Medtronic Defibrillator FAQ
Q: What is a defibrillator?
An implantable cardioverter defibrillator, or 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 or abnormal heart 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?
Yes, in October 2010 Medtronic settled existing U.S. lawsuits related to Sprint Fidelis defibrillation leads. However, this would not affect possible future lawsuits.
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.
In February 2005, the U.S. Food and Drug Administration (FDA) announced that Medtronic, Inc. issued a notification to doctors 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?
The devices potentially affected by the February 2005 notification are:
- MarquisTM VR/DR ICD (Models 7230 and 7274)
- MaximoTM VR/DR ICD (Models 7232 and 7278)
- InSync I/II/III MarquisTM CRT-D (Models 7277, 7279, and 7289)
- InSync III ProtectTM CRT-D (Model 7285, but none were implanted in the U.S.)
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?
As of 2014, there were no reported patient deaths from the defibrillators listed in Medtronic's February 2005 notification. However, the FDA had received reports of adverse events that included patient injury and hospitalization.
Q: What should I do if I have a Medtronic defibrillator implanted?
Medtronic recommends that patients implanted with the affected devices take a number of safety measures, including:
- Continue to go for regular, routine follow-up procedures;
- Turn on the low battery voltage Patient Alert 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, device tone will indicate that it is functioning properly.
Doctors are urged to return all removed 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?
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. To protect your legal rights, you may want to consult with an experienced attorney to discuss your options.
To learn more about an attorney's role in a defective medical device case, see the Get Legal Help with a Defective Product Injury article.