Medtronic's Sprint Fidelis Defibrillator Lead Performance Update

05/14/2008 - It's now been six months since Medtronic's recall of their 7-French Model 6949 Sprint Fidelis defibrillator lead in October 2007. More>>>

Painful shocks linked to device

03/28/2008 - The defibrillator wire implanted in Belinda Jean Klein's chest was supposed to detect and correct arrhythmias in her heart. But in a federal lawsuit, the Evansville woman claims the device delivered painful shocks that led to her hospitalization instead. More>>>

Safeguards urged after recall of heart defibrillator lead

03/10/2008 - Airline passengers, cell-phone users and cable-TV customers enjoy more consumer protections than patients who have life-sustaining medical devices, a prominent cardiologist wrote recently in the New England Journal of Medicine. More>>>

Study: Extra ICD scrutiny not beneficial

03/06/2008 - Stepped-up monitoring intended to detect failures in recalled heart defibrillator leads made by Medtronic Inc. did little to warn patients of potential trouble with their devices, according to a study by the Minneapolis Heart Institute Foundation. More>>>

Medical device safety in spotlight

03/06/2008 - Doctors say that a massive product recall in October by Fridley-based Medtronic Inc. underscores the urgent need for legislation to protect recipients of medical devices by giving them and their physicians better information about emerging safety problems. More>>>

Recent Medical Device Recall Indicates Need for Patient Protections, NEJM Commentary Says

03/06/2008 - The October 2007 recall of the Sprint Fidelis defibrillator lead, manufactured by Medtronic, indicates the need for legislation that would improve information provided to patients and physicians about potential safety concerns in medical devices More>>>

Lead Shocks Send Patient to Psychiatrist, Courtroom

02/04/2008 - A patient affected by Medtronic’s 2007 recall of defibrillator leads is suing the company, claiming unnecessary shocks led to post-traumatic stress syndrome that required psychiatric treatment. More>>>

Cardiac implants caused loss of enjoyment of life

01/31/2008 - To treat life-threatening heart conditions, Texas residents Lawrence Booth and Larry Easter were given implantable cardiac defibrillators (ICD), to detect and correct both fast and slow heart rates. But the men believe the ICD's have caused them pain and suffering and have filed a lawsuit against the manufacturer. More>>>

Man seeks psychiatrist after Medtronic recall
01/23/2008 -  A Texas resident is claiming the unexpected shocks he received from a cardiac defibrillator constitute civil battery and caused him such severe anxiety that he is suffering from post traumatic stress and now requires psychiatric care. More>>>

Fremont man sues medical firm: Class-action lawsuit could affect thousands of Californians
01/03/2008 - A Fremont man has filed a class-action lawsuit against Medtronic Inc., a Minnesota-based medical technology company whose defibrillator wires for heart patients were recalled in October. More>>>

Heart-device failures keep patients on guard
01/02/2008 - Tom Kern had a potentially lifesaving heart device implanted in his body last year. Now he wonders if it might harm him instead. More>>>

Medtronic Resolves Defibrillator Lawsuits for $114 Million

12/27/2007 - Medtronic has agreed to settle lawsuits relating to its Marquis line of implanted cardiac defibrillators for $95.6 million plus $18.5 million in attorneys’ fees.

More>>>

Recalled Heart Implant Gives Man Shock Of His Life

12/27/2007 -  In early December, Jerry Jackson received the shock of his life. Or six. More>>>

Patients with Defective Medtronic Defibrillator Leads Face Difficult Decision
12/26/2007 - Just over two months ago Medtronic warned doctors and about 250,000 patients that a lead that is used to connect a defibrillator to the heart could potentially fracture. More>>>

Medtronic to settle ICD lawsuits for $114 mln
12/23/2007 -  Medtronic Inc said on Friday that it has agreed to settle 2,682 legal cases related to its Marquis line of implanted cardiac defibrillators for $95.6 million plus $18.5 million in attorneys' fees. More>>>

Medtronic to Pay $114 Million In Settling Heart-Device Suits

12/21/2007 -  Medtronic Inc. said it reached a $114.1 million settlement agreement to settle lawsuits related to its Marquis line of implanted cardiac defibrillators. More>>>

Medtronic Must Pay J&J for Patent Infringement
12/19/2007 - Medtronic lost a patent infringement case in federal court last week and must now pay $226.3 million to rival Johnson & Johnson (J&J).

A Medtronic subsidiary was found to have infringed on a spinal screw patent owned by DePuy Spine, a unit of J&J. More>>>

Senate Committee, Attorney's Office Examining Medtronic Payments

12/13/2007 - Leading device company Medtronic is dealing with a number of investigations related to its financial ties with physicians and hospitals, an SEC filing reveals. More>>>

Patients Wonder Whether to Replace a Wire That Might Fail

12/13/2007 - For one heart patient, there will be no more agonizing over whether the implanted device meant to save his life might kill him instead. More>>>

Preemption Gets Boost from Bush

12/12/2007 - A lawyer for the Bush administration declared last week that manufacturers of drugs and devices approved by FDA could not be held accountable for liabilities in state courts. The lawyer spoke in support of preemption in Riegel v. Medtronic, a Supreme Court case that could change the legal landscape of the pharma industry. More>>>

Supreme Court Hears Arguments in Device Preemption Case
12/11/2007 - The Supreme Court heard oral arguments in Riegel v. Medtronic last week and will rule on whether the express preemption provision of the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with FDA premarket approval (PMA). More>>>

Kentucky Resident Files Lawsuit Against Medtronic For Faulty Defibrillator Lead Wire

12/07/2007 - Kim Orange of Bowling Green, Kentucky, today filed a personal injury lawsuit against Medtronic Inc., for suffering devastating electrical shocks due to a defective lead wire system for her defibrillator. More>>>

Medtronic Payments Under the Microscope

12/06/2007 - In a Securities and Exchange Commission (SEC) filing, Medtronic announced the Senate Finance Committee is requesting information about the company’s financial ties with physicians. The committee also reqeusted information about its decision  to suspend distribution of its Sprint Fidelis family of defibrillation leads. Medtronic said it is cooperating with the requests. More>>>

Medtronic reveals records request

12/05/2007 - Medtronic Inc. said in a quarterly filing Tuesday that it received a letter in late October from the U.S. attorney's office for the Eastern District of Pennsylvania requesting documents relating to the Fridley company's relationship with an unnamed customer. More>>>

Medtronic Probed on Alleged Doctor Payments

12/05/2007 - Medtronic Inc. said it is under federal investigation for alleged payments made to doctors. More>>>

Medtronic, Medical-Device Makers Seek to Block Suits

12/04/2007 - Medtronic Inc. and other medical- device makers have a chance to win a new shield from patient lawsuits in a case before the U.S. Supreme Court.

In arguments today in Washington, the justices will consider whether patients can press product-liability lawsuits over devices cleared for sale by the Food and Drug Administration's most rigorous approval process. More>>>

Woman Sues Over Recalled Heart Device

11/27/2007- A Bismarck woman is worried about potential problems with her implanted defibrillator and is suing the company that made it. More>>>

More Faults in Halted Medtronic Device?

11/26/2007- Despite tactful handling of its Fidelis lead recall, Medtronic (MDT) may have more problems on the horizon with the insulated defibrillation wires, according to a Deutsche Bank research report late last week. More>>>

Medtronic Profit Tops Estimates, Despite Recall

11/20/2007- Medtronic said yesterday that second-quarter earnings fell 2 percent from a year ago as the recall of a component used with its implantable devices to treat abnormal heart rhythms hurt revenue. More>>>

Did Medtronic act quickly enough on recall?

11/20/2007- Medical device maker Medtronic said Monday its second quarter profits dipped 2 percent after it recalled defibrillator leads. Leads are wires that connect an implantable defibrillator to a patient's heart. The Fridley-based company recalled its Sprint Fidelis leads last month. Some think the company waited too long to take action. More>>>

Recall bites Medtronic earnings

11/20/2007- A massive product recall in October cut revenue and increased expenses during the second quarter for Fridley-based Medtronic, but the financial damage wasn't quite as bad as many feared. More>>>

St. Jude Shares Fall on Safety Concerns

11/12/2007- Shares of medical device maker St. Jude Medical Inc. fell Monday on concerns about the potential for lead wires on its Riata implantable defibrillators to puncture the hearts of cardiac patients. More>>>

A patient, an advocate, a fixer

11/10/2007- When it comes to her health, Laurel Lewis is positively fearless. The 54-year-old Minneapolis woman has stared down a rare breed of late-stage cancer. And last year, she technically died after her heart stopped beating, but luckily her near-fatal attack occurred just outside Fairview Southdale Hospital in Edina. More>>>

Investor sues Medtronic over ICD leads

11/08/2007- A shareholder alleges in a lawsuit filed Thursday that Medtronic Inc. and its top executives suppressed information about defects in a critical wire lead used with certain heart defibrillators. More>>>

Medical Device Preemption Decision May Hinge on FDA Position

11/06/2007- A Supreme Court decision on federal preemption authority for medical devices may hinge on the FDA’s position, and the agency has come out in favor of preemption. More>>>

Conference To Address Performance, Safety Of Defibrillator Lead Wires

11/05/2007- The safety and reliability of the wires (leads) that connect implantable cardioverter defibrillators (ICDs) to patients' hearts will be discussed and examined at the ICD Lead Performance Conference, to be held Thursday, Dec. 13. More>>>

Medtronic Spent $760,000 Lobbying

11/05/2007- Medical device maker Medtronic Inc. spent $760,000 lobbying the federal government in the first half of 2007, according to a disclosure form. More>>>

Wall Street Journal chronicles events leading up to Medtronic defibrillator lead recall

10/30/2007- Every medical device recall has a backstory, and today's Wall Street Journal (WSJ) provides, at least in part, the one that led to Medtronic removing one of its most successful products from the market earlier this month. More>>>

Warning issued on implanted defibrillators

10/24/2007- Some 100 cardiac patients with implanted defibrillators are being warned that the electronic devices could potentially harm their hearts. More>>>

FDA Device Approvals Under the Microscope

10/24/2007- In a letter to FDA Commissioner Andrew von Eschenbach, the House Committee on Oversight and Government Reform is requesting information on the agency’s regulation of medical devices. More>>>

Patients Sue Medtronic Over Defective Lead Wires

10/24/2007- Two former users of Medtronic’s Sprint Fidelis Defibrillation Leads are suing the company over injuries from the device. More>>>

Health officials contact Winnipeggers over defibrillator troubles

10/23/2007- The Winnipeg Regional Health Authority is contacting about 100 people in the Winnipeg area who have defibrillators with potentially defective wires attached to them. More>>>

F.D.A. Tests on Devices Scrutinized

10/23/2007- A Congressional committee notified the Food and Drug Administration yesterday that, as a result of a recall by Medtronic of a product linked to patient deaths, it was reviewing how rigorously the agency required heart device components to be tested. More>>>

Medtronic cease sales of Spirit Fidelis

10/23/2007- Medical technology firm Medtronic last week suspended all sales of a component used in its implantable devices to treat abnormal heart rhythms – due to fears the defective equipment may have contributed to the death of a number of patients. More>>>

At the heart of an implant component recall

10/22/2007- Last week, the Food and Drug Administration and heart device maker Medtronic told doctors to stop using a particular component -- the wire lead -- of Medtronic's latest generation of implanted heart defibrillators. Cardiologist Dr. William Maisel, a consultant to the FDA, explains what these devices do and what went wrong.

More>>>

Tough week for biomedical industry

10/19/2007- It has been a wild week in Minnesota's medical technology industry. Monday Medtronic stopped selling a device potentially linked to at least five deaths. More>>>

Suit against Medtronic seeks $550M damages

10/19/2007- Two Toronto law firms have launched a class-action lawsuit against U.S. medical device maker Medtronic and its Canadian subsidiary over implantable defibrillators linked to five deaths. More>>>

Hot Stocks of the Week: Medtronic

10/19/2007- Faulty wiring, quarterly earnings and the subprime mortgage crisis played major roles in shaping some of the most widely traded stocks for the week. More>>>

Heart Wires May Pose
More Risk for the Young

10/19/2007- The defibrillator leads pulled off the market this week by Medtronic Inc. may pose a higher risk of fracture in younger adults and children, a population for whom the devices were particularly popular in part because of their small diameter. More>>>

Tests of Heart Devices to Get Review

10/18/2007- The Food and Drug Administration is likely to study whether to require more extensive tests of critical heart-device components before they are sold, as a result of Medtronic’s recent problems with such a product, an agency official said yesterday. More>>>

Patients Sue Medtronic Over Defective Lead Wires

10/18/2007- Two former users of the Sprint Fidelis Cardiac Leads made by Medtronic filed suit for injuries sustained through the implantation of this device, law firm Rheingold, Valet, Rheingold said. More>>>

Medtronic Heart Device Injuries Up Dramatically In Past Year

10/16/2007- Consumer group Public Citizen has said that the tiny wires used with Medtronic Inc.'s implantable heart devices have jumped dramatically in the past year. More>>>

In Data for Heart Devices, Parts Are a Blind Spot

10/16/2007- Medtronic’s decision to stop selling a widely used part for implanted heart devices underscores the dearth of safety monitoring of such products, as well as a design trend that may make them increasingly prone to failure, several experts said yesterday. More>>>

Heart Device Recall Poses a Quandary for Patients

10/16/2007- On Sunday, when Medtronic warned physicians to stop using a potentially faulty wire attached to its heart defibrillators, the company also advised patients to consult their doctors. More>>>

Patients Warned as Maker Halts Sale of Heart Implant Part

10/15/2007- The nation’s largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component in its most recent defibrillator models because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths. More>>>

Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads

10/15/2007- Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.

More>>>

Medtronic suspends sale of heart devices

10/15/2007- Medical devices maker Medtronic Inc. said on Monday it suspended sales of a component to heart devices known as defibrillators, saying the equipment may have contributed to five patient deaths. More>>>

Medtronic Halts Distribution of Defibrillation Leads

10/15/2007-Medtronic Inc., the world's largest maker of electronic heart devices, withdrew wires that connect implantable defibrillators to the heart and projected lower revenue. The stock fell the most in a year. More>>>

UPDATE: Medtronic Received SEC Letter On Informal Probe

10/12/2007- Medtronic Inc. (MDT) is among several medical-device companies that have received letters from the U.S. Securities and Exchange Commission regarding an informal probe into possible violations of the Foreign Corrupt Practices Act, a Medtronic spokeswoman confirmed Friday. More>>>

Medtronic's Bid to Dismiss Lawsuits Denied
11/29/2006 - Minneapolis-based Medtronic, manufacturers of a controversial implantable cardioverter defibrillator (ICD), had their motion for summary judgment denied in U.S. District Court, meaning that the company may still have to face personal-injury lawsuits regarding their allegedly faulty product. More >>>>

Whistle-Blower Suit Says Device Maker Generously Rewards Doctors
01/24/2006 - A prominent surgeon in Wisconsin was paid $400,000 a year by Medtronic for a consulting contract requiring him to work just eight days. Another doctor in Virginia received nearly $700,000 in consulting fees from Medtronic for the first nine months of 2005. More >>>>

Medtronic reports pacemaker defect
11/30/05 - Medtronic Inc., the world's biggest maker of electronic heart devices, said Tuesday it is notifying doctors about a potential defect in some of its Sigma series pacemakers. More >>>

Medtronic Says Some Pacemakers May Have Faulty Wires
09/29/2005 - Medtronic Inc. <MDT.N> said on Tuesday it is advising physicians of a potential problem in a small number of its Sigma pacemakers in which wires may separate from a circuit. More >>>

Medtronic Announces Voluntary Recall of Certain Monophasic LIFEPAK 500 Automated External Defibrillators
FDA
02/25/2005 - FOR IMMEDIATE RELEASE -- Redmond, WA, February 25, 2005 -- Medtronic, Inc. (NYSE: MDT) today announced that it is voluntarily recalling a limited number of LIFEPAK 500 automated external defibrillators (AEDs). The AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed. This action affects 1,924 first-generation LIFEPAK 500 AEDs that were manufactured in 1997, which represents approximately 1 percent of LIFEPAK 500 AEDs currently in use worldwide. This action does not affect any other LIFEPAK 500 AEDs currently produced, or any other LIFEPAK product. More >>>

Medtronic Issues Notification Regarding Certain Implantable defibrillator Models
FDA
02/11/2005 - FOR IMMEDIATE RELEASE -- Minneapolis, MN, February 11, 2005 -- Medtronic, Inc., (NYSE: MDT) today said it is voluntarily advising physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. In a letter to physicians, Medtronic reported that nine batteries (0.01 percent or approximately 1 in 10,000) have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths. More >>>

Medtronic Recalls Two Implantable Heart Devices
04/16/04 - Medtronic Inc. on Friday said it was recalling two older models of certain heart devices after the company became aware of four deaths and one serious injury that could be related to the failure of a key part of one of them. More >>>

Ennis & Ennis, P.A. is representing individuals that have been harmed defective medical devices such as the Medtronic defibrillator and pacemaker. If you or a loved one have suffered as a result of a defective Medtronic pacemaker or defibrillator or if you need more information about the Medtronic recall or class action lawsuit click here for a free, confidential case evaluation.