What is a defibrillator?
Defibrillators are devices that send electrical energy to the heart of a person who is suffering from life-threatening heart problems such as arrhythmia or an abnormally-beating heart.
A Guidant Defibrillator is a kind of defibrillator that may be implanted in a person through surgery, which would then send therapeutic electric shocks to the heart to normalize the heartbeat.
Recall of the Guidant Defibrillator
The US Food and Drug Administration (FDA) gave a notification of recall nationwide for certain Guidant implantable defibrillators and cardiac resynchronization therapy defibrillators in June of 2005.
The devices that were recalled were:
CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
The RENEWAL and PRIZM2 have been reported to be prone to problems such as the devices’ failure to send electric shocks during the implanted person’s arrhythmia. Obviously this could be life-threatening for such person. Two deaths have been reported to be associated with the failure of these devices.
Boston Scientific, which acquired Guidant Corporation in 2006, issued a recall on some defibrillators:
CONTAK RENEWAL TR and TR 2 cardiac resynchronization pacemakers
Some Insignia and Nexus pacemakers
VENTAK PRIZM 2, VITALITY, and VITALITY 2 ICDs (implantable cardioverter defibrillators)
There are confirmed reports of the malfunction of Boston Scientific/Guidant devices, five out of among around 27,000 patients around the globe. Although no deaths were reported, the device malfunctioned during the time of implant. The other four needed replacement and two of those patients suffered loss of consciousness attributed to the malfunction of the devices.
In the FDA announcement in June 2005, it was recommended that people who may be affected should take the following steps:
- 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
Boston Scientific directly sent letters to patients and doctors to warn and advise them that patients need to see their doctors immediately.
Guidant Defibrillator – Getting Legal Help
Manufacturers of medical devices owe a duty to the users of their product to make their product reasonably safe as much as possible. They are obliged to let the public and medical community know if there are known risks to the use of their product. Inadequate warning or failure to warn will make the manufacturers liable for patients’ injuries as a result of using their product. This is called product liability.
If you or anyone you know have a Guidant defibrillator implanted in them and are showing signs of unusual health conditions or medical problems, it is advisable to speak with your or their doctor as soon as possible. You may want to consider consulting with an experience personal injury attorney to find out what options you may have in order to protect your legal rights and be entitled to a remedy for the injuries you have suffered.