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Guidant Defibrillator and Pacemaker - Advice for Patients

Did You Know?
Several patients implanted with its pacemakers have lost consciousness or developed possible heart failure, Guidant said, and one patient may have died due to a faulty pacemaker.

Advice for Patients

• If you're not sure which model ICD you have, ask your doctor for this information.
• If you have one of the affected models, contact your doctor promptly to discuss the best course of action.
• Be aware that there is no way that you can test your device at home and there may be no signal that your ICD has malfunctioned, so it is important that you keep your regular doctor appointments.
• If you feel an electrical shock from your device, contact your doctor as soon as possible.
• If you or others hear a "beeping" from your device, this may signal a malfunction. Immediately contact your doctor or go to the nearest emergency room.
• If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
• Continue to keep your regular doctor appointments.
• If you feel an electrical shock from your device, immediately contact your doctor.
• If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.

FDA Notifies Physicians on Guidant Reported Problems

Your physician has been notified of the problems associated with these model ICDs and has received specific information about how to monitor your device. The FDA and Guidant are working together to see that all physicians are notified of the reported problems and receive accurate, up-to-date information.

Physician Information: The FDA is providing to physicians information about the ICD recalls is available at:
http://www.fda.gov/cdrh/safety.html

Press Release: FDA Updates Consumers on Guidant Corporation's Implantable Defibrillators at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01198.html

Press Release: FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators at:
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01185.html

FDA Preliminary Public Health Notification: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators at:
http://www.fda.gov/cdrh/safety/071405- guidant.html

If you are in need of legal advice about your Guidant Defibrillator or Guidant Pacemaker, or simply wish to speak to an attorney who has experience with Guidant Recall in your state, you may use our Free Online Consultation Form.

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