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Sprint Fidelis defibrillator lead wire recall

Medtronic Inc. has had to go back to an old-reliable in the wake of last month’s Sprint Fidelis Defibrillator Lead recall. In order to continue to meet the demand for defibrillator lead wires, Medtronic has begun supplying health care providers with the Sprint Fidelis’ predecessor, the Sprint Quattro. The Sprint Quattro Defibrillator Lead is a thicker wire than the recalled Sprint Fidelis, and for some time before the recall, it was becoming apparent that the older Sprint Quattro model was safer than new Medtronic lead. Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 ... Read More

Did Medtronic act quickly enough on recall

Medtronic issued the recall of leads in October, amid mounting evidence that a small percentage of the leads were fracturing. Those fractures caused some patients to receive unneccessary shocks from their defibrillators, while other patients did not receive a lifesaving shock when they had a slow heart rhythm. The lead failures may have contributed to five deaths. At the time of the recall, Medtronic took great pains to underscore that the Fidelis leads had a 2.3 percent failure rate after 30 months of implantation. That compared to a 1 percent failure rate among the company’s Quattro leads, which have been ... Read More

Safety concerns over defibrillator wires

Shares of medical device maker St. Jude Medical could face pressure Monday on a media report that raised safety concerns over some of its defibrillator wires. The Wall Street Journal reported Monday that in rare instances, the company’s Riata line of defibrillator leads are poking holes through the hearts of cardiac patients rather than remaining attached to the heart wall. The leads connect a patients heart to an implantable defibrillator, which helps maintain a proper heart rhythm. The cases have been reported to the Food and Drug Administration. The newspaper said the most recent cases involve the accounts of four ... Read More

Shoulder pain pumps can result in lifetime disability

Post-Arthroscopic Glenohumeral Chondrolysis, or PAGCL, is a debilitating and life altering shoulder injury associated with intra-articular pain pumps used in conjunction with arthroscopic shoulder surgery. Shoulder arthroscopy is a rapidly expanding field because it offers a less invasive and less painful option for patients. In arthroscopy, two very small incisions are made, one for instruments and one for a miniature surgical camera to allow the surgeon’s viewing of the area without a large surgical site. To manage post-surgical pain and extend the deployment of numbing agents, the use of temporary intra-articular shoulder pain pumps was introduced into these types of ... Read More

Pain pumps can cause cartilage damage

Dr. Charles Beck, a well-respected orthopedic surgeon, recently issued a warning that a commonly used device designed to reduce pain after surgery is potentially dangerous when used in the shoulder joint space. The devices, manufactured by Stryker Corporation, I-Flow Inc. and other companies, deliver high concentrations of pain medication directly to a surgical site. According to the recently published article co-authored by Dr. Beck, they can cause permanent and debilitating damage to the shoulder. In discussing the matter, Dr. Beck stated: These devices have been used on thousands of patients nationwide, and based on our findings, hundreds appear to be ... Read More

Medtronic Sprint Fidelis leads facing more lawsuits

More lawsuits have been filed against Medtronic related to its defective Sprint Fidelis leads. Two Kansas residents have filed class action lawsuits alleging that Medtronic was negligent in the design of its Sprint Fidelis Leads. Both lawsuits also allege that Medtronic failed to warn patients about the possible defects in a timely manner. Back in March, Medtronic sent letters to doctors warning them about the risk of fractures in leads and reminding doctors of the proper way to use the leads. By this point, some doctors had already realized that the Sprint Fidelis leads were prone to fracture. However, patients ... Read More

Confusing new warning label on Avandia

If you take the popular diabetes drug Avandia, you should take notice at the new warning label. The FDA has strengthened the warning label on Avandia to include an increased risk for heart attack. But it may be a little confusing. Officials say the warning label will say that Avandia “may or may not” increase their risk of heart attack. The reason is that while short term studies have linked Avandia to an increased heart attack risk, longer term studies have been inconclusive. In the meantime, experts suggest that people with heart disease take something other than Avandia. November 15th, ... Read More

Two men sue company over design of defibrillator

Two area residents have filed federal class-action lawsuits over malfunctions they said could occur in Medtronic Inc. heart defibrillators implanted in more than a quarter-million patients. The lawsuits were filed against Minnesota-based Medtronic by Kenneth Carlile of Kansas City and Phillip S. Brown, a Johnson County resident. The complainants contend that Medtronic was negligent in its design of electronic wires – known as SprintFidelis leads – that connect the defibrillators to patients’ hearts. Medtronic in October voluntarily recalled the Sprint Fidelis wires because they can fracture, which causes them to give unnecessary shocks or not function at all. Medtronic said ... Read More

A patient an advocate a fixer

When it comes to her health, Laurel Lewis is positively fearless. The 54-year-old Minneapolis woman has stared down a rare breed of late-stage cancer. And last year, she technically died after her heart stopped beating, but luckily her near-fatal attack occurred just outside Fairview Southdale Hospital in Edina. She left the hospital with an implantable cardioverter defibrillator (ICD) made by Medtronic Inc. tucked inside her chest, a kind of medical-device insurance policy intended to shock her heart back into rhythm if she goes into sudden cardiac arrest. “I have faced the darkest day,” she said recently. But on Oct. 15, ... Read More

Kugel mesh patch a terrible ordeal

In 2003, when Janine Ryan’s (not her real name pending a lawsuit) mother, Sophia, had a Kugel Mesh hernia patch implanted, neither knew that there were any possible risks associated with the patch. But Sophia’s patch broke, causing her to experience severe pain and other serious problems. Like many other people, Ryan and Sophia are upset that they were never warned about the possibility of the Kugel Mesh patch breaking. In the spring of 2003, Sophia had a hernia operation in which the doctor used a Kugel Mesh patch to repair the hernia. Three years later, in the spring of ... Read More