Guidant Defibrillator
Frequently Asked Questions
What you need to know about Guidant and Medtronic Heart Device Recalls.
Frequently Asked Questions on Guidant Heart Devices
- What are defibrillators?
- How do I know if I have one of these devices?
- What should I do if I have one of these devices?
- What is the appropriate follow-up period for my pacemaker?
- If I have one of these devices, what is the likelihood that my device will fail?
- What defibrillator models are being recalled?
- What should patients do if they are uncertain about their own Guidant defibrillator? Are there warning signs of defectiveness?
- Can I file a lawsuit for having a faulty defibrillator?
Frequently Asked Questions About Medtronic Heart Devices
- How do I know if I have a recalled Medtronic heart device?
- What should I do if I think I have an ICD or CRT-D device that could be affected?
- What if I don’t know my device model?
- What if I don’t know who implanted my device?
- Are these devices covered by a warranty?
- Do I need to have my device replaced?
- If I have one of these devices, is my life in danger?
- If I have a device that recently was implanted, should I be worried?
- Are any other Medtronic devices impacted? What about pacemakers?
Frequently Asked Questions on Guidant Heart Devices
A. 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.
Q. How do I know if I have one of these devices?
A. 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 the Guidant Web site: ( www.guidant.com/lookup)
- Contact Guidant Technical Services at 1-866-GUIDANT (1-866-484-3268)
Q. What should I do if I have one of these devices?
A. 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.
Q. What is the appropriate follow-up period for my pacemaker?
A. 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.
Q. If I have one of these devices, what is the likelihood that my device will fail?
A. 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 or a prolonged fast heart rate, you should consult your doctor.
Q. If my device is part of this notification, should it be replaced?
A. Only you and your doctor can make this decision. We have recommended to your physician that he/she consider increasing the frequency of your transtelephonic pacer checks or in-office visits to check your pacemaker. Additionally, for patients who are completely dependent upon their pacemaker, physicians have been advised to consider device replacement.
Q. If my doctor and I choose to have my device replaced, will Guidant provide a replacement device?
A. Many of these devices are nearing or have exceeded their estimated longevity and have thus outlived their warranty. Even if a device is no longer covered by warranty, Guidant will provide a replacement device at no charge for pacemaker-dependent patients and other patients deemed by their physicians to be best served by replacement, provided the replacement occurs prior to the normal appearance of elective replacement indicators. This supplemental warranty program is available through December 31, 2005. Additionally, Guidant will reimburse patients up to $2,500 for medical expenses remaining after Medicare and/or health insurance coverage, including device replacement or additional follow-up procedures.
Q. Why is Guidant recalling some of their defibrillators?
A. On June 17, 2005, Guidant Corporation recalled certain implantable defibrillators and cardiac resynchronization therapy defibrillators due to potentially fatal programming malfunctions of the devices. The recalled defibrillators were shown to develop an internal short circuit without warning, resulting in failure to deliver cardiac shocks when needed. When the required electrical impulses for treatment are not delivered to the heart, the heart can cease functioning, often resulting in patient death due to improper blood flow.
Q. What defibrillator models are being recalled?
A. 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 are subject to a memory error, which may affect therapy and device performance.
Q. What should patients do if they are uncertain about their own Guidant defibrillator? Are there warning signs of defectiveness?
A. 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 defibrillators do pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.
Signs of defectiveness are electrical shocks from the defibrillator, and an audible "beeping" from the CONTAK RENEWAL or RENEWAL 2 device. If either of these events occurs, immediately contact a doctor and go to the nearest emergency room, as these are indications that the defibrillator is damaged.
Q. Can I file a lawsuit for having a faulty defibrillator?
A. 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.
Frequently Asked Questions About Medtronic Heart Devices
Q. How do I know if I have a recalled Medtronic heart device?
A. 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 Marquis
- Model 7279 InSync III Marquis
- Model 7285 InSync III Protect (no devices implanted in the United States)
To clarify whether your device is in this group, please call your physician or the Medtronic patient toll-free line at 1-800-551-5544 (M-F, 7 a.m. - 6 p.m. CT) .
Q. What should I do if I think I have an ICD or CRT-D device that could be affected?
A. 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) .
Q. What if I don’t know my device model?
A. Please speak with your physician who follows the performance of your device. Or, call the Medtronic patient toll-free line at 1-800-551-5544 (M-F, 7 a.m. - 6 p.m. CT) .
Q. What if I don’t know who implanted my device?
A. If you don’t know who implanted your device, please call the hospital where your device was implanted. Or, call the Medtronic patient toll-free line at 1-800-551-5544 (M-F, 7 a.m. - 6 p.m. CT) .
Q. Are these devices covered by a warranty?
A. Your physician is in the best position to assess your individual situation and will work with Medtronic on any warranty needs.
Q. Do I need to have my device replaced?
A. Each physician will determine the best course of action for each individual patient.
Q. If I have one of these devices, is my life in danger?
A. This issue has been seen in just one (1) in 10,000 devices, and there have been no reported injuries or deaths related to this issue. All physicians who follow patients with these devices are being notified of the situation. If you have questions, contact your physician to discuss the situation.
Q. If I have a device that recently was implanted, should I be worried?
A. This potential issue does not affect individuals with devices with batteries manufactured after December 2003.
Q. Are any other Medtronic devices impacted? What about pacemakers?
A. No other Medtronic devices are impacted, such as pacemakers or other types of devices, because all other devices, including the listed models with batteries manufactured after December 2003, use different battery designs.