Medtronic Defibrillator FAQ
Q: What is a defibrillator?
A: 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.
Q: Has there been any recent news about the Medtronic defibrillator?
A: 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. Read the Press Release from Medtronic, Inc.
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.
Q: Which devices are affected by the February 2005 notification?
A: 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.
Q: Have any deaths been reported as a result of a defibrillator malfunction?
A: Up until the time of Medtronic's February 2005 notification, there had been no reported patient injuries or deaths.
Q: What should I do if I have a Medtronic defibrillator implanted?
A: Medtronic recommends that patients implanted with the affected devices continue to go for regular, routine follow-up procedures; turn on the low battery voltage PatientAlert indicator; seek care if they experience warmth in the area surrounding the ICD; and use a hand-held magnet to monitor the device status periodically. A device tone will indicate that it is functioning properly.
Physicians are urged to return all removed (explanted) devices to the manufacturer, regardless of the reason for their removal, in order to analyze these devices and to determine if there has been any malfunction.
Q: What should I do if I think I have been injured by a faulty defibrillator?
A: If you or a loved one have been implanted with a Medtronic defibrillator and are experiencing any unusual medical conditions, you should contact your doctor immediately. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by a Medtronic defibrillator. To find an experienced attorney, use the "Find a Lawyer" tool on the left side of this page, or click here.
Most content above from the U.S. Food and Drug Administration
