My Healthy Heart Blogs
Medtronic Suspends Implantable Cardioverter Defibrillator
10/25/07
From a U.S. Food and Drug Administration news release.
Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.
Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today's action.
Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.
When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. It is unknown if this rate of adverse events will remain constant or increase over the life of these leads. Some deaths and major complications have occurred after the leads have fractured.
While the FDA has designated Medtronics actions as a product recall, the defibrillators do not have to be surgically removed and returned to the manufacturer. Medtronic has advised physicians to program the defibrillators to sound a warning beep if the lead begins to fail. If patients hear the warning, they should contact their physician immediately.
For more information, visit the Medtronic Web site and read its statement.
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