The Boston Scientific Co. has issued a warning to doctors that another 996 defibrillators made by its Guidant unit may be defecitve, placing receiptents of the deivice at high risk for sudden cardiac death.
No deaths or injuries have been linked to the battery failures, the Natick, Mass.-based company said Monday. The defect, a faulty low-voltage capacitor, was confirmed in 30 defibrillators removed from patients as of May 8, and is suspected in at least 46 devices still implanted, Boston Scientific said. The Guidant division that makes the defibrillators is based in Arden Hills.
The defibrillator models affected are the Vitality DS, Vitality AVT, Vitality 2, Contak Renewal 3 and 4, and the Contak Renewal 4 AVT. The products were manufactured in March 2005 and all used a capacitor from a single supplier. , Guidant has advised doctors to schedule in-clinic appointments for patients as soon as possible to check the batteries of those devices.
Defibrillators are devices implanted in the chests of heart-failure patients and wired directly to hearts to keep them from suddenly stopping, thus halting the circulation of blood throughout the body. When the device senses an abnormal heart rhythm, it fires high-voltage electrical pulses to restart the heart.
The failure of these devices was learned by Boston Scientific Co., after purchasing Guidant Corp. on April 21. Last December, U.S. regulators sanctioned Guidant due to a recall of 109,000 defibrillators which were linked to several deaths. Researches have said that up to 400,000 people in the U.S. who die of sudden cardiac death each year could be helped by defibrillators, and some have estimated the potential market as 1.6 million patients.
Boston Scientific stated in a corporate filing last week that it is defending 306 defibrillator lawsuits and expects the number of claimants to reach 3,000. The first federal trials are expected in 2007.