Guidant Says June Recommendation on Defibrillators May Increase Risk

INDIANAPOLIS (AP) — Guidant Corp. said Friday that one of the recommendations it made to physicians in June designed to correct a problem with its implantable defibrillators may actually increase risk to patients.

Implantable defibrillators are pacemaker-like devices that shock the heart back into a normal rhythm when it detects abnormal heartbeats. Guidant issued safety warnings on 11 models of its defibrillators last month, affecting about 88,000 implanted devices, because of malfunctions. The malfunctions occurred when a magnetic switch inside the device got stuck and prevented the device from providing treatment. The Food and Drug Administration classified that action as a recall.

Earlier this month, the company also issued safety warnings on nine pacemaker models. Guidant said Friday it has now changed its advice to doctors treating about 21,000 patients with implanted Ventak Prism AVT, Vitality AVT, and Contak Renewal AVT defibrillators. Originally, the company told doctors to make a certain programming change to the devices, which malfunctioned in two reported cases. However, the company found that a third event occurred after the original warnings went out despite the programming recommendation. The patient was not injured beyond having to have the device replaced. The company said it has now altered its programming recommendation to doctors as a result of the incident, but didn't elaborate on the change.

The company also said it is developing a noninvasive software change for its Vitality AVT and Renewal AVT devices that could be available in the fourth quarter, pending FDA approval.

Guidant, which has agreed to be acquired by Johnson & Johnson for $25.4 billion, said the FDA may consider this latest action as a recall.