Other Side Effects of Guidant Implanted DefibrillatorsFREE Case Review
On June 17 th, 2005, the Food and Drug Administration issued a recall on Guidant brand Implantable Cardiac Defibrillators because of a potentially fatal flaw in the insulation of the wires in the control center of some models. In order to remedy this situation, and to prevent further fatalities and injuries, Guidant has ordered Prizm 2 DR and Contak Renewal models replaced, but encouraged patients with Prizm AVT, Vitality AVT and Renewal AVT to consult their doctors about reprogramming.
Replacing an ICD is not a simple process, and carries much risk. Surgery of this nature usually takes between one to three hours under general anesthesia, as a small computer about the size of a pager is inserted under the skin by the collarbone, and small wires are snaked into the lower chambers of the heart. Even though 99% of people survive the procedure, some do develop serious complications such as:
- Excessive bleeding
- Perforation of the heart muscle or lung
- Stroke or heart attack (myocardial infarction)
- Formation of a blood clot (hematoma) inside the skin
Doctors will always consider what is in the best interests for the patient, and sometimes this is removal and replacement of the device. If you have a model recalled by the FDA, you should contact your doctor and visit your nearest emergency room immediately.