Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Implanta
24 Juin 2005 - 2:03PM
Business Wire
Guidant Corporation (NYSE:GDT) said today it is voluntarily
advising physicians about important safety information regarding
certain devices. Guidant apprised FDA of this action, and FDA may
classify this action as a recall. At this time, Guidant is in the
very early stages of a diligent evaluation of the component failure
described below. Guidant will continue its evaluation and
communicate further as more information is learned. As a
precautionary measure, physicians should discontinue implants of
these devices pending further notice. This communication advises
physicians and their patients of safety information and is intended
to limit adverse events. Physicians should use this information to
decide how best to treat their patients. The devices impacted are:
CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF Guidant
has determined that the devices listed above are subject to a
component failure that may limit available therapy. We have
determined that a magnetic switch in these devices may become stuck
in the closed position, which in some cases inhibits the device's
ability to treat ventricular or atrial tachyarrhythmias and can
accelerate battery depletion. Four occurrences have been confirmed
out of approximately 46,000 devices; a fifth occurrence is
suspected but cannot be confirmed. In the four occurrences in which
the device was implanted, patients and/or physicians were alerted
to the condition by audible device tones that signaled the magnetic
switch was closed. These four occurrences have resulted in device
replacement. One occurrence occurred prior to implant. To date,
there have been no patient injuries beyond device replacement. It
is Guidant's recommendation to physicians that they consider
programming "Enable Magnet Use" to "OFF" to ensure that appropriate
therapy to treat ventricular and atrial tachyarrhythmias will be
provided in the event that the magnetic switch becomes stuck in the
closed position. In addition, patients should contact their
physicians or go to the hospital emergency room immediately if they
hear tones from their device. Guidant continues to investigate this
issue and will provide any additional information that may help
physicians and patients. Guidant recently announced its intention
to establish an independent panel of experts to recommend
guidelines for when to disseminate information to physicians and
patients about life-sustaining implantable devices. Guidant plans
to cooperate with and enlist the support of other interested
parties, including the Food and Drug Administration, patient
advocates, and physician societies. 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.
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