Defective Products - Guidant and Medtronic Defibrillators
Columbus, Ohio
Many people with heart disease rely on implantable defibrillators and pacemakers (also called cardiac resynchronization therapy defibrillators). These surgically implanted devices deliver life-saving shocks that can resynchronize the heart during episodes of arrhythmia, which might otherwise be fatal.
However, recent reports show that many of the implantable defibrillators distributed by medical device manufacturers Guidant and Medtronic have serious defects that can lead to failure. These defibrillators can short circuit without warning, and fail to deliver the necessary electrical shocks during an arrhythmia. In at least two reported cases, patients have died as a result of these defective devices.
Medtronic defibrillators
In response to reports of device failures, Medtronic has issued advisories on several of its defibrillators, and Guidant has issued recalls on several models.
The Medtronic devices with issued advisories include the following implanted cardioverter-defibrillators (ICD) and cardiac resychronization therapy defibrillators (CRT-D) models:
- Marquis VR/DR ICDs
- Maximo VR/DR ICDs
- InSync I, II, and III Marquis CRT-D
- InSync III Protect CRT-D
These models have been shown to be susceptible to shorting, which can cause the batteries to deplete rapidly and the defibrillators to stop functioning. The advisory only includes models with batteries manufactured between April 2001 and December 2003.
Patients with this type of defibrillator are advised to talk to their doctors to ensure that their implantable defibrillators are functioning properly, and to discuss their treatment options.
Guidant defibrillators
Several models of implantable defibrillators manufactured by Guidant have also reported failures due to device defects.
The affected defibrillators have been recalled by Guidant. Reports suggest, however, that the company may have withheld information about these serious flaws for years before the recall was issued, putting many patients at risk of injury or death.
The Guidant defibrillator models affected by the recall include:
- Prizm 2 DR
- Contak Renewal
- Contak Renewal 2
- Ventak Prizm AVT
- Vitality AVT
- Renewal 3 AVT ICDs
- Renewal 4 AVT ICDs
According to the manufacturer, the flaws that can cause these devices to fail are present only in defibrillators manufactured before 2002 in some cases and 2004 in others.
If you or someone you love has one of the affected models of Guidant defibrillators implanted, notice of a recall should have been received. If you are not sure whether your device is affected by the recall, then you should discuss the matter with your physician as soon as possible.
If you have a faulty defibrillator
If you have concerns about your implantable defibrillator, your first step should be to talk to your doctor and determine whether your device is one of the affected models. If you determine that your device is an affected model, you should discuss your treatment options with your doctor. Your next step should be to contact Robert W. Kerpsack, Guidant defibrillator Lawyer in Ohio, who has experience with lawsuits against medical device manufacturers.
Call or email Robert W. Kerpsack, Co., L.P.A., to schedule your free personal consultation.
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