Guidant: Original Fix For Defibrillators May Increase Risk
Company Updates Recommendations For DevicesJul 22, 2005 | AP Guidant is backtracking on some advice it gave to doctors last month concerning problems with its implantable defibrillators. The company now says the recommendations may actually increase risk to patients.
Contak Renewal 3 implantable defibrillator
Implantable defibrillators are pacemaker-like devices that shock the heart back into a normal rhythm when they detect abnormal heartbeats. On June 17, Guidant issued safety warnings on 11 models of its defibrillators because of malfunctions. That affected about 88,000 implanted devices.
The devices malfunctioned when a magnetic switch inside the device got stuck and prevented the device from providing treatment. Guidant has now updated recommended programming changes for the units.
The devices are:
VENTAK PRIZM 2 DR (Model 1861) ICDs manufactured on or before April 16, 2002
CONTAK RENEWAL (Model H135) and CONTAK RENEWAL 2 (Model H155) CRT-Ds manufactured on or before August 26, 2004
VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT ICDs (All series numbers)
Earlier this month, the company also issued safety warnings on nine pacemaker models.
For more information, contact Guidant at (866) 484-3268 or visit Guidant.com