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.
- Press Release from Medtronic, Inc.
- Important Patient Information on Sprint Fidelis Leads from Medtronic, Inc.
- FDA Statement on Medtronic Announcement
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.
Medtronic recommends that patients implanted with the affected devices:
- 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
- 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.
Medtronic Defibrillator - Getting Legal Help
A medical device manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of any known risks associated with its products. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the medical device, under a legal theory called "product liability."
If you or a loved one have been implanted with a Medtronic defibrillator and are experiencing any unusual health problems or 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.