Medtronic Defibrillator FAQ
A: A defibrillator is adevice that is surgically implanted in persons who have a type of heart diseasethat creates the risk of a life-threatening heart arrhythmia (abnormalrhythm). Defibrillators deliver an electrical shock to the heart torestore normal heart rhythm.
Q: Has there been any recent news about the Medtronicdefibrillator?
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, theU.S. Food and Drug Administration (FDA) announced that Medtronic, Inc. issued anotification regarding certain implantable defibrillatormodels. Medtronic voluntarily advisedphysicians about a potential battery shorting mechanism that may occur in asubset of implantable cardioverter-defibrillator(ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models.
Q: Which devices are affected by the February 2005notification?
A: The devices potentiallyaffected 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 andDecember 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 modelswith batteries manufactured after December 2003 are not affected.
Q: Have any deaths been reported as a result of adefibrillator malfunction?
A: Up until the time ofMedtronic's February 2005 notification, there had been no reported patientinjuries or deaths.
Q: What should I doif I have a Medtronic defibrillator implanted?
A: Medtronic recommends that patients implantedwith the affected devices continue to go for regular, routine follow-upprocedures; turn on the low battery voltage PatientAlertindicator; 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 isfunctioning properly.
Physicians are urgedto return all removed (explanted) devices to the manufacturer, regardless ofthe reason for their removal, in order to analyze these devices and todetermine if there has been any malfunction.
Q: What should I do if I think I have been injured by afaulty defibrillator?
A: If you or a loved one have been implanted with a Medtronicdefibrillator and are experiencing any unusual medical conditions, you shouldcontact your doctor immediately. You may also wish to meet with an experiencedattorney to discuss your options and to protect your right to a legal remedyfor any injuries caused by a Medtronic defibrillator. To find an experiencedattorney, use the "Find a Lawyer" tool on this page,or click here.