Medtronic Recall

A safety alert was given in mid October of 2007 regarding the Medtronic Sprint Fidelis ICD leads. The leads, which connect the cardioverter defibrillator to the heart, have been found to fray and sever. These malfunctioning leads possess the ability to put you at risk of suffering from an unexpected cardiovascular event. The Sprint Fidelis ICD was introduced to replace the earlier mode, the Sprint Quattro.

Complications that have been reported regarding this ICD include:

• Sudden, unexpected death
• Malfunction of device
• Extreme pain or discomfort
• Cardiac events

Five deaths are allegedly related to the defects of these ICD leads. An estimated 270,000 patients have been implanted with the Sprint Fidelis model, concern has loomed regarding safety and efficacy of such leads since the first recall of related products in 2005. The offered replacement of the Sprint Fidelis is the Sprint Quattro, however, Medtronic does not have sufficient inventory to supply replacement ICD’s to all patients who have been implanted with the defective device. The entire amount needed to replace leads of affected patients will not be available until Spring of 2008.

The lead was engineered as a complimentary product to be used in conjunction with a cardioverter defibrillator. If the heart begins beating too rapidly in the event of a heart attack, or in the event a patient suffers full cardiac arrest, a shock is sent to the heart via and ICD lead to restore it to its normal rhythmic patterns.

If you have been implanted with this device, it may not be functioning properly. Those with concerns and questions regarding their ICD leads should seek medical attention immediately in order to avoid unexpected cardiovascular events. Patients should be well educated regarding their implanted defibrillators in order to provide medical personnel with that information should an emergency occur.