Medtronic Defibrillator Causes Injuries and Death

Posted by Keith J. Ahlers - June 28, 2011 - C&A Blog - No Comments

When Medtronic, Inc. made the announcement that the wire connecting the Medtronic defibrillator to the heart, known as the Sprint Fidelis lead, could fracture inside a patient’s blood vessel causing a significant electrical jolt, many people began to panic.  There were at least five deaths reported in connection with this defective medical device and numerous injuries.  As a result, the product was recalled.

Heart defibrillators are used to monitor heart rhythms and will deliver an electrical shock or rapid pacing if necessary to the heart.  This medical device is able to detect irregular or life-threatening heartbeats.

Medtronic sent out a letter to physicians and patients regarding the Sprint Fidelis lead.  In the patient’s letter, the company stated that “the chance that there will be a problem with your Sprint Fidelis lead remains small.”  While this may be an accurate statement, according to Medtronic’s estimates, approximately 4,000 to 5,000 people with the Sprint Fidelis lead would most likely experience a fracture within 30 months of having the defibrillator implanted.  That number does not seem so small.

The electrical jolt from a defective Sprint Fidelis lead can cause extreme pain and death.  A faulty wire could also cause the defibrillator to beep or even more frightening, could deplete the defibrillator’s battery, meaning it would not be able to give the necessary shock to the heart that could save the patient’s life.

For patients with the affected Sprint Fidelis lead, the options are not ideal.  If the lead is removed, it can cause bleeding from torn veins and can also damage the heart.  Another option is that a new lead can be inserted into the vein and attached to the heart and the surgeon can then cap the old lead, but this procedure is also risky.