Posts tagged Medical Devices

• Medtronic Defibrillator Leads Recalled

  Shannon Weidemann | October 22, 2007 9:29 PM | 0 CommentsColorado Springs, CO Category: Medical Malpractice
  

  Defibrillator leads that connect an implanted defibrillator have been recalled. The defective medical device is made by Medtronic and may cause the device to function incorrectly. The name of the product is Medtronic Sprint Fidelis Defibrillator Leads. The FDA has advised patients who are implanted with this recalled Medtronic defibrillator lead or do not know the model of their lead, to...

• Sleep Apnea Flow Generators Recalled

  Shannon Weidemann | April 30, 2007 10:45 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  Some flow generators used in the treatment of sleep apnea have been recalled. ResMed is voluntarily recalling S8 flow generators made between July 2004 and May 15, 2006 because the power supply connector may short circuit. This creates a potential for machine failure, sparks and fire. Patients may continue to use their S8 flow generators until they receive a replacement device. As with any...

• Suits over hernia mesh patch on the rise

  Staff Writer | December 27, 2006 9:33 AM | 0 CommentsColorado Springs, CO Category: Medical Malpractice
  

  Earlier this month a law firm out of Mt. Pleasant, South Carolina, announced that they are filing suit on behalf of their client against Davol, Inc., the manufacturer of Composix Kugel Mesh Patch, which as been used in a number of hernia repair surgeries. The defective medical device has been known to cause serious complications in patients who have undergone hernia surgery in which is was...

• Court Denies Medtronic's Motion for Summary Judgement

  Staff Writer | December 15, 2006 10:37 AM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  Defibrillator manufacturer Medtronic asked the US District Court of Minnesota to consider a motion for summary judgement. Their request was based on the claim that federal preemption barred the plaintiffs' claims. The plaintiffs' main complaint sites state law product liability claims sounding in negligence and strict liability. Other claims include violations of state Consumer Protection...

• Medtronic Fails to Warn Public of Malfunctioning Battery

  Staff Writer | December 15, 2006 10:30 AM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  According to Medtronic's website, "Medtronic is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world." Medtronic manufactures cardiac resynchronization therapy defibrillators (CRT-D's) and implantable cardioverter-defibrillators (ICD's). These devices are used on patients with heart conditions and are surgically...

• Defibrillators and Pacemakers

  Staff Writer | October 02, 2006 8:51 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  On September 29, 2006, The Heart Rhythm Society (HRS) finalized recommendations for revising the system used by industry, regulators and clinicians to monitor and publicize implantable-device performance problems. Key goals of the recommendations include:• improved recognition of potential device malfunctions• postmarket surveillance and reporting of any problems• communication among...

• FDA Warning to Medtronic on Defibrillators

  Staff Writer | September 29, 2006 7:17 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  The FDA issued a warning to Medtronic, Inc. on Friday, September 29, 2006 regarding the delayed filing of a post market surveillance interim report on the AneuRx Stent Graft System. According to Medtronic, Inc. the letter is not related to the quality, design or manufacture of the product. However, the purpose of the Postmarket study is to make sure the device is appropriately labeled for use...

• Boston Scientific's Taxus Stent

  Staff Writer | September 07, 2006 11:10 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  About 85,000 Taxus stents are being recalled voluntarily by Boston Scientific because of possible defects. Of the 42 complaints received, 30 systems showed actual performance flaws generally thought to be the result of excess heat being applied during the laser welding stage during the manufacture of the product; 200 Taxus stents were recalled earlier this month. In a meeting with the FDA in...

• Defibrillator Manufacturer Warned by the FDA

  Staff Writer | August 09, 2006 10:19 PM | 0 CommentsGrand Junction, CO Category: Medical Malpractice
  

  Medical device manufacturer Cardiac Science Corp. received a formal warning from the FDA demanding that they correct safety procedures used to manufacture defibrillators. The automated external defibrillators (AEDs) are used in public locations such as government offices, sports stadiums, shopping centers and schools. They are designed to treat heart attacks by restoring healthy heart rhythms....

• FDA Announces Recall of Certain Welch Allyn Automated External Defibrillators

  Staff Writer | July 31, 2006 6:39 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  The US Food and Drug Administration (FDA) and MRL, Inc (a Welch Allyn company), recently notified healthcare professionals about the class 1 recall of 1184 automated external defibrillators ([AEDs] Welch Allyn PIC 50, catalog #97108X) manufactured during February 2002 to October 2004; 673 units were sold within the United States.The recall occured because of an electrical contact problem that...