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