Guidant Corporation produces implantable cardioverter defibrillators, which are physically implanted in the patient in order to provide an electric shock to the heart in an effort to normalize the heartbeat when the patient is experiencing an irregular heartbeat episode.
Guidant Corporation discovered that a large number of their defibrillator models were frequently short-circuiting, seriously impacting the survival of the patient experiencing an irregular heartbeat episode. For three years after Guidant Corporation knew that the medical device could short-circuit, they failed to inform doctors or patients about the defective defibrillators. As of October 2005, there have been 21 reported cases of defibrillator failures and three deaths due to defective defibrillator short-circuit problems worldwide.
Guidant Corporation released a warning and recall for the following defibrillator models:
· VENTAK PRIZM 2 DR, Model 1861, if manufactured by Guidant Corp. on or before the date of April 16, 2002
· CONTAK RENEWAL, Model H135, if manufactured by Guidant Corp. on or before the date of August 26, 2004
· CONTAK RENEWAL 2, Model H155, if manufactured by Guidant Corp. on or before the date of August 26, 2004
The medical device and defibrillator community was made aware of the possibility for certain models of Guidant Corporation's defibrillators to fail during a patient's irregular heartbeat episode, when a 21-year-old college student died due to a failure in his VENTAK PRIZM 2 Dr, Model 1861 cardioverter defibrillator.
Critical corrections were made to the VENTAK PRIZM 2 DR, Model 1861 in April and November 2002. Even after essential modifications were made to the VENTAK PRIZM 2 DR, Model 1861 cardioverter defibrillator, Guidant Corporation continued to distribute cardioverter defibrillators made before April and November 2002, without the critical corrections.
The U.S. Food and Drug Administration has stated that patients with Guidant heart defibrillators immediately make an appointment to meet with their doctor, especially if the patient is unsure about whether or not their defibrillator is one of the models included in Guidant Corporation's defibrillator recall. They have also recommended that heart defibrillator patients seek the advice of an electrophysiologist.
If you or a loved one have been injured due to a defibrillator, contact The Sumner Law Group today to seek legal action.