Posts tagged defective medical devices

• Boston Scientific Issues New Warning on Defibrillators

  Joe Saunders | May 17, 2006 7:25 AM | 0 CommentsSarasota, FL Category: Medical Malpractice
  

  Boston Scientific warned doctors that close to 1,000 of its cardiac implantable defibrillators may short circuit and fail to work properly leaving its patients vulnerable to cardiac problems. The company said that it learned of the failures after purchasing Guidant in April for $27.5 billion. U.S. regulators imposed sanctions on Guidant in December because of quality-control flaws after the...

• Boston Scientific to Pay Settlement for its Guidant Defibrillator

  Joe Saunders | July 14, 2007 11:28 AM | 0 CommentsSarasota, FL Category: Medical Malpractice
  

  The Boston Scientific Corporation has agreed to pay $195 million to approximately 4,000 people injured by the Guidant Ventak Prizm 2 Model 1861. The class action settlement was announced after the close of business yesterday and came on the heels of a federal trial that was to begin in 2 weeks. Judge Donovan W. Frank allowed the claims to go forward to trial and even stated that Boston...

• Boston Scientific's Mea Culpa

  Joe Saunders | February 05, 2006 10:05 AM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  Now that Boston Scientific, the maker of medical devices, has been publicly chastised by the FDA, its executives have taken a penitential tone. "It's clear we have not done enough to resolve the issues raised by the F.D.A., "a spokesman, Paul Donovan, said in a statement yesterday, "and we recognize fully that the responsibility to do so lies with us."Already, the F.D.A. has told Boston...

• FDA Warns of Burns from Dental Equipment

  Diego Madrigal | December 17, 2007 6:28 PM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  The FDA has issued a warning stemming from improperly maintained electrical dental equipment. The poorly maintained equipment can result in third degree burns. In fact, some of the patients even needed to undergo plastic surgery as a result. One of the main reason for the alert directed at dental professionals was that the burns may become apparent only after tissue damage has occurred...

• Sprint Fidelis Pacemaker Had Problems Last Winter

  Joe Saunders | October 25, 2007 8:13 AM | 0 CommentsSarasota, FL Category: Medical Malpractice
  

  Medtronic, the manufacturer of the Sprint Fidelis cardiac defibrillator a.k.a. pacemaker, knew that its medical device had problems with fractured lead wires last winter, according to consumer advocacy group Public Citizen. These defects were reported to the government last winter. According to Dr. Sidney Wolfe, the FDA had received 599 reports of defibrillator malfunctions as of January 10,...

• Sprint Fidelis Defibrillator May Pose More Risk to Young

  Joe Saunders | October 19, 2007 10:44 AM | 0 CommentsSarasota, FL Category: Medical Malpractice
  

  According to a Wall St. Journal article, the Medtronic Sprint Fidelis defibrillator may pose more risk to the young than previously thought. The Sprint Fidelis has had problems with its lead wire breaking causing erratic jolts of electricity to the heart. The wire connects the defibrillator to the heart and is supposed to jolt the heart rhythm back into a normal rhythm. However, the device...

• FDA Approves New Medtronic Stent in Spite of Report

  Joe Saunders | October 11, 2007 5:31 AM | 0 CommentsSarasota, FL Category: Medical Malpractice
  

  In spite of a recent scientific report citing certain health risks, the FDA voted to approve Medtronic's new cardiac stent, Endeavor. Data published a few days before the vote raised questions about the risk of blood clots linked to use of the drug coated stent. However, the FDA panel did suggest the FDA require that Medtronic conduct a 5 year post-approval study to assess the risks...

• US Supreme Court will Decide Pharmaceutical Co.'s Lawsuit Protection

  Patricia Doherty | October 02, 2007 2:51 PM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  The US Supreme Court announced it will decide a case regarding whether federal regulation of pharmaceutical companies preempts state law. The case the Court will decide arises from a products liaiblity lawsuit against Pfizer's Warner-Lamber unit involving its Rezulin diabetes drug. The FDA ordered Rezzulin off the market in March 2000 because it was linked to hundreds of deaths and cases of...

• Defibrillator Recall

  Sandy Grinnell | September 18, 2007 4:15 PM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  The FDA is recalling the MRL/Welch Allyn AED 20 Automatic External Defibrillator that is used by emergency personnel in hospitals, at fire stations and other risk management departments to treat heart attack victims. The defective equipment may show an error message (Defib Comm) which can result in the medical personnel giving improper treatment. Hospitals, fire departments, and ambulance...

• Controversial Stent Study Open to Question

  Staff Writer | March 27, 2007 8:08 AM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  A recent study concerning the utilization of cardiac stents has found that the stents are no more effective than medcines in preventing future heart attacks. However, the study was funded in part by pharmaceutical companies. This brings up a broader ethical issue concerning the objectivity of medical research, especially when that research is funded by organzations or companies that have a...