Medtronic Pacemaker News Archive

 

Medtronic Recalls Its Quick-set Infusion Sets
-Diabetes Health
07/22/2009 - Minneapolis-based Medtronic Inc. is recalling some lots of its Quick-set infusion sets over concerns that they may cause insulin pumps to deliver too much or too little insulin. More>>>

Medtronic Recalls 60,000 Paradigm Quick-Set Infusion Sets
-US Recall News
07/14/2009 - Medtronic has issued a recall of specific lots of infusion sets that are for use with MiniMed Paradigm insulin pumps. These infusion sets may not work properly, resulting in a delivery of too little or too much insulin, which could result in injury or death. More>>>

Medtronic Paradigm Quick-Set Infusion Sets
-FDA MedWatch
07/13/2009 - Medtronic, Inc. and FDA notified healthcare professionals and patients of a recall of Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps because the affected infusion sets may not allow the insulin pump to vent air pressure properly. More>>>

Medtronic Voluntarily Recalls Specific Lots of
Paradigm® Quick-Set® Infusion Sets In The United States
-FDA
07/13/2009 -  Medtronic, Inc. (NYSE:MDT) said today (07/10/2009) that it has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. More>>>

Medtronic Recalls Insulin Devices
-The Wall Street Journal
07/12/2009 - Medtronic Inc. is recalling three million insulin-infusion sets, estimating that 60,000 of them could cause improper insulin delivery and lead to serious injury or death. More>>>

FDA Alerts Patients to Medtronic Pacemaker Recall
-FDA News
06/11/2009 - The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.  More>>>

Patients injured by faulty medical devices want laws to hold manufacturers accountable
-Cleveland.com
05/13/2009 - Two summers ago, Bill Storms of Delaware, Ohio, says he got 138 electrical jolts over a five-hour period when the wires to his pacemaker went haywire. The 38-year-old truck driver had to visit several emergency rooms before the device could be turned off. More>>>

Faulty Cable Affects Thousands Of Heart Patients
-KGTV
05/02/2009 - SAN DIEGO -- A heart device that has been pulled off the market can still be found inside the bodies of thousands of people, including at least one San Diegan. More>>>

Removing Medtronic Heart Cables Is Hard Choice
-TheNewYorkTimes
04/07/2009 - BOSTON — Pulling a medical device off the market is one thing. Removing it from the bodies of thousands of patients is a lot more complicated and dangerous. Consider the Sprint Fidelis, a heart defibrillator cable. In 2007 its maker, Medtronic, stopped selling it after five patients who had the cables died. More>>>

Patients head to D.C. to lobby for right to sue Medtronic
-Minnesota Independent
04/01/2009 - Diana Levine sees a double-standard in the law. As her own case proves, people can sue when they are harmed by pharmaceuticals, but individuals hurt by defective medical devices cannot. She appears in a new video that targets Twin Cities-based defibrillator manufacturer Medtronic to support passage of the Medical Device Safety Act, which would effectively overturn the 2008 Supreme Court ruling in Riegel v. Medtronic that prevents patients receiving faulty devices from suing. More>>>

Medtronic Says Broken Heart Wires Tied to 13 Deaths
-Bloomberg
03/14/2009 - Medtronic Inc. said fractures of wires in its cardiac defibrillators “may have been a possible or likely contributing factor” in 13 deaths, more than double the number initially suspected. More>>>

Patients' lawyers in Medtronic cases want new judge
-StarTribune
03/05/2009- Plaintiffs' lawyers in a set of lawsuits against Medtronic Inc. have asked for the recusal of U.S. District Judge Richard Kyle, who recently threw out hundreds of suits over a heart device manufactured by the Fridley-based firm. More>>>

Study Finds More Failure of Heart Device
-NewYorkTimes
02/24/2009- A widely used heart device recalled two years ago by Medtronic may be failing in patients at a rate significantly higher than previously known, a new report by two prominent cardiac specialists indicated. More>>>

Judge Who Dismissed Hundreds of Medtronic Injury Cases Biased? Plaintiffs May Get New Life in Court
-Attorneyatlaw
02/14/2009- In a shocking twist to a landmark legal case, a Minnesota federal judge who recently dismissed the cases of hundreds of people allegedly injured by Medtronic Inc. heart-device wires has a son who is an attorney at a law firm which has represented the medical device maker in the past. More>>>

Medtronic Pain Pumps Recalled
-InjuryBoard.com
09/30/2008- The FDA has issued a recall for Medtronic drug pumps. The recall notice came Friday. The pumps involved are the Indura 1P Intrathecal Catheter, model 8709SC; Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. More>>>

Medtronic catheter faces class 1 recall : Drug-pump part linked to one death
-TwinCities.com
09/27/2008- The U.S. Food and Drug Administration has determined problems with a Medtronic catheter used in many of the company's implantable drug pumps should be considered a class 1 recall — the most serious type. More>>>

Consumers v. Huge Corporations: The Medical Device Debate
-InjuryBoard.com
09/21/2008- Last February in Riegel v. Medtronic, the Supreme Court ruled that a severely injured person was barred or pre-empted from filing a lawsuit against Medtronic Corporation because the medcial device manufactured by Medtronic had been previously approved by a federal regulatory agency, namely the FDA, even though the medical device caused severe injuries to the patient. More>>>

11 more lawsuits for Medtronic on Sprint Fidelis leads
-Finance and Commerce
09/14/2008- Lawsuits involving the recalled implantable Sprint Fidelis leads are piling up for Fridley-based Medtronic. Just in the last five days, 11 separate lawsuits have been filed in district courts in Texas and Tennessee, pushing the total number of similar lawsuits against Medtronic beyond 300 since the company recalled the leads in October 2007. More>>>

Medtronic Whistleblower Case Could Change Back Surgeries
-InjuryBoard.com
09/08/2008- A federal whistleblowers case and a couple of legislative investigations are looking at the connection between Medtronic and the surgeons that uses their products for back surgeries. The question at the heart of each action is : Are surgeons being paid to use and recommend these products? Initial payment information suggests that this could be happening. More>>>

Defibrillator Shocks Signal Increased Death Risk, Study Finds
-Bloomberg
09/04/2008- Heart failure patients who get a lifesaving shock from implanted cardiac defibrillators are five times as likely to die in the coming months and years, typically from progression of the disease, researchers said. More>>>

Medtronic’s Sprint to the marketplace
-InjuryBoard.com
08/29/2008- Medtronic’s rapid move into the market place with the Sprint Fidelis defibrillator lead contrasts with the dead slow recall of a medical device that defies a physical recall. More>>>

Woman testifies on Capitol Hill over Medtronic device
-ksax.com
06/12/2008- A Medtronic defibrillator fails, shocking a Pennsylvania woman more than two dozen times. But even though she wanted to sue the Fridley company, she couldn’t. More>>>

Medical Device Ruling Redraws Lines on Lawsuits
-NYTIMES.com

02/22/2008 -The Supreme Court’s decision Wednesday protecting many types of medical device makers from personal injury lawsuits began rippling through the courts and law offices almost immediately. More>>>

Lead Shocks Send Patient to Psychiatrist, Courtroom
-FDA News

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
-Southeast Texas Record
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
- Southeast Texas Record
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
-Trading Markets

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
-Orlando Sentinel

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>>>

Recalled Heart Implant Gives Man Shock Of His Life

-Tyler Morning Telegraph
12/27/2007 -  In early December, Jerry Jackson received the shock of his life. Or six. The 63-year-old Mineola resident was sweeping crumbs off the bed where his granddaughter sat when a sudden surge in his chest caused him to twist in agony. More>>>

Patients with Defective Medtronic Defibrillator Leads Face
Difficult Decision
-Boston Now

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. The leads, called Sprint Fidelis, were recalled by Medtronic on October 15, 2007 after reports of fractures, unnecessary shocks, and death. While Medtronic has said that most patients do not need to have their leads replaced, but this has not assuaged the thousands of patients who have these leads implanted. More>>>


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

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>>>

Patients Wonder Whether to Replace a Wire That Might Fail
-New York Times

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.On Tuesday, two months after Medtronic warned doctors and nearly a quarter-million patients that a wire, or lead, connecting their electronic defibrillators to their hearts might break, the 48-year-old patient had the lead and defibrillator removed and replaced. More>>>

Preemption Gets Boost from Bush

-PharmExec.com
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
-FDA News
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>>>

Medtronic reveals records request
- The Star Tribune, MN

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
- The Wall Street Journal
12/05/2007 - Medtronic Inc. said it is under federal investigation for alleged payments made to doctors. The Minneapolis medical-device maker said in a Securities and Exchange Commission filing that the Senate Finance Committee has requested information about ties between the medical-device industry and practicing physicians and information about Medtronic's suspended distribution of its Sprint Fidelis family of defibrillation leads, electrical wires that connect patients' hearts to defibrillators implanted in their chests. More>>>

Medtronic, Medical-Device Makers Seek to Block Suits
- Bloomberg
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. A federal appeals court barred a suit that claims a New York man suffered permanent injury when a Medtronic heart catheter burst during an angioplasty. More>>>