Frequently Asked Questions
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What are defibrillators?
Defibrillators are small computer devices used to treat heart rate and heart rhythm abnormalities in patients who suffer from heart diseases. The devices are designed to be surgically implanted in the chest area and monitor cardiac function. Defibrillators can detect a heartbeat that is either too fast (tachycardia) or too slow (bradycardia), and delivers an electrical impulse or a series of shocks to various parts of the heart to restart normal function. more -
How do I know if I have one of these devices?
Guidant designs and manufactures three types of cardiac rhythm devices: pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Only a subset of pacemakers are included in this communication. To determine if your device is included among those described in this safety information communication, you can do one of the following: • Check your Guidant patient identification card for the model and serial number • Go to … more -
What should I do if I have one of these devices?
If you have questions or concerns, discuss them with your doctor. Your physician will consider your medical history and your dependency on your pacemaker to determine and discuss with you what is the best course of action. more -
What is the appropriate follow-up period for my pacemaker?
Your patient handbook recommends regular device check-ups. Your physician may advise you that additional follow-up visits might be necessary to more closely monitor your pacemaker. more -
If I have one of these devices, what is the likelihood that my device will fail?
Guidant's implantable devices continue to demonstrate extremely high performance and reliability. There is no way to predict if any device within this subset of pacemakers will fail, however, Guidant has provided physicians with recommendations to minimize your risk. Is there any way I can determine if my device has failed due to this issue? Implantable devices generally cannot be evaluated at home; however, if you notice any symptoms, like shortness of breath, dizziness, lightheadedness … more -
What defibrillator models are being recalled?
The Guidant defibrillators affected by this recall are: • 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 Guidant also recently informed the FDA that they are recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company reports the devices … more -
What should patients do if they are uncertain about their own Guidant defibrillator? Are there warning signs of defectiveness?
All patients who are currently implanted with a Guidant defibrillator are urged to seek immediate medical advice from their physicians to determine if they have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device. The FDA is not making a recommendation on whether individual patients who have Guidant defibrillators should have them removed and replaced, as this decision should be made based upon the specific medical situation of the patient. Removal and replacement of … more -
Can I file a lawsuit for having a faulty defibrillator?
Yes. Initially, Guidant indicated they would not cover the recall defibrillator replacements of more than five years old since they are off-warranty, but on the heels of the recent deaths attributed to the faulty defibrillators, Guidant has since changed their position. In fact, with the costs estimated at $25,000 per unit for each replacement defibrillator, Guidant could be facing compensation costs of as much as $225 million. more -
How do I know if I have a recalled Medtronic heart device?
This situation is limited to a group of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillator (CRT-Ds) incorporating batteries manufactured between April 2001 and December 2003 that were implanted in patients. Specifically, devices include: • Model 7230 Marquis VR • Model 7274 Marquis DR • Model 7232 Maximo VR • Model 7278 Maximo DR • Model 7277 InSync Marquis • Model 7289 InSync II … more -
What should I do if I think I have an ICD or CRT-D device that could be affected?
Please call your physician who follows the performance of your device to discuss the situation and their recommendations for your specific situation. Or, call the Medtronic patient toll-free line at 1-800-551-5544 (M-F, 7 a.m. - 6 p.m. CT) . more
