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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

decorated veteran abuse victim

A daughter was horrified when she found that her 82-year-old father had been badly neglected while in a Florida nursing home. The WWII veteran entered the nursing home at the recommendation of hospice workers, due to serious lung problems and the inability to use his legs. They recommended the more constant care provided in a nursing home environment. Unfortunately, the man’s condition deteriorated in the facility due to apparent neglect. Anthony Vincent Digiannurio was eventually taken to the Florida Hospital DeLand by ambulance, where he was initially admitted for respiratory problems. However, after examining him, hospital staff were shocked to ... 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

$1 million neglect verdict

The family of an 84-year-old man who died while in the care of a Louisiana nursing home has been awarded $1 million in damages stemming from a nursing home neglect and medical malpractice lawsuit. Leon Nelms of Tallulah, La., died in November 2004 because of complications arising from neglect at Olive Branch Senior Care Center, the jury found. The 12-person jury rendered its verdict on Nov. 2. Shortly after entering Olive Branch Senior Care, Nelms had to be taken to a hospital because of infected pressure sores, weight loss, malnutrition and dehydration, the lawsuit alleged. He died six days later ... 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