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Updated Guidant Defibrillator Information

• FDA Information on Guidant Defibrillator Failures and Fatalities
• Legal Rights and Remedies

News Update June 7, 2006 – Court documents in a Guidant defibrillator lawsuit suggest that Guidant knew about the electrical malfunction, yet kept selling the defective defibrillators.  One document was a letter that alerted doctors to the dangerous electrical malfunction. The letter was not sent, the defective defibrillators continued to be implanted.

Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Defibrillators: December 28, 2005, Update of FDA Preliminary Public Health Notification

The Food and Drug Administration (FDA) has updated information regarding the following Guidant heart devices:

• VENTAK PRIZM® 2 DR, Model 1861, manufactured on or before April 16, 2002,
  
• CONTAK RENEWAL®, Model H135, manufactured on or before August 26, 2004,
  
• CONTAK RENEWAL® 2, Model H155, manufactured on or before August 26, 2004.

These devices may develop an internal short and fail when it attempts to provide a defibrillation shock. This failure is a serious, life-threatening event. The new information from the December 28, 2005, FDA update is as follows:

• VENTAK PRIZM® 2 DR, Model 1861: There have now been a total of 32 clinical failures, including 2 patient deaths.
  
• CONTAK RENEWAL®, Model H135, and CONTAK RENEWAL® 2, Model H155: There have now been a total of 35 clinical failures, including 5 patient deaths.

According to the FDA, there are likely to be additional clinical occurrences in the future.

For more information, please see the following:

• The Full December 28, 2005, FDA Guidant Defibrillator Update;
  
• October 13, 2005, FDA Guidant Implantable Defibrillator Update;
  
• July 14, 2005, FDA Guidant Defibrillator Preliminary Public Health Notification;
  
• June 29, 2005, FDA Class I Recall of Guidant VENTAK PRIZM® 2 DR, Model 1861, ICDs (Updated July 18, 2005);
  
• June 29, 2005, FDA Class I Recall of Guidant CONTAK RENEWAL®, Model H135, and CONTAK RENEWAL® 2, Model H155, CRT-Ds (Updated July 18, 2005).

Legal Rights and Remedies
If a Guidant VENTAK PRISM® 2 DR was implanted in you or a loved one, you may be entitled to compensation from Guidant. Damages sought against Guidant could include compensation for physical and mental pain and suffering, medical and hospital expenses and punitive damages. Pritzker | Ruohonen has already filed a lawsuit against Guidant.

Attorney Fred Pritzker has 29 years of experience fighting for justice for injured people. His peers have recognized his achievements by selecting him for inclusion in the 2005-2006 edition of The Best Lawyers in America. Contact Fred Pritzker at 1-888-377-8900, email him at info@pritzkerlaw.com, or fill in the online consultation form. All consultations are free and confidential.

Pritzker | Ruohonen & Associates, P.A.
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Pritzker | Ruohonen & Associates, P.A.: Minnesota personal injury lawyers with a national
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