Guidant Defibrillator / Pacemaker
What is a Defibrillator?
A defibrillator is a device that is surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). Defibrillators deliver an electrical shock to the heart to restore normal heart rhythm.
Recall of the Guidant Defibrillator
In June 2005, the U.S. Food and Drug Administration (FDA) issued a nationwide notification of recall of certain Guidant implantable defibrillators and cardiac resynchronization therapy defibrillators. (Note: Guidant Corporation was acquired by Boston Scientific in April 2006.)
The devices affected by the June 2005 notification 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
The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia. This can lead to a serious, life-threatening event for a patient implanted with these devices. The FDA received reports of two deaths, which are suspected to be associated with this malfunction.
In June 2006, Boston Scientific issued another recall on certain defibrillators. Boston Scientific is recalling:
- Some Insignia and Nexus pacemakers
- CONTAK RENEWAL TR and TR 2 cardiac resynchronization pacemakers
- VENTAK PRIZM 2, VITALITY, and VITALITY 2 ICDs (implantable cardioverter defibrillators)
Boston Scientific/Guidant has confirmed five reports of device malfunction among some 27,200 patients worldwide, who have had these devices implanted. One malfunction occurred at the time of implantation, while, in the other four cases, the patients needed a device replacement. In two of these cases, the patients lost consciousness when their devices malfunctioned. No deaths have been reported.
In the June 2005 announcement, the FDA recommends taking the following steps, if you might be affected by a faulty defibrillator:
- Contact your doctor to determine if you have an affected product
- Keep regular doctor appointments
- Contact your doctor if you feel an electrical shock
- Go to your doctor or the emergency room if there is audible beeping, which is a sign that the device might be damaged.
In the more recent recall, Boston Scientific sent letters to doctors and patients, warning and advising that patients see their doctors as soon as possible.
Guidant Defibrillator - Getting Legal Help
A medical device manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of any known risks associated with its products. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the medical device, under a legal theory called "product liability."
If you or a loved one have been implanted with a Guidant defibrillator and are experiencing any unusual health problems or medical conditions, you should contact your doctor immediately. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by a Guidant defibrillator.