• Recall April 16, 2004
• Recall Feb. 25, 2005
• Recall April 22, 2005
• Recall Oct. 15, 2007
- Sprint Fidelis models:
- 6930, 6931, 6948, 6949
- Sprint Fidelis models:
• Irregular heartbeat
• Electric shock
• Extreme chest pain
What is a Medtronic defibrillator?
It is an implantable cardiac defibrillator.
Who uses it, and for what condition?
Patients suffering from tachycardia, irregular heartbeats, and fibrillation.
How does a Medtronic defibrillator work?
It is implanted on the heart and continuously monitors the heart to detect a dangerously fast heart rate. If it does, it sends a small, painless electrical signal to correct it. If the heart rate does not improve, the defibrillator delivers a life-saving shock to restore the heart to a more normal rate.
In 2007, Medtronic recalled the Sprint Fidelis lead used in its products because of their potential to fracture. More the 235 patients have these leads in their defibrillator.
If the lead has fractured, it could cause the device to fail, preventing the administration of life-saving therapy, or it could cause the device to shock unnecessarily. The manufacturer estimates that up to 5000 patients could have leads that experience some kind of failure.
Additionally, in 2004 Medtronic recalled two heart defibrillators—Medtronic Micro Jewel II Model 7223Cx and Medtronic GEM DR Model 7271—because they had been linked to at least four deaths and one injury. Medtronic said that some of these defibrillators have failed to charge properly which can result in the late delivery or no delivery of cardiac shock therapy.
What can you do?
If you are a defibrillator patient, you should contact your doctor immediately. Patients are being asked to come in for computerized testing that could detect abnormalities in resistance and other electrical functions that could signal an impending fracture in the lead. The identifying numbers for the leads in the Medtronic recall are 6930, 6931, 6948 and 6949.
If you have been injured by or have had a Sprint Fidelis lead implanted in you as part of an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillators — (CRT-D) you may have legal recourse against Medtronic. Please contact our firm either by telling us your story here or call us at: 1-888-341-1405.
Trust our Massachusetts products liability attorneys to help
Contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts defective medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case, and, perhaps, some hope.