Medtronic Defibrillator Overview
What is a Defibrillator?
A defibrillator is a device that is surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). Defibrillators deliver an electrical shock to the heart to restore normal heart rhythm.
2007 Warning on Faulty Defibrillator Component
On October 15, 2007, defibrillator manufacturer Medtronic Inc. warned patients and health care providers that an electrical wire (called a "lead") that links the defibrillator to the heart could fracture. Medtronic announced that it is voluntarily suspending all distribution of the "Sprint Fidelis" leads. Medtronic defibrillators have included the Fidelis lead since 2004. According to a Press Release from Medtronic, Inc., the estimated 268,000 patients who have been implanted with Sprint Fidelis leads might experience lead fractures as "audible alerts, inappropriate shocks and/or loss of output," and the company has identified five deaths "in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor." Medtronic is not recommending replacement of the leads, because risks posed by implanting of a different lead are greater than risks presented by fracture of the Sprint Fidelis lead.
2005 FDA Medtronic Defibrillator Notification
In February 2005, the U.S. Food and Drug Administration (FDA) announced that Medtronic, Inc. issued a notification regarding certain implantable defibrillator models. Medtronic voluntarily advised physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models.
Medtronic reported that nine batteries have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function.
Up until the time of Medtronic's notification, there had been no reported patient injuries or deaths.
The devices potentially affected by the February 2005 notification are:
- MarquisTM VR/DR ICD
- MaximoTM VR/DR ICD
- InSync I/II/III MarquisTM CRT-D
- InSync III ProtectTM CRT-D
Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Approximately 75 percent of the above devices were implanted in the United States. Patients with other models or these models with batteries manufactured after December 2003 are not affected.
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Page last updated October 15, 2007
Some content from the U.S. Food and Drug Administration
