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 or a prolonged fast heart rate, you should consult your doctor.
If my device is part of this notification, should it be replaced?
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.
If my doctor and I choose to have my device replaced, will Guidant provide a replacement device?
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.
Why is Guidant recalling some of their defibrillators?
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.
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.
If my device is part of this notification, should it be replaced?
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.
If my doctor and I choose to have my device replaced, will Guidant provide a replacement device?
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.
Why is Guidant recalling some of their defibrillators?
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.
Other Heart Device Litigation FAQs
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Q:
What are defibrillators?
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 … More -
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 … More -
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 … More -
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 … More -
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 … More -
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 … More -
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 … More -
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 … More -
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 … More -
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 … More
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