Posts tagged Defective Medical Devices

• How safe are you in the hospital?

  Jamie Sheller | February 20, 2008 3:13 PM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  Is it safer to be in the hospital during the day when having a heart attack than in the evening? According to recent research, a higher percentage of heart attack patients get better care during the day at a hospital, than between the hours of 11 pm and 6 am. Apparently, hospitals are better staffed and more attentive to patient needs during the day. Sadly, those who rely upon the staff the...

• Postarthroscopic Glenohumeral Chondrolysis caused by pain pumps

  Jamie Sheller | January 03, 2008 4:22 PM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  Postarthroscopic Glenohumeral Chondrolysis, or PAGCL, is a painful condition in the shoulder caused when the cartilage between the humeral head and the ball and socket of your shoulder has broken down to the point where bone meets bone. Recently, studies have shown that pain pumps used after shoulder surgery is a leading cause for this pain. While these products are still available on the...

• Thoratec Implantable Ventricular Assist Devices Recalled

  Jamie Sheller | November 20, 2007 2:40 PM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  Thoratec Corporation has recalled its Implantable Ventricular Assist Devices (IVAD) catalog number 10012-2555-001, serial numbers 488 or higher. The recalled devices were manufactured and distributed from October 1,2 004 through October 22, 2007. These IVAD's are used to help pump blood through the body of a person whose body is too weak to perform that function. The IVAD can be implanted or...

• Micro-bubble contrast agents may cause death or serious cardiapulmonary reactions

  Jamie Sheller | November 16, 2007 10:14 AM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  Reports of death and serious cardiopulmonary reactions to the micro-bubble contrast agents used with ultrasounds has caused the FDA to require revisions to the labels of these products. Micro-bubble ultrasound contrast agents are used in the administration of ultrasounds to view the heart. Definity and Optison are the only micro-bubble products approved for use in the USA. The adverse...

• Medtronic Recalls Sprint Fidelis Cardiac Leads

  Jamie Sheller | October 16, 2007 11:00 AM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  Medtronic has removed its Sprint Fidelis defibrillation leads from the market after several adverse events in patients. Defibrillators are used to monitor the heart rate in patients. If the defibrillator detects an irregular heart rhythm, it sends an electrical shock to the heart to restore normal rhythm. Medtronic has found that the leads are prone to fracture. These fractures may cause the...

• More Recalls of Guidant Heart Devices

  Jamie Sheller | April 12, 2007 12:36 PM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  Due to a defect causing shortened battery life, Guidant has recalled several models of its implantable cardiac defibrillators (ICD's) and cardiac resynchronization therapy defibrillators (CRT-D's). The recall involves about 73,000 devices, which have faulty capacitors possibly leading to rapid battery depletion. The Guidant ICD's and CRT-D's included in this recall are the Contak Renewal 3 HE...

• Kidney Disease Associated With Gadolinium-Based Contrast Agent

  Jamie Sheller | December 26, 2006 10:27 AM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  Recently, the FDA updated an earlier public health advisory concerning gadolinium-based contrast agents used with MRI and MR angiography procedures. There have been a number of reports of a new disease called nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NSD) occuring in patients with moderate to end-stage kidney disease. Some patients developed NSF/NSD after only one...

• Recall of Some Boston Scientific Guide Catheters

  Jamie Sheller | December 22, 2006 4:30 PM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  The FDA has recalled 12 lots of Boston Scientific's Mach 1 Guide Catheters. These devices are tubes that are thread through the body and used to help treat coronary artery disease. Excess strands of resin may be inside of some of the catheters. In the event that excess resin is present and detaches while the catheter is being used in treatment, embolization may occur. Embolization in a blood...

• Off Label Use of Drug Eluting Stents Carries Increased Risks

  Jamie Sheller | December 12, 2006 1:57 PM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  According to the FDA, off-label use of drug-eluting stents carries an increased risk of thrombosis, myocardial infarction and death. An FDA advisory panel recommended changing the labels of such stents. The two approved devices are Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting). Approximately 60% of the three million drug-eluting stents implanted in Americans, are off-label. In...

• Recall of Blood Clotting Test Strips

  Jamie Sheller | October 25, 2006 12:38 PM | 0 CommentsPhiladelphia, PA Category: Medical Malpractice
  

  Recently, Roche Diagnostics issued a recall of CoaguCheck PT test strips. Patients using anticoagulants or blood thinners have their blood tested to determine clotting time. The strips are used for that purpose, both by patients at home and by medical professionals. Depending on the blood clotting time, corrective measures may need to be taken. A defect in the CoaguCheck PT strips may cause...