St. Jude Implantable Cardiac Defibrillators
The Food and Drug Administration (FDA) approved the first cardiac implantable defibrillator (ICD) over 10 years ago. ICDs are designed to shock a heart with an abnormal beat back to a normal rhythm, but defects have caused some devices to malfunction, leading to injuries and even deaths.
St. Jude Medical is the third largest medical device maker in the US and is located here in St. Paul, Minnesota. On June 21, 2005, St. Jude first alerted doctors and federal regulators about a defect in some of its ICDs that could cause the device to malfunction. St. Jude discovered what it called two "anomolies" while doing a routine evaluation of its products. First, in ICDs past their mid-life, the device might skip a series of shocks necessary to revitalize a patient's heart. Second, the device's pacing rate could be temporarily increased. The FDA approved St. Jude's proposed software upgrade to fix the defects. The software upgrade required a non-invasive procedure where new software would be downloaded into a patient's device. This news affected about 39,000 patients worldwide with the following devices: Epic DR/HF, Models V-233/V-337/V-338; Epic Plus DR/VR/HF, Models V-236/V-239/V-196/V-239T/V-196T/V-350; Atlas DR, Model V-242; and Atlas Plus DR/VR/HF, Models V-243/V-193/V-193C/V-340/V-341/V-343.
On October 6, 2005, St. Jude alerted doctors about another defect in its ICDs that could cause device malfunctioning. A memory-chip supplied by a particular vendor could be affected by "background cosmic radiation". This defect could cause the temporary loss of pacing and permanent loss of defibrillation support, causing the device to fail. St. Jude reported 60 cases of this failure in the 36,000 devices implanted worldwide. St. Jude claims that 26,000 of these devices are still in service. The affected devices include: Photon DR, Model V-230HV(certain serial numbers); Photon Micro VR, Model /DR, Models V-194/V-232; and Atlas VR/DR, Models V-199/V-240. To find out if your St. Jude device serial number is recalled, contact one of our attorneys at Goldenberg & Johnson toll free at (800) 279-6386.
Individuals who have a defective device may be able to file a lawsuit against St. Jude. If you or a loved one has been injured by a St. Jude ICD, the attorneys at Goldenberg & Johnson can answer any questions and discuss your potential case. You can speak to one of our attorneys by calling toll free (800) 279-6386.
