Defibrillator Defined

Defibrillator refers to surgical equipment used for implantation procedure in patients who have certain heart illness that may develop as life-threatening heart arrhythmia or heart with abnormal rhythm. Defibrillators produce electrical shock to the heart to restore normal heart rhythm.

The Recall of the Guidant Defibrillator

The US Food and Drug Administration made a countrywide notification of recall in June 2005 of some Guidant implantable defibrillators and cardiac resynchronization therapy defibrillators. Boston scientific acquired the Guidant Corporation in April 2006.

The devices which were affected by the Notification of June 2005 are as follows:

• PRIZM 2 DR, Model 1861, produced on or before April 16, 2002
• CONTAK RENEWAL, Model H135, produced on or before August 26, 2004
• CONTAK RENEWAL 2, Model H155, produced on or before August 26, 2004

PRIZM 2 and RENEWAL equipments are subjected to various failures which may result to the inability of the devices to produce an electrical shock during episodes of arrhythmia. This malfunction may result to life-threatening event for a patient implanted with these equipments. FDA obtained reports of two deaths which were suspected linked with this malfunction.

Just recently, Boston Scientific made another recall on some defibrillators in June 2006, such as

• VENTAK PRIZM 2, VITALITY, and VITALITY 2 ICDs which are implantable cardioverter defibrillators
• CONTAK RENEWAL TR and TR 2 cardiac resynchronization pacemakers
• Certain Insignia and Nexus pacemakers

Boston Scientific/Guidant affirmed 5 reports of malfunction of equipment in some 27,200 patients all over the world, who underwent implantation procedure using these devices. One malfunction happened during the implantation process while 4 other cases involved patients who needed device replacement. Two of these cases, the patients have become unconscious when their equipment malfunctioned. However, there were no deaths that have been reported.

Recommended Action

The announcement made in June 2005, FDA advised the patients to follow these steps, if you might have been affected by faulty defibrillator:

• Call your physician to know if you have the affected product
• Keep your regular appointment with your doctor
• Call your doctor if you feel an electrical shock
• Contact your doctor or call emergency room right away if you hear an audible sound because it may be a sign that the device implanted to you is damaged

In a latest recall, Boston scientific sent notifications to doctors and patients to give them warning and advise that the patients should see their doctors soonest possible.

Obtaining Legal Help

It is the major obligation of the medical device manufacturer to produce products that are safe and inform the medical community and the general public about certain risks related with its medical device products. If the manufacturer fails to do this, they can be held legally liable if the patients are injured as a consequence of insufficient warnings or about the hazardous nature of the medical device, under a legal theory known as “product liability.”

If you or any of your family members who have underwent an implantation procedure with the Guidant defibrillator and are having any health problem, contact your doctor right away. Then, you may want to find a very good and experienced lawyer who will be able to discuss with you your options to safeguard your legal rights to remedy for any injury caused by Guidant defibrillator.