Defective Medical Devices: Medical Negligence: Pacemaker and Defibrillator Defects
Medtronic, St. Jude, Boston Scientirfic/Guidant Pacemakers & Defibrillators

Pacemaker & Defibrillator Recall List *

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Patients Warned as Maker Halts Sale of Heart Implant Part

by: The New York Times | Barnaby J. Feder

October 15 , 2007

The nation’s largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component in its most recent defibrillator models because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths. (read entire story)


Guidant / Boston Scientific, St. Jude and Medtronic Pacemakers and Defibrillators have been the subject of various product safety issues and recalls. The Food and Drug Administration (FDA) has provided updates on these pacemakers and implantable defibrillators made by Guidant, Medtronic and St. Jude.


Guidant/Boston Scientific Pacemakers and Defibrillators must be monitored by physicians with follow-up exams of patients as a result of these risks. Certain models of these pacemakers and implantable defibrillators have been recalled .

Problems related to these pacemakers and implantable defibrillators may include device failure relating to battery depletion and other problems associated with adverse cardiovascular events and unfortunately many deaths among patients.


Defective Guidant Defibrillators Continue to Haunt Boston Scientific

Date Published: Monday, September 11th, 2006
Article Posted by NewsInferno

According to recent SEC filings, Boston Scientific Corp. now faces about 477 individual and 72 class-action lawsuits over recalled Guidant defibrillators. Boston Scientific purchased Guidant earlier this year for $27 billion, after outbidding Johnson & Johnson. Both companies pursued Guidant even though the company had just recalled thousands of defibrillators and pacemakers. J&J's decision not to match the higher offer appears to have been fortuitous, as Boston Scientific has already reserved $381 million to fund Guidant related lawsuits, and some legal experts believe the company's liability could actually be much greater.

The first trial surrounding defective Guidant defibrillators is set to begin in Corpus Christi, Texas on September 18, 2006. The plaintiffs in this are two patients who had Guidant's Ventak Prizm 2 defibrillator implanted 2001. While both plaintiffs are still alive, they live with the fear that the devices can fail at anytime. Many patients in their same situation have elected to have the defective devices removed and replaced with new models. The removal and insertion of these devices does require risk, making it a difficult decision for patients to decide on the best course of action.

Plaintiffs argue that Guidant knew about the defects in their defibrillators for three years before they informed doctors about the problems. The defibrillator defects didn't come to light until the death of a 21-year-old college student was reported. The student had a Guidant defibrillator implanted because he suffered from heart disease. Guidant acknowledged that the defibrillator short circuited causing his death. The company also told his doctors that it was aware of 25 other cases in which the defibrillator had been affected by the same flaw. However, Guidant's executives said the company did not see a compelling reason to issue an alert to physicians because the unit’s failure rate was very low and replacing the devices might pose greater patient risks.

The Guidant defibrillator recall included the following models: Guidant Prizm 2 DR, Model 1861, Guidant Contak Renewal, Model H135, Guidant Contak Renewal 2, Model H155, Guidant Prizm AVT Vitality AVT Renewal 3, Guidant AVT Renewal 4 AVT, Guidant Contak Renewal 3 and 4, Guidant Renewal 3 and 4 AVT and Guidant Renewal RF.

The recalled defibrillators are known as implantable cardioverter-defibrillators or ICD's. These devices are implanted under the skin of patients to manage sudden cardiac death due to ventricular fibrillation. ICD's are used to treat patients at risk of recurrent, sustained ventricular tachycardia or fibrillation. When an ICD detects ventricular tachycardia or fibrillation, it shocks the heart to restore the normal rhythm. When working properly, ICD's have been very useful in preventing sudden death in patients with known, sustained ventricular tachycardia or fibrillation. New studies are being conducted to learn if ICD's can be used to prevent cardiac arrest in high-risk patients who haven’t had, but are at risk for, life-threatening ventricular arrhythmias.

It is important to speak to an attorney about the injuries you may have incurred from the Pacemaker or Defibrillator that may have malfunctioned as the result of the recall defect. Our lawyers can provide you with a free consultation and help you understand what your rights are and if you have a claim against the manufacture of the medical device. click the 'free consultation' button to fill out our online web consultation form, one of our attorneys will contact you promptly to assist you.

The litigation process of getting the compensation for your injuries you deserve can be a painful process. However, you don't have to go through that fight alone, The Sanders Law Firm is on your side. contact us today.

 


Guidant Issues Implant Warning

Published: March 14, 2006
Posted by The New York Times

The Guidant Corporation said yesterday that it was warning doctors of battery problems in two models of implantable devices used to treat heart patients.

Guidant said the problems were in its Contak Renewal 3 RF and Renewal 4 RF cardiac defibrillators.

None of the devices that have the problem were implanted in patients, the company said.

Guidant, which is set to be acquired by the Boston Scientific Corporation next month, said it had received 39 reports of lower-than-expected battery voltage in the devices, which manage errant heart rhythms.

There were no reports of abnormal battery voltage in the approximately 4,000 Renewal 3 RF and Renewal 4 RF devices that have been implanted, the company said.

''This only impacts devices in the box and can be corrected with a simple programming solution,'' a Guidant spokeswoman, Annette Ruzicka, said. ''Implanted devices are not impacted.''

Guidant, which is based in Indianapolis, said the Food and Drug Administration might classify its notification to physicians as a product recall.

 


 

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