<UPDATE>We are currently providing patients who have been injured by the Medtronic Sprint Fidelis Cardiac Lead or may need a Lead replacement in the future with recall information as well as evaluating if they may be entitled to significant financial compensation. Please complete the form to the left or call 1-800-214-1600.</UPDATE>
Urgent Class I Medtronic Sprint Fidelis Recall Notice
The FDA urged any patients who received a Medtronic Lead to seek immediate medical attention because the Medtronic Sprint Fidelis Lead malfunction has been associated with;
- Inappropriate Shocks which may Result in Death;
- Other Unusual Symptoms
Patients are urged to consult with their doctor whether the Medtronic Lead should be removed or replaced. This was a Class I recall placing it in the category of most serious recalls.
Click Here to see a list of the October 2007 list of Medtronic Sprint Fidelis Lead product that have been recalled.
What Doctors Can Do If You Have a Medtronic Sprint Fidelis Lead.
Patients should consider and discuss with their doctors alternative available which include;
- Removing the Medtronic Sprint Fidelis Lead through surgery;
- Continue to use the Medtronic Lead while monitoring closely for signs of fracture;
- Add a replacement lead. This does not require removing the Medtronic Sprint Fidelis lead. If the Spring Fidelis lead is left in the patient without being used, it must be “capped”, which means covering the tip with a small plastic insulation.
What is a Medtronic Sprint Fidelis Lead?
Manufactured by Medtronic, Inc., Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur.
How do defibrillators work?
Defibrillators monitor heart rhythms. They deliver an electrical shock or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected. These devices keep the heart from going too fast. They are surgically implanted for patients who are at risk of sudden cardiac arrest.
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