which are collaborating on the … [Read more...]
Infuse Lawsuit May Affect Medtronic Acquisition of Covidien
Class Action Lawsuit Dilemma Medtronic's $43 billion acquisition of Covidien, which is already controversial, may be influenced by a class action lawsuit over its Infuse bone growth product. According to Star Tribune, if a jury rules in favor of the plaintiff, many patients may be able to sue over injuries. Medtronic has used the … [Read more...]
Medtronic Duet External Drainage and Monitoring System Recalled
Line tubing may separate from the patient line connectors, and can result in serious adverse health consequences. Medtronic Neurosurgery has recalled the Duet External Drainage and Monitoring System (EDMS) because the line tubing may separate from the patient line connectors, and can result in serious adverse health consequences, … [Read more...]
Humana Files Lawsuit Against Medtronic Over InFuse
Company misrepresented its Infuse bone growth product as safe and effective in spinal fusion surgeries. Managed care company Humana Inc. has filed a lawsuit against medical device maker Medtronic, alleging the company misrepresented its Infuse bone growth product as safe and effective in spinal fusion surgeries. The suit was filed … [Read more...]
Lawsuits Over Infuse Bone-Growth Product Could Cost Medtronic Up to $140 Million
Hundreds of lawsuits over its InFuse bone-growth product. Medtronic Inc. will record a charge between $120 million and $140 million in its fourth quarter results for hundreds of lawsuits over its InFuse bone-growth product, the company said on Tuesday. The medical device maker, based in Fridley, Minnesota, has already agreed to … [Read more...]
Medtronic Infuse Lawsuit Moves Forward as Motion to Remand is Granted
Individuals who are suing Medtronic over the bone graft product InFuse are a step closer to trial. A number of individuals who are suing Medtronic over the bone graft product InFuse are a step closer to trial, as their motion to remand has been granted. The case will be brought from federal court back to the Circuit Court of the City … [Read more...]
Medtronic Faces Lawsuits from 1,000 Infuse Patients, More Expected
Several states are now investigating the sales and marketing practices involving Infuse. Medtronic is being sued by over 1,000 patients who received its Infuse bone graft product. Additionally, several states are now investigating the sales and marketing practices involving Infuse. The bone morphogenetic protein-2 (BMP-2) product is … [Read more...]
Medtronic Denied Motion to Dismiss InFuse Lawsuit
Lawsuit allegations include that InFuse led to complications that resulted in permanent disability. Medtronic Inc.’s recent bid to dismiss a lawsuit brought over its bone graft product, InFuse, was denied by an Illinois state court judge. Lawsuit allegations include that InFuse lawsuit led to complications that resulted in permanent … [Read more...]
Medtronic SynchroMed Infusion Pumps Class I recall
Class I recall on two models of Medtronic SynchroMed drug infusion pumps According to a recall statement from the agency, the recall involves SynchroMed drug infusion pumps manufactured since May 1998 until November 2012. They were distributed from April 1999 until November 2012. The Class I recall indicates that it is the agency's … [Read more...]
Senate investigation details Medtronic’s influence on clinical data
Medtronic Inc. paid hundreds of millions of dollars to influence clinical data. A Senate investigation has confirmed that medical device maker Medtronic Inc. paid hundreds of millions of dollars to influence clinical data on its INFUSE bone growth product. According to a Milwaukee Journal Sentinel report, the Senate Committee on … [Read more...]
Medtronic Announces Layoffs
Medtronic Controversy Surrounding Its Infuse Products. Medtronic announced in May it would be cutting some 1,000 jobs, as the controversy surrounding its Infuse Bone Graft product continues to weigh on the medical device maker’s bottom line. "We are eliminating about 1,000 positions around the company and around the globe," Gary … [Read more...]
Medtronic Reports Another Bad Quarter for Infuse Bone Graft
Medtronic Infuse is a synthetic form of recombinant human Bone Morphogenetic Protein. Medtronic Inc's spine business is still suffering as a result of all of the controversy surrounding its Infuse Bone Graft product. According to Medtronic’s earnings report for the first quarter of 2013, sales of Infuse are down 19% from a year … [Read more...]
Medtronic Discloses California Infuse Investigation
California Infuse Investigation Underway. Medtronic continues to be plagued by investigations into its controversial Infuse bone growth product. According to its most recent 10-Q filing with the Securities and Exchange Commission (SEC), the California Attorney General issued a subpoena to the company in October seeking … [Read more...]
Medtronic Infuse Associated with Higher Rate of Cancers than First Believed
Higher Rate of Cancers Noted In Lawsuits. Dr. Eugene Carragee, a Stanford University School of Medicine professor and editor of The Spine Journal. has raised more questions about Medtronic Inc.'s Infuse bone growth product. According to Carragee, Infuse may be more strongly associated with cancer than previously thought. In June, … [Read more...]
Expect Big Fallout from Medtronic Infuse Scandal, Analyst Says
Fallout Could Lead From Medtronic Infuse. The latest furor over Medtronic Inc.'s Infuse bone growth product will likely lead to increased regulatory scrutiny of the spine device, as well as possible class action lawsuits, a Wall Street analyst says. According to a Forbes report, Larry Biegelsen of Wells Fargo says the fallout could … [Read more...]
Medtronic Infuse Disclosures Put Medical Journals in Spotlight
Some medical journals are facing fire again over their conflicts-of-interest policies in the wake of the latest Medtronic Infuse scandal. The latest Medtronic Infuse controversy indicates that many prestigious medical journals aren't doing enough to spot obvious financial bias. Last week, The Spine Journal published an entire … [Read more...]
Journal Questions Integrity of Medtronic Infuse Studies
Medtronic influenced what it characterizes as misleading and biased Infuse studies. A major medical journal is slamming studies for Medtronic Inc.'s Infuse Bone Graft product, asserting that information regarding side effects was omitted from final published articles. The Spine Journal questions whether researchers’ financial … [Read more...]
Senators Questions about Medtronic Infuse Studies
Medtronic Infuse Studies. Medtronic is facing more scrutiny over its Infuse Bone Graft product. Senator Max Baucus (D-Montana), the chairman of the Senate Finance Committee, and Senator Chuck Grassley (R-Iowa), the committee's ranking Republican, want to know about payments the device maker made to doctors who published … [Read more...]
Medtronic Sprint Fidelis Defibrillator Lead Settlement Announced
Medtronic Sprint Fidelis Defibrillator. Medtronic Inc. has agreed to pay $268 million to settle thousands of lawsuits involving its defective Sprint Fidelis defibrillator leads. The Sprint Fidelis lead was recalled in October 2007 after it was determined to have a higher than normal fracture, or breakage rate. Sprint Fidelis lead … [Read more...]
Divided FDA Panel Backs Medtronic Spine Device
Medtronic Spine Device Cancer Risks. Although federal health regulators are concerned that a new Medtronic spine-stabilizing device may increase cancer risks for some patients, the Orthopedic and Rehabilitation Devices Panel of the U.S. Food and Drug Administration's (FDA's) Medical Devices Advisory Committee just voted to endorse … [Read more...]
New Medtronic Spine Device Cancer Risks
New Medtronic Spine Device. Federal health regulators are concerned that a new Medtronic spine device may increase cancer risks for some patients. According to a Wall Street Journal report, the device, called Amplify, is made with recombinant bone morphogenetic protein-2 (rhBMP-2). RhBMP-2 is used in another Medtronic spine device … [Read more...]
Medtronic Faces Lawsuit Over Biliary Stent Marketing
A whistleblower lawsuit has been filed against Medtronic Inc., claiming that the device maker illegally marketed biliary, or bile-duct, stents. A whistleblower lawsuit has been filed against Medtronic Inc., claiming that the device maker illegally marketed biliary, or bile-duct, stents. According to The Wall Street Journal, … [Read more...]
Senator Grassley Looking for Funding Conflicts at 33 Non-Profit Medical Groups
Infuse Bone Graft Study Conducted At Walter Reed Draws Scrutiny
Infuse Bone Graft Contains Recombinant human Bone Morphogenetic Protein. Another study of Medtronic Inc.'s Infuse Bone Graft product that involved soldiers at Walter Reed Army Medical Center is coming under fire. According to a report in the Minneapolis Star Tribune, Dr. Charles Rosen, president of the Association for Medical Ethics, … [Read more...]
Medtronic Cardiac Rhythm Gets FDA Warning Letter
Medtronic Cardiac Rhythm Receives Warning Letter. Device maker giant, Medtronic, Inc., just announced that it received a warning letter from the U.S. Food & Drug Administration (FDA). According to the Twin Cities Business Journal, the letter came after an inspection of Medtronic’s Mounds View Cardiac Rhythm Disease Management … [Read more...]
More Claims Filed over Medtronic Sprint Fidelis Leads
Medtronic Sprint Fidelis Leads Get More Lawsuits. Three more lawsuits against Medtronic, Medtronic USA, Medtronic International Technology, and Medtronic Puerto Rico Operations, reports the Madison Record. The three individuals, residents of Illinois, allege in their 60-count suit, that they suffer sudden shocks after being implanted … [Read more...]
Medtronic Issues Class I Recall for Sutureless Connector Intrathecal Catheters
Medtronic Inc. is recalling Sutureless Connector (SC) intrathecal catheters. In letters sent to physicians, Medtronic said that that the current SC catheter labeling incorrectly states that SC catheters are compatible with the IsoMed infusion pump. According to a Medtronic press release, the Food & Drug Administration (FDA) … [Read more...]
Medtronic-Paid Spine Surgeon Resigns From Medical Group Board
Dr. David Polly, a prominent spine surgeon whose financial relationship with Medtronic Inc. had recently come under scrutiny, has resigned from the board of the American Academy of Orthopaedic Surgeons. As we've reported previously, Polly had come under fire for not disclosing his relationship with Medtronic when he testified … [Read more...]
Surgeon in Medtronic Infuse Study Scandal Resigns
Timothy R. Kuklo, the former Army surgeon who has been accused of falsifying data in a study of Medtronic Inc.'s Infuse Bone Graft, has resigned from his post at Washington University Medical School, according to The New York Times. As we’ve reported previously, the study, which Kuklo conducted during his tenure at Walter Reed … [Read more...]
Witnesses Voice Support for Medical Device Safety Act
Medical Device Safety Act. Earlier this week, a Senate hearing was convened to discuss the Medical Device Safety Act of 2009. If it becomes law, the Medical Device Safety Act would restore important legal rights to victims of a defective medical device. Patients lost many of those rights in 2008, when the U.S. Supreme Court issued … [Read more...]
Infuse Bone Graft Researcher was Paid by Medtronic
Infuse Bone Graft Researcher Fails. A spine surgeon who had a financial relationship with Medtronic Inc. did not disclose that relationship when he testified before a Senate committee urging more funding for research into combat-related injuries, The Wall Street Journal is reporting. One of Medtronic's products, Infuse Bone Graft, … [Read more...]
Lawsuits Allege Medtronic, Other Firms Illegally Marketed Surgical Ablation Products
Surgical Ablation Products Sold Illegally. Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in … [Read more...]
Infuse Bone Graft Study Doc Fails to Reveal Info
Infuse Bone Graft Study Doc Fails To Reveal Info. The former Army surgeon at the center of a scandal involving falsified data in an Infuse Bone Graft study apparently did not tell his current employer that he had been a paid consultant to Medtonic Inc., The Wall Street Journal is reporting. Infuse Bone Graft, which is … [Read more...]
Infuse Bone Graft Study Info Sought by Senate Armed Services Committee
Infuse Bone Graft Study Probe Heats Up. A Senate investigation into a bogus Infuse Bone Graft study is heating up. According to The Wall Street Journal, the Senate Committee on Armed Services has asked the U.S. Army to provide it with the results of an investigation into the Infuse Bone Graft study, which was conducted at Walter … [Read more...]
BMP Protein Products Linked to Complications in Neck Spine Surgery
BMP Protein Products Linked to Complications. BMP protein, a bone growth agent used in products like Medtronic Inc.'s Infuse Bone Graft, may be responsible for serious complications when used to treat neck pain, and may not be cost effective, according to a new study. The study, conducted by researchers at Brigham and Women's … [Read more...]
Medtronic Says Subpoena Seeks Info on Infuse Bone Graft Study
Medtronic Told To Explain Infuse Bone Graft Study. Medtronic Inc. has been served with a federal subpoena over a falsified Infuse Bone Graft study conducted by a former army surgeon. According to The Wall Street Journal, the subpoena was revealed in a disclosure to the Securities and Exchange Commission (SEC) Medtronic made … [Read more...]
Author of Questionable Infuse Bone Graft Study Got Big Bucks from Medtronic
Windfall for Former Army Surgeon Medtronic Inc. has confirmed that it paid hundreds of thousands of dollars to an ex-Army surgeon who is accused of falsifying data in a study he conducted on the company's Infuse Bone Graft product. According to the Associated Press, Medtronic paid the surgeon - Dr. Timothy Kuklo - $850,000 over a 10 … [Read more...]
Medtronic Issues Class I Recall for Some Pacemakers
Some Medtronic Pacemakers Recalled For Wiring Issues. Medtronic Inc. is issuing a Class I recall for certain Medtronic Kappa and Sigma pacemakers because of wiring issues that may cause the devices to fail. A Class I recall is the Food & Drug Administration's (FDA) most serious recall action, and is issued when there is a … [Read more...]
Grassley Wants to Know Why Infuse Study Doctor Was Left Off List of Consultants Paid By Medtronic
Senator Wants Medtronic To Explain. Senator Charles Grassley (R-Iowa) is seeking an explanation from Medtronic Inc. for its failure to list Dr. Timothy Kuklo as a paid consultant when it submitted a list of such physicians to him in October. As we've reported previously, Kuklo is the former Walter Reed Army Hospital surgeon who … [Read more...]
Medtronic Says Kappa, Sigma Pacemakers May Have Wiring Problems That Could Lead to Device Failures
Medtronic Says Kappa, Sigma Pacemakers Have Problems. Medtronic Inc. is warning that wiring issues with its older-model Kappa and Sigma implantable defibrillators could pose a risk to patients. According to a letter sent to doctors, the pacemakers may fail at a higher-than-expected rate due to separation of wires that connect the … [Read more...]
Dodgy Infuse Bone Graft Study Catches Grassley’s Attention
Senator Keen on Dodgy Infuse Bone Graft Study. A scandal involving a falsified Infuse Bone Graft study conducted at Walter Reed Army Hospital has caught the attention of medical industry watchdog, Sen. Charles Grassley (R-Iowa). According to The Wall Street Journal, Grassley has sent letters about the study to Walter Reed, … [Read more...]
Retracted Infuse Bone Graft Study Used Falsified Data, Forged Signatures
Retracted Infuse Bone Graft Study. A scandal involving Medtronic Inc.'s Infuse Bone Graft has erupted in the U.S. Army. According to The Wall Street Journal, "a number of serious questions" have been raised about an Infuse study conducted by Dr. Timothy R. Kuklo, former surgeon at Walter Reed Army Medical Center in Washington, … [Read more...]
Medtronic Sprint Fidelis Leads: Doctors, Patients Face Tough Choices
Medtronic Sprint Fidelis Leads. The procedure to remove one of Medtronic Inc.'s defective Sprint Fidelis defibrillator leads is dangerous and complicated. According to a report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices. A … [Read more...]
Medtronic Recalls BioGlide Ventricular Shunt Catheters
BioGlide Ventricular Shunt Catheters Has Problems. A class I recall has been issued for Medtronic BioGlide Ventricular Shunt Catheters. A class I recall is issued when a device poses a risk of serious injury and death. The recalled Medtronic BioGlide Ventricular Shunt Catheter is part of a system used to treat a condition called … [Read more...]
Medtronic Letter Links Sprint Fidelis Leads to 13 Deaths, Possibly More
13 deaths blamed on sprint fidelis leads. Medtronic's Fidelis defibrillator leads have been implicated in at least 13 deaths and could be linked to scores of others. That's up from the five fatalities Medtronic reported when the Fidelis leads were first removed from the market in 2007. A lead is a wire that connects an … [Read more...]
Lawmakers Introduce Medical Device Lawsuit
FDA warns Medical Device Lawsuit against erring makers. Democrats in Congress just introduced measures to allow consumers harmed by a medical device approved by the U.S. Food and Drug Administration (FDA) to sue the device manufacturer in state court, reports Medical News Today. The move came the day following a Supreme Court ruling … [Read more...]
Medtronic Marketing Of Cardiac Ablation Therapy Sparks DOJ Probe
Medtronic faces federal probe over cardiac ablation therapy. Medtronic Inc. is facing a federal investigation over its marketing of cardiac ablation therapy. The revelation was made in a regulatory filing Wednesday. Cardiac ablation therapy involves threading devices through tubes in the circulatory system to burn, freeze or … [Read more...]
Device Makers Say They Favor Comparisons
Dow Jones reported that the industry supports the comparison only. Comparative Effectiveness, a component of the just-passed economic stimulus plan, is allegedly receiving favor by some top executives in the medical device industry. Not everyone agrees. Dow Jones reported that the industry supports the comparison only as long as … [Read more...]
Medtronic to Publicize Doctor Payments
Doctor Payments Creates Problems In America. Medtronic Inc. said yesterday that it will soon begin disclosing the consulting fees, royalties or honoraria in excess of $5,000 that it pays to doctors and researchers. According to the Minneapolis Star Tribune, Medtronic is the largest medical tech company to make such … [Read more...]
Medtronic Sprint Fidelis Risk Grows Over Time
Sprint Fidelis defibrillator leads still putting patients at risk. A new study has found that Medtronic's Sprint Fidelis defibrillator leads are still putting patients at risk. The Sprint Fidelis leads were removed from the market in October 2007 because of their higher-than-normal fracture rate. A lead is a wire that connects an … [Read more...]
Judge Who Dismissed Sprint Fidelis Lawsuits Linked to Medtronic Law
Judge Has a Personal Connection to The Sprint Fidelis Lawsuits. A judge who recently dismissed hundreds of Medtronic defibrillator injury lawsuits apparently has a personal connection to the device maker. According to The Wall Street Journal, the son of Judge Richard H. Kyle of the federal district court in Minneapolis is … [Read more...]
Medtronic Sprint Fidelis Victims Look to Congress for Help
Victims Ask for Help. Lawsuits filed by victims of the defective Medtronic Sprint Fidelis lead are in legal limbo. Thanks to a ruling last year by the U.S. Supreme Court, it is unclear if they will be able to sue Medtronic for painful injuries caused by the Sprint Fidelis defibrillator lead. According to an article in the … [Read more...]
University Responds to Conflict-of-Interest Scandal
Officials say they are taking steps to resolve the problem. Reacting to the widely publicized conflict-of-interest scandal, University of Wisconsin (UW) officials say they are taking steps to resolve the problem at their School of Medicine and Public Health, The Capital Times said. Dr. Thomas Zdeblick is the UW researcher who … [Read more...]
Infuse Bone Graft Doc Got $19 Million from Medtronic
Study Finds Medtronic Infuse Bone Graft Frequently Used Off Label
Off-label use of bone graft products like Infuse linked to serious complications. At least 17 percent of procedures using Medtronic's Infuse Bone Graft are off label, according to a new Cleveland Clinic study. This is disturbing, as off-label use of bone graft products like Infuse has been linked to serious complications. Infuse … [Read more...]
Dozens of Medtronic Sprint Fidelis Lawsuits Dismissed
Federal judge dismisses Sprint Fidelis Lawsuits. Even while acknowledging that Medtronic Inc.'s defective Sprint Fidelis defibrillator lead caused serious injuries to plaintiffs, a federal judge yesterday dismissed dozens of Sprint Fidelis lawsuits on the grounds of preemption. Preemption is a legal doctrine that federal regulation … [Read more...]
Medtronic Infuse Bone Graft to be Named in Another Lawsuit
Medtronic could be facing more trouble over Infuse Bone Graft. Medtronic could be facing more trouble over its Infuse Bone Graft product. According to a report on the website "Finance and Commerce", a Texas woman is preparing to file a lawsuit that blames off-label use of Infuse for injuries she suffered after cervical spine … [Read more...]
FDA to Be Informed of Infuse Bone Graft Death
Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein. Medtronic Inc. said it is going to inform the Food & Drug Administration (FDA) about the death of a patient treated with its Infuse Bone Graft product in an off-label procedure. The death occurred in August, but according to a report in The Wall Street … [Read more...]
Group Slams Medtronic for YouTube Ads
Device makers are illegally advertising on the popular video-sharing Website. A watchdog group, The Prescription Project, is alleging that device makers are illegally advertising on the popular video-sharing Website YouTube.com, says Pharmalot.com. According to the report, The Prescription Project has petitioned the U.S. Food and … [Read more...]
Infuse Bone Graft Problems Result in DOJ Subpoena for Medtronic
Complications related to off-label use of the Infuse Bone Graft. Off-label use of Medtronic Inc.'s Infuse Bone Graft product is the subject of a subpoena filed by the U.S. Department of Justice, the company recently revealed. Complications related to off-label use of the Infuse Bone Graft and similar products prompted the Food & … [Read more...]
Head Phones Interfere with Implanted Heart Devices
Implanted heart devices may have problems with head phones. A new study has revealed that some headphones can interfere with implanted heart devices such as pacemakers or defibrillators, when the headphones and the devices are in close proximity, such as when the headphones are in a shirt pocket or when they are draped around the … [Read more...]
U of Minnesota Medical School Considers Banning Most Gifts to Doctors
Minnesota Medical School Conflict-of-interest Policies. The University of Minnesota Medical School is considering adopting what would be one of the toughest conflict-of-interest policies in the country. If enacted, the proposed new policy would ban most - if not all - industry gifts to doctors at the school. The ties between drug … [Read more...]
Senators Probe Industry Ties to Medical Device Conference Organizers
Medical Device Conference Organizers. Two lawmakers have written to the organizers of the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C. about the financial support they receive from five medical device companies, including Johnson & Johnson, Medtronic Inc. and Abbott Laboratories. Senator Charles Grassley … [Read more...]
