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Guidant Pacemaker and Defibrillator Defect

Boston Scientific (Guidant) has alerted physicians to a defect in some models of the following pacemakers, and implantable cardioverter defibrillators:

  • INSIGNIA ®
  • NEXUS ®
  • CONTAK RENEWAL ® TR
  • CONTAK RENEWAL ® TR2
  • VENTAK PRIZM ® 2
  • VITALITY ®
  • VITALITY ® 2

On June 26, 2006, the FDA announced that Boston Scientific, which has recently acquired Guidant, is providing safety information to physicians and patients and retrieving some of the above models of Guidant pacemakers and Guidant defibrillators from its sales force and hospital inventories.

According to Boston Scientific, some low-voltage capacitors in the affected pacemakers and defibrillators may perform in a manner that leads to device malfunction, including intermittent or permanent loss of therapy or premature battery depletion. A capacitor is an electrical charge storage component.

According to the letter sent to physicians, “Guidant has confirmed five (5) reports of device malfunction associated with the failure of a low-voltage capacitor. Some capacitors can malfunction, causing intermittent or permanent loss of therapy or premature battery completion. One device malfunction was discovered at the time of implant, while four devices were implanted and subsequently required replacement. . . . There have been two reports of pacemaker patients experiencing syncope associated with loss of pacing output.”

According to the American Heart Association, “Syncope (SIN'ko-pe) is temporary loss of consciousness and posture, described as ‘fainting’ or ‘passing out.’ It's usually related to temporary insufficient blood flow to the brain. It's a common problem, accounting for 3 percent of emergency room visits and 6 percent of hospital admissions. It most often occurs when the blood pressure is too low (hypotension) and the heart doesn't pump a normal supply of oxygen to the brain.”

*On July 11, 2006, the FDA published an updated statement regarding the defective Boston Scientific/ Guidant pacemakers and defibrillators. Read the FDA updated statement.

Guidant Pacemaker and Defibrillator: Lawyer with Guidant Lawsuit Experience
Guidant has sent letters to patients regarding the pacemaker and defibrillator defect in the following:

  • INSIGNIA ®
  • NEXUS ®
  • CONTAK RENEWAL ® TR
  • CONTAK RENEWAL ® TR2
  • VENTAK PRIZM ® 2
  • VITALITY ®
  • VITALITY ® 2

If you received a letter from Guidant, a lawyer at Pritzker | Ruohonen, a nationally-recognized law firm, is available for a free consultation regarding your legal rights and remedies.  You may reach us toll-free at 1-888-377-8900, at info@pritzkerlaw.com,  or by filling out our online consultation form.

If a defective Guidant pacemaker or defibrillator was implanted in you, you may be entitled to compensation from Boston Scientific (Guidant). Damages sought against Boston Scientific (Guidant) could include compensation for physical and mental pain and suffering, medical and hospital expenses and punitive damages. Pritzker | Ruohonen has filed a lawsuit against Guidant and has the experience to help you.

Senior partner Fred Pritzker has over 29 years of experience and focuses his practice on complex product liability cases.  In recognition of his achievements, other lawyers have selected him for inclusion in the 2005-2006 edition of The Best Lawyers in America.  He has written online information on product liability and defective medical product lawsuits.

Sources:

Food and Drug Administration Announcement 
The American Heart Association


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