THE NEWS KEEPS GETTING WORSE FOR GUIDANT AS IT ANNOUNCES AN ADDITIONAL 46,000 DEFIBRILLATORS HAVE POTENTIALLY SERIOUS ELECTRICAL DEFECTSJun 25, 2005 | www.Newsinferno.com
On May 24, Guidant disclosed it had waited three years before disclosing it had been aware of an electrical problem that had caused some 28 of 28,900 Ventak Prizm 2 DR defibrillators to malfunction. One death that of a 21-year-old college student, was associated with this model.
As the story developed, the number of potentially defective defibrillators still in use reached almost 50,000; the 28,900 with the electrical problem and another 21,000 which could malfunction due to a computer memory error (the Vertak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICD). There had been 2 reports of failures associated with these other models. Neither report involved injury or death.
Then, a third problem came to light with respect to another potential short-circuit risk associated with the Contak Renewal (Model H135) and the Comtak Renewal 2 (Model H155). Out of those 16,000 devices, 15 reports of failures had been received including one involving a death on May 30. As a result, Guidant issued recalls for all of these devices on June 18.
Many experts openly questioned a monitoring system which essentially leaves the question of disclosure, with respect to potential flaws in such critical medical devices, entirely to the manufacturer. As a result, the Heart Rhythm Society will prepare a set of guidelines with respect to physician alerts and other actions that should be taken by defibrillator makers when they identify a pattern of malfunctions in the devices even if those failures are rare. The Society represents a branch of cardiology known as electrophysiology and is made up of cardiologists who specialize in implanting defibrillators.
Now, less than a week after the major recall, Guidant announced five more of its defibrillator models had a potential electrical defect (faulty switch) that could cause a malfunction. Those models are the Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF.
Guidant has advised doctors to stop implanting these devices until further notice. Currently, however, some 46,000 of them are already in use. Guidant acknowledged the FDA may classify this advisory as a recall. Although no deaths have been reported, as many as five devices have malfunctioned.
The FDA Advisory encourages patients with these defibrillators to discuss the matter with their doctor. Any adverse events or problems should be reported to the FDA at www.FDA.gov/medwatch/ or 1-800-FDA-1088. Additional information about this potential issue is available for physicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and http://www.guidant.com/physician_communications/RENEWAL3_RENEWAL4.pdf.