January 24th, 2008 amy
The Southeastern Texas Record reported yesterday that a Texas resident is claiming the unexpected shocks he received from his Medtronic Sprint Fidelis Lead wires caused him such severe anxiety that he is suffering from post traumatic stress and now requires psychiatric care. He filed a product liability suit against Medtronic on Jan. 18. […]
January 23rd, 2008 joshua
Stryker Corp. will participate in a voluntary recall of hip surgery parts after the Food and Drug Administration told the company it knew of complaints it received since 2005.
The Associated Press reports Stryker is recalling Trident PSL and Hemispherical Acetabular Cups that were made in its Cork, Ireland plant. Stryker said there are no safety […]
January 23rd, 2008 amy
Although they’ve yet to be approved by the FDA in the U.S., two new heart defibrillators made by Boston Scientific Corp have been approved in Europe. The defibrillators are the Cognis cardiac resynchronization therapy defibrillator and the Teligen implantable cardioverter defibrillator. The devices were designed to be small and lightweight with long battery life. […]
January 22nd, 2008 joshua
The New York Times is reporting many of the problems related to biliary stents derive from the alternative use of the medical device.
From 2003 through 2006, doctors have been using the stent, most commonly used to open bile ducts in patients, on clogged arteries in the torso and legs. More than a million patients have […]
January 22nd, 2008 amy
The Associated Press has reported that Michael Mastromarino, former owner of Biomedical Tissue Services, has agreed to talk to investigators about the companies that bought the stolen tissue in an effort to escape a lengthy jail sentence in cases in Philadelphia and New York. Mastromarino allegedly stole body parts from over 1,000 cadavers from […]
January 21st, 2008 joshua
The Stanford University Program in Biodesign seeks a way to improve the regulation and reporting of new medical devices to consumers. It recently published an article in the December 2007 issue of Journal of Medical Devices.
According to the report, the major hurdles faced in getting a new device from the lab to the patient stems […]
January 21st, 2008 amy
Over the weekend, Baxter Healthcare and the FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. Baxter is in the process of an in-depth investigation to determine the root cause of the reported reactions. […]
January 18th, 2008 amy
St. Jude Medical Inc announced Thursday that U.S. and European regulators approved its Durata high-voltage lead, a wire used to carry electrical currents in implanted defibrillator devices used to control rapid heartbeats. According to St. Jude, the Durata lead and the company’s equally thin Riata high-voltage leads are the smallest-diameter leads on the market. […]
January 18th, 2008 joshua
Patients who receive medication through an abdominal catheter which delivers medication at the site of chronic pain are experiencing uncomfortable and ironic side effects, the Web site injuryboard.com reports.
“Pain pumps” are causing a condition known as Postarthroscopic Glenohumeral Chondrolysis, a deterioration of cartilage surrounding joints. A typical “pain pump” patient suffers from spinal cord injury, […]
January 17th, 2008 joshua
Patients are forced to either decide to have lead replacement surgery, getting rid of the defective wires that connect to the defibrillator, or live with the defective device. The surgery is dangerous for those who rely on the device to live, but almost absolutely necessary.
Those who don’t absolutely require the defibrillator still face a risky […]
