Philadelphia Personal Injury Lawyer - Medical Devices & Implants - Most Popular

Synthes Components Recalled

Jamie Sheller — Wed, 18 Nov 2009 21:17:38 GMT

Recently, Synthes, a Swiss medical device company, voluntarily recalled its Synex II Central Body components. According to the company, all surgeons and hospitals with the recalled devices were to immediately stop implanting them. The FDA has classified the recall as a Class I, which means that they could pose an imminent health hazard. The Synthes devices are used to replace damaged or unstable vertebral body in the T1-L5 portion of the spine. The recall was issued after reports of device failure causing loss of vertebral body replacement height. Those problems could lead to neural injury, increased pain and possible need for further surgery.

Originally posted at InjuryBoard by Jamie Sheller

Patients Suffering After Using Shoulder Pain Pumps

Jamie Sheller — Thu, 23 Apr 2009 14:55:54 GMT

Pain pumps are used after surger to help manage post-surgical pain. Recently, pain pumps used in the shoulders following arthroscopic surgery have been linked to postarthroscopic glenohumeral chondrolysis (PAGCL). Some patients are questioning the use of shoulder pain pumps by their doctors, in light of the extreme difficulties they have experienced. For instance, one woman can no longer perform her job as a home health aide. Due to her pain and continuing shoulder problems, she cannot help clients bathe and get dressed. In July 2008, Julie D. had surgery to repair torn cartilage in her shoulder. Her doctor sent her home with a pain pump, but after it was removed, Julie had continuous aching, with limited mobility, and she still had popping, clicking and grinding in her shoulder. Six months later, an MRI showed that the cartilage was re-torn and Julie had another surgery, with a pain pump being used for a longer amount of time. Since the most recent surgery, Julie has suffered with a constant ache from her shoulder to her wrist, and still has popping and clicking. Also, the pain medication has not taken care of the pain that she has. Julie is now questioning whether her post-surgical problems have been caused by the pain pumps that were used after both of her surgeries. She also wonders why her doctors used the pump in her shoulder when it is not approved for use in the joint. Her injuries have significantly impacted her day-to-day life. She is always in pain, and can no longer do many of the activities that she used to do. Julie also can't sleep comfortably. There are many people with similar suffering after use of shoulder pain pumps.

Originally posted at InjuryBoard by Jamie Sheller

Portable Headphones Can Cause Interference With Cardiac Devices

Jamie Sheller — Sat, 10 Oct 2009 17:11:24 GMT

According to a recent study published in the journal Heart Rhythm, the magnets in portable headphones may cause temporary malfunction of some cardiac devices. Therefore, the researchers suggest that patients with implantable cardioverter-defibrillators or pacemakers should not place headphones from MP3 players too close to their chests. The interference that can be caused by the headphones includes inhibition of tachyarrhythmia detection in ICDs and asynchronous pacing in pacemakers. Patients with these devices don't need to avoid portable headphones, they should just keep them at least 3 centimeters (1.2 inches) from their chests. Cardiac arrhythmia specialists have long told patients not to place electronic equipment directly over their devices.

According to the study's researchers, the FDA has already concluded that digital music players are unlikely to interfere with implanted devices, but not much was known about potential interference from portable headphones. In the recent study, electromagnetic levels from portable headphones exceeded levels sufficient to disable sensing in an implanted device, when the headphones were less than 2 centimeters from the chest. Most of the devices returned to normal functioning once the headphones were moved away. Patients with ICDs were more likely to have an interaction, than patients with pacemakers. The headphones' magnetic fields were the same whether the MP3 player was turned on, or the headphones were plugged in.

Originally posted at InjuryBoard by Jamie Sheller

Synthes Executives Indicted For Improper Marketing

Jamie Sheller — Sun, 21 Jun 2009 12:55:29 GMT

The United States Attorney in Philadelphia has indicted Synthes Inc. and four of its executives on federal charges. Synthes is a medical device maker, and according to the indictment, they improperly marketed it's bone filler, Norial XR for unapproved uses. The company is charged with conducting an unauthorized clinical trial, using the bone filler in two types of back surgery, called vertebroplasty and kyphoplasty. Three people died in the surgeries, though there is no proof that the deaths were caused by the bone filler. In vertebroplasty and kyphoplasty, a cementlike material is injected into a spinal fracture to repair it. However, the bone filler can escape and create a blood clot in the patient's system. In 2002, the FDA issued a warning of these risks after receiving reports of injuries and deaths. Though the FDA approved the bone filler for general bone repair, Synthes was not to promote it for spinal procedures.

According to prosecutors, Synthes allowed its salesforce to promote the bone filler for unapproved uses and misled FDA inspectors. The four indicted Synthes executives are charged with shipping unapproved medical devices. Those criminal misdemeanor charges carry a potential one year prison term. Usually the federal government files civil lawsuits for this activity, and it is rare for criminal charges to be filed against company executives.

If you have received a Synthes bone filler product, contact the lawyers at Sheller, P.C., 215-790-7300, to discuss whether you have a potential claim. Sheller attorneys work aggressively to represent people injured by defective medical devices. We have successfully obtained compensation for injured people from medical device manufacturers and pharmaceutical companies.

Originally posted at InjuryBoard by Jamie Sheller

Product Letter From Baxter Receives FDA Severe Urgency Level

Jamie Sheller — Wed, 18 Mar 2009 10:52:29 GMT

In January Baxter International issued a warning letter to customers regarding its Colleague Volumetric Infusion pumps. The pumps are used to deliver intravenous fluids and medicine to patients in hospitals. The Baxter letter warned that the Colleague pumps could fail and overheat. Failure codes in the products could cause the possible shutdown of the pumps. The FDA gave Baxter's warning letter its most severe level of urgency, because the shutdown of the pump is potentially fatal.

Originally posted at InjuryBoard by Jamie Sheller

Recall of Defibrillators

Jamie Sheller — Sat, 10 Oct 2009 15:55:21 GMT

Certain models of the HeartStart FR2+ brand of automated external defibrillator (AED), manufactured by Phillips, have been recalled. Recently, the voluntary recall was announced by the FDA. According to the FDA, the AEDs have a memory chip failure that can cause the device not to work. The AED is supposed to alert the defibrillator user when the patient needs a life saving shock. The AED determines when a shock is necessary by automatically analyzing the patient's heart rhythm. Between mid-2007 and early 2008, the memory chip failed some self-tests done by Phillips. There are no reported injuries from failed memory chips. Phillips will provide replacements for the recalled AEDs. The recalled AED models are the M3860A and M3861A, distributed by Phillips, and models M3840A and M3841A distributed by Laerdal Medical.

Originally posted at InjuryBoard by Jamie Sheller

Fetal Monitors With Inaccurate Readings

Jamie Sheller — Tue, 22 Sep 2009 21:41:41 GMT

The FDA has notified doctors and hospitals of reports that some Philips Avalon Fetal Monitors are producting inaccurate readings, most often during the second stage of labor. Philips issued an Important Device Safety Alert on September 4, 2009. If the inaccurate readings are not recognized and addressed, doctors may be unaware of fetal distress or may recommend unnecessary interventions based on false information. In order to avoid serious injuries, doctors must recognize the conditions and respond appropriately. The affected models are the FM20, FM30, FM40 and FM50 with the ultrasound transducer.

Originally posted at InjuryBoard by Jamie Sheller

FDA Gets Scolded By Public Citizen Over Baxter Pumps

Jamie Sheller — Wed, 18 Mar 2009 12:22:37 GMT

The FDA has recently come under fire from a consumer watchdog group. Public Citizen expressed anger at the FDA for its delay in evaluating the latest problems with Baxter International's infusion pumps. The pumps are used to deliver intravenous fluids and medicine to patients. Baxter sent a letter to customers in January, warning that its Colleague Infusion pumps could shutdown and overheat. Such problems are potentially fatal. Over six weeks after Baxter issued the warning letter, the FDA classified the announcement as a Class I recall, the agency's most severe warning. Though it is a serious warning, the Class I recall is not the same as a mandatory device recall, and therefore the Baxter pumps are not being pulled from the market.

According to Public Citizen, Baxter's Colleague pumps have been linked to 19 deaths, and have been the subject of seven FDA Class I recalls since 2005. Baxter claims that it stopped selling the pumps in the U.S. in 2005, but that 200,000 of the devices are still in use.

Originally posted at InjuryBoard by Jamie Sheller

Warning About Defective Medtronic Pacemakers

Jamie Sheller — Thu, 21 May 2009 13:58:19 GMT

There is a potential wiring defect in some Medtronic pacemakers. According to Medtronic, that wiring defect could cause a malfunction in 37,000 of its Kappa and Sigma pacemakers. Medtronic sent letters to physicians warning them that some of these pacemakers could run out of battery power or fail to respond when necessary. Medtronic advises doctors to consider removal of a pacemaker in this category that is required for daily survival. According to Medtronic there have been two reports of deaths that may be linked to the pacemaker. There are no programming fixes for this wiring defect. Also, Medtronic says that there are no tests to show which devices might fail. If a patient experiences fainting or lightheadedness, they should immediately call their doctor.

Originally posted at InjuryBoard by Jamie Sheller

Philadelphia Personal Injury Lawyer - Medical Devices & Implants - Most Popular

Synthes Components Recalled

Patients Suffering After Using Shoulder Pain Pumps

Portable Headphones Can Cause Interference With Cardiac Devices

Synthes Executives Indicted For Improper Marketing

Product Letter From Baxter Receives FDA Severe Urgency Level

Recall of Defibrillators

Fetal Monitors With Inaccurate Readings

More Problems with the Durom Cup Used in Hip Replacements

FDA Gets Scolded By Public Citizen Over Baxter Pumps

Warning About Defective Medtronic Pacemakers