Category Archives: Medtronic Defibrillators
Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting
An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...
Bronx Teenager Killed in Hit-and-Run, Second Teen Injured
A Port Jefferson Station man was killed on Wednesday in a single-vehicle crash on the Northern State Pkwy in Dix Hills west of Exit 42. He was driving a Nissan Altima.
Birth Control Shot Depo-Provera may Increase HIV Risk, Study Suggests
A new study has linked the use of Depo-Provera (medroxyprogesterone acetate), an injectable type of birth control, to an increased risk of HIV infection.
EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects
Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...
New Study Links Metal-on-Metal Hip Replacement Corrosion with Adverse Local Tissue Reactions
Yet another study is pointing to potential dangers posed by metal-on-metal hip implants. This time, an article published in the Journal of Arthroplasty is reporting corrosion in the head taper junction was more likely to occur in patients with 36-mm diameter metal-on-metal hip replacement, compared to those with the same ...
Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings
Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.
Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch
Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.
Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda
A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...
FDA Safety Warning for Bone Graft Products in Patients Under 18
FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.Medtronic Agrees to $9.9 Million Settlement in Physician Kickback Case
The Justice Department announced yesterday that Medtronic Inc. has agreed to pay the United States $9.9 million to resolve allegations that the company made illegal payments to physicians to induce them to implant Medtronic pacemakers and defibrillators. Assistant Attorney General … Continue reading
Boston Scientific Subpoenaed Over Implanted Cardiac Defibrillators
Boston Scientific Corp. received a subpoena this week from the Department of Health and Human Services (HHS), seeking information about the performance of some of its implanted cardiac defibrillators. The May 5 subpoena came from HHS’s Office of the Inspector … Continue reading
Medtronic Denied Preemption in Another Device Injury Lawsuit
An Indiana appeals court just ruled that Medtronic cannot use so-called “preemption” to get out of a negligence lawsuit filed over a failed Transvene defibrillator lead. Preemption is legal concept that a number of medical device makers have used in … Continue reading
Younger People Opting for Joint Implants, Despite Long-Term Potential for Problems
Medical devices long only considered for use in the elderly are being embraced by younger generations; however, some are concerned about device safety and oversight and the long-term potential for problems with these products. In fact, many key players in … Continue reading
FDA Calls for Cybersecurity Safeguards for Medical Devices
The U.S. Food and Drug Administration (FDA) issued a safety alert on Thursday recommending that medical device manufacturers and health care facilities take steps to secure implantable medical devices and hospital equipment against cyberattacks, which could threaten patient lives and … Continue reading
Infuse® Maker, Medtronic, Cutting Staff
Device maker, Medtronic Inc., just announced another scheduled staff cut. We recently wrote that Medtronic was laying off about 4 percent of its spinal business workforce worldwide, which amounted to about 230 of it spinal division’s 5,600 employees, This is … Continue reading
Lawsuit filed against Medtronic for those injured by Entrust pacemaker, Sprint Fidelis leads
Three people who’ve been seriously injured as a result of defective cardiac defibrillators and their component parts manufactured by medical device maker Medtronic Inc. have sued the company for hiding data on the risks they posed to patients, and their … Continue reading
Riata Heart Lead Study Confirms Failure Risk
A new study that confirms the high rate of an erosion problem that led to the recall of St. Jude’s Riata heart defibrillator leads has found that such failures are most likely to occur with wires that have large diameters. … Continue reading
Canadians Sue Over Faulty Medtronic Defibrillator Leads
Canadians are suing Medtronic over faulty Sprint Fidelis defribllator leads. The faulty leads were globally recalled by Medtronic in 2007. Lead wires are placed into a major vein and attached to interior heart muscle for the purpose of monitoring heart … Continue reading
Medtronic Settles Charges Over Kickbacks To Doctors
Medical device giant, Medtronic Inc., is settling charges over kickbacks to doctors. The firms just agreed to pay $23.5 million to settle claims it paid physicians kickbacks in exchange for their use of its pacemakers and defibrillators, according to a … Continue reading
