Category Archives: Medtronic Defibrillators
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 ...
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, ...
Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery
DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...
Three Injured When Long Island Railroad Train Hits Car on Tracks
3 people, injured on Wednesday at 1:20 p.m. when a LIRR train hit a livery cab on the tracks west of Wyandanch station. The train engineer, who suffered a shoulder injury.
Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System
Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...
Smith & Nephew Recalls Metal-on-Metal Hip Implant Component
Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.
Dozens-Receive-Nonsterile-Simulated-Saline-Solution
The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.
Tentative Ohio Fracking Regulations Criticized as too Lax
Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.
Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries
More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.
New York Man Claims Biomet Metal-on-Metal Hip Implant Caused Pain, Disability
A New York man claims his metal-on-metal hip implant was defective and required replacement within a year of receiving it. This has left him facing a lifetime of pain, disability, and rising medical costs.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
