Defibrillators and Pacemakers
In September 2005, the FDA released results of a study on implantable cardioverter defibrillators (ICD) and pacemaker malfunctions.
| From 1990 to 2002, there were approximately 2.25 million pacemakers (PMs) and 416,000 ICDs implanted in the United States. During the same time period, 17,323 devices (8834 PMs and 8489 ICDs) were removed from patients due to confirmed device malfunction. ... [M]ore than 50% of the ICD malfunctions occurred during the last three years of the study. PM or ICD malfunctions were directly responsible for 61 confirmed deaths out of the nearly three million devices implanted during this time period. |
Defibrillator Recalls
Guidant has issued a Class I recall for some of their defibrillators. In a Class I recall, there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death. The FDA reported that "these devices can develop an internal short circuit when attempting to deliver an electrical shock to the heart, preventing the treatment of abnormal heart rhythms. The problem is caused by deterioration of electrical insulation in the device and can only be detected after the device has already malfunctioned. The device does not give any sign of impending failure and there is no test that predicts whether the device will fail."
Medtronic has also announced a Class I recall of some of their implantable cardioverter-defibrillators. "With the cardioverter-defibrillators in this recall, the capacitors may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or a non-delivery of shock therapy. Such a delay or non-delivery could result in patient injury or death because patients are not receiving the appropriate therapy in time."
We Can Help
If you have received a defibrillator or pacemaker that has malfunctioned, we can help. The Law Offices of Larry H. Parker has assembled a team of experienced product liability lawyers to handle your Guidant, Medtronic or St. Jude defibrillator or pacemaker case. For a free, confidential, no-obligation consultation, please fill out a form, send us an email, or call us at (800) 333-0000. Your call or email will only be handled by caring, understanding, and experienced case evaluators. Your confidentiality is guaranteed! Serving all of California, and now in Arizona with offices in Phoenix, Tucson, and Yuma. We’ll Fight For You!™
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