Medtronics Recall 6931 Lead}

Medtronics Recall 6931 Lead

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John Humphrey

In October 2007, the patients and doctors were informed of the Medtronic recall of the Sprint Fidelis lead Model 6931. It was found that the Medtronic 6931 lead along with lead Models 6930, 6948 and 6949 were at risk of developing fractures in particular locations. As of October 2007, Medtronic was aware of at least 665 chronic fractures in returned Sprint Fidelis leads. The majority of these fractures (approximately 90%) have occurred in the anode or cathode conductors.

The Medtronic recall applies only to the leads and not implanted defibrillation or pacemaker devices. If a patient has one of the implanted leads their Patient ID card should contain one of the following four sets of numbers: 6930, 6931, 6948, 6949. These numbers may be part of a longer string of numbers on the ID card. Pacemakers help keep the heart from going too slowly compared to defibrillators which keep the heart from going too fast. The Medtronic Sprint Fidelis recall does not include Medtronic devices that are pacemakers. Patients who have Medtronic ICDs or CRT-Ds without Sprint Fidelis leads are also not affected by the Medtronic recall.

The 6931 Medtronic lead is a thin wire that connects an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. Defibrillators monitor a patients heart rhythms. They are surgically implanted for patients at high risk of sudden cardiac arrest. An electrical shock is transmitted or rapid pacing to restore normal rhythm when irregular heartbeats are detected. Defibrillators keep the heart from going too fast.

A total of 268,000 Sprint Fidelis leads were implanted in patients throughout the world, with 172,000 leads implanted in the United States. As of January 2007, approximately 5,387 Medtronic Sprint Fidelis Model 6931 leads had been implanted. Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms in patients which can cause the heart to suddenly stop. ICDs and CRT-Ds shock the heart back into normal rhythm by delivering a pulse of energy through an electronic wire (lead) that is connected to the heart.

Patients who have either received a Medtronic recall letter or have one of the lead recall Models listed on their patient ID card are urged to contact their doctors office with any questions about their leads. Doctors are encourage to analyze the risks versus benefits of either leaving the lead implanted along with careful monitoring or implanting a different lead model. Extraction of leads involves serious risks to the patient. Medtronics Independent Physician Quality Panel recommends that if one of the recalled leads (Medtronic lead 6931) requires removal, the surgery be performed by a doctor with extensive extraction experience.

It has been reported that doctors with limited extraction experience may significantly increase the risk of complications during extraction. Some of the reported complications of lead removal include: lead breakage and migration; avulsion of veins, myocardium of the tricuspid valve; tears of the myocardium or veins; hemothorax, tamponade, perforation, emergency cardiothoracic surgery, pulmonary emboli, and death. Lead extraction carries risks that need to be considered and discussed between the patient and their doctor. Published literature suggests major complications (death or surgical intervention) from lead extraction range from 1.4 7.3%.

Robert Whitney is author of this article on Medtronic lawsuits. Find more information about Medtronic lead recall here.

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Medtronics Recall 6931 Lead
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Family Doctors Cosmetic Surgery Destroys Wedding Plans}

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Submitted by: Dale Appell

Tampa, Florida February 23, 2011 Like any bride, Crystal Hill wanted to look fabulous for her wedding on February 12, 2010. So after losing 60 pounds from dieting and exercise, her girlfriends suggested liposuction so shed look her best for her big day and her new husband. Her girlfriends recommended Dr. Yves Jean-Baptiste because some of them had used him for liposuction procedures without complications. No one told Crystal Hill that Dr. Jean-Baptiste started doing liposuction procedures at his north Tampa family practice after completing a three day course in South Florida. Crytall Hill only became aware of that after reading an article in the St. Petersburg Times on August 7, 2010 entitled Limited training among some cosmetic surgery doctors worries state officials. According to the article, the Florida Board of Medicine recommended Dr. Jean-Baptistes medical license be suspended for one year and pay a $50,000.00 fine for allowing unlicensed assistants to perform liposuction procedures.

Crystal had reservations about having any type of cosmetic surgery, but with her approaching wedding and unattractive loose skin resulting from her weight loss, she decided to make the appointment. She first met with Dr. Jean-Baptiste on April 14, 2009 and felt comfortable with his recommendations because of her girlfriends successes and because Dr. Jean-Baptiste was board certified. Not until later would Crystal come to realize that there is a significant difference between board certification in family medicine which Dr. Jean-Baptiste was, versus board certification in plastic surgery, which he was not.

Dr. Jean-Baptiste performed two separate liposuction procedures on Ms. Hill. The first one went relatively well. The second one to her back side did not. Attorney Dale Appell in Tampa, Florida filed a lawsuit yesterday on Crystal Hills behalf and says, According to our expert, a board certified plastic surgeon, Mr. Hill was not an appropriate candidate for liposuction because even after losing 60 pounds, Crystals body mass index was still too high. During the surgery, the doctor removed too much fat tissue from Ms. Hill and infused too much fluid. This can traumatize the skin around the surgical site causing it to die and makes the patient more susceptible to infection.

And infection in the area of the liposuction is exactly what happened to Crystal. But rather than send Crystal to an infectious disease specialist, Dr. Jean-Baptiste and his staff attempted to treat the infection in his office by removing infected tissue from Crystal on almost a daily basis for approximately two weeks. During one of her last appointments, Dr. Jean-Baptiste sutured the large area with the infection still inside Crystal. Although Crystal grew increasingly concern about the infection and the way it was being treated, Dr. Jean-Baptiste appeared confident and then there was that Board Certification certificate on his wall. Because he was a board certified doctor, I trusted him too much, says Ms. Hill.

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Eventually Crystals fianc insisted Crystal see her primary doctor. Once her primary doctor unwrapped the bandages exposing the large area of infection, that doctor immediately admitted Crystal to the hospital, where the sutures were removed and the infection treated. Crystal cancelled her February wedding since she was still undergoing wound treatment several months after she was first admitted to the hospital. Crystal and her husband did eventually get married but without any family or friends present. Grateful to be alive after the ordeal, Crystal now lives with permanent and significant deformity of the surgical area. She also has a large area of irreversible and permanent scarring in addition to pain and a diminished range of motion.

Similar to the case mentioned in the St. Petersburg Times article, Ms. Hill believes that unlicensed assistants performed liposuction on her and that the reports failed to properly documented both the surgery and the treatment afterward. According to her attorney Mr. Appell, in addition to her lawsuit, Ms. Hill also filed a complaint with the Florida Department of Health. Its Ms. Hills hope that the Department and the Florida Board of Medicine will take appropriate action.

Contact Dale Appell, Esq. if you would like additional information at 813-877-3253 or dappell@wefightforjustice.com. An interview with Crystal Hill can be arranged as she seeks to bring awareness to the public of the issues regarding board certification, adequate training and cosmetic surgery.

Dale Appell

Personal Injury Law

3001 North Rocky Point Dr., Suite 200, Tampa, FL 33607

Phone: (813) 877-DALE (727) 866-DALE

www.wefightforjustice.com

dappell@wefightforjustice.com

About the Author: Dale Appell Personal Injury Law 3001 North Rocky Point Dr., Suite 200, Tampa, FL 33607 Phone: (813) 877-DALE (727) 866-DALE

wefightforjustice.com

dappell@wefightforjustice.com

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