Advice
for Patients
with VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators
Guidant Corporation has recalled the above defibrillators because they can
develop an internal short circuit without warning, resulting in failure to
deliver a shock to the heart when needed. FDA is providing the following information
for patients and their families, so that they will be better able to discuss
treatment options with their doctors. We will update this advice if necessary
as more information becomes available.
Patients should understand that an FDA recall does not necessarily mean that
the device will be removed from the market or that the device needs to be removed
from the patient. Recall actions can also include correcting or modifying the
device.
The devices affected by this recall are:
- PRIZM® 2 DR, Model 1861, manufactured before April 16, 2002
- CONTAK RENEWAL®, Model H135, manufactured before August 26, 2004
- CONTAK RENEWAL® 2, Model H155, manufactured before August 26, 2004
These devices, called implantable cardioverter defibrillators (ICD)s, are surgically
implanted in people who have various forms of heart disease that create the
risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver
an electrical shock to the heart to restore normal heart rhythm. The device
malfunction results in the devices failing to deliver an electrical shock during
episodes of arrhythmia—which could lead to a serious, life-threatening
event for a patient. There have been two deaths reported to FDA that were associated
with this malfunction.
The exact percentage of these defibrillators that might experience a malfunction
isn’t known at this time. But the number of malfunctions reported so far
is very small compared with the number of devices in use, so it’s unlikely
that a patient will experience one of these events. Still, it’s important
for each patient to contact his or her doctor to discuss the best course of
action, including whether or not to replace the device. This decision will depend
on many factors, including the patient’s condition and medical history.
Replacing the device may be advisable in some cases, but in other cases the
risks associated with replacing the device, including the chance of infection
or injury during replacement surgery, may be higher than the risk that the device
will malfunction.
Advice for Patients
- If you’re not sure which model ICD you have, ask your doctor for this
information.
- If you have one of the affected models, contact your doctor promptly to
discuss the best course of action.
- Be aware that there is no way that you can test your device at home and
there may be no signal that your ICD has malfunctioned, so it is important
that you keep your regular doctor appointments.
- If you feel an electrical shock from your device, contact your doctor as
soon as possible.
- If you or others hear a “beeping” from your device, this may
signal a malfunction. Immediately contact your doctor or go to the nearest
emergency room.
Your physician has been notified of the problems associated with these model
ICDs and has received specific information about how to monitor your device.
FDA has been evaluating reported problems with the Guidant’s PRIZM®
2 and CONTAK RENEWAL® devices for several weeks and will continue to monitor
reports.
FDA and Guidant are working together to see that all physicians are notified
of the reported problems and receive accurate, up-to-date information. We are
also working with the clinical community through the Heart Rhythm Society and
patient advocacy groups to hear their specific concerns about this recall and
about recalls in general. Additional information about device recalls, questions
to ask your doctor about device recalls, and patient information about ICDs
is available at the Heart Rhythm Society’s website at http://www.hrspatients.org/patients/device_recalls/default.asp
Information FDA is providing to physicians about the ICD recalls is available
at http://www.fda.gov/cdrh/safety.html
Press Release: FDA
Updates Consumers on Guidant Corporation’s Implantable Defibrillators
Press Release: FDA
Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators
and Cardiac Resynchronization Therapy Defibrillators
FDA Preliminary Public Health Notification:: Guidant
VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators
October 13, 2005 Update to FDA Preliminary Public Health Notification: Guidant
VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators
December 28, 2005 Update to FDA Preliminary Public Health Notification: Guidant
VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators
Updated January 28, 2006
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