Defibrillator recall causes deadly gamble

Receiving repeated electrical shocks to the heart sounds like an unimaginable nightmare, but for many who trust technology to combat heart disease, it is reality.  In October of 2007, Medtronic, an ICD company that has been forced into recall by the FDA before, announced it had produced thousands of devices containing a faulty pacemaker lead.  In less technical terms, the wires in the pacemaker were found to break easily, causing patients to experience 800 volts of unnecessary electricity flowing through their bodies.  Broken leads can also ensure that the pacemaker will not deliver shocks when needed, causing emergency surgeries and sometimes death.

Why use defibrillators?

Invented in 1960, the implantable pacemaker/defibrillator is responsible for saving many lives.  A defibrillator is a small machine that monitors heart rhythm and releases an electrical shock to correct it.  Most people with pacemakers either have irregular heartbeats or are at high risk for a heart attack.  When the rhythm is abnormal, the pacemaker senses it and delivers a shock large enough to restart the heart, and hopefully save the victim’s life.  The pacemaker is attached to the heart with thin wires called leads.  When a lead breaks, it can mean pain and injury for the person wearing it.  Children and young adults are more likely to have broken leads because they are so physically active.

Medtronic and the FDA

The FDA approached Medtronic and questioned its production of pacemakers and defibrillators.  Medtronic suggested a voluntary recall, promising to inform ospitals, doctors, and patients of the dangers associated with its product, but it claimed that less than one percent of those with an implantable cardioverter-defibrillator would be affected.  In reality, the longer a lead is implanted, the more likely it is to break, so many more than one percent are affected.  If a hospital or doctor is still using recalled Medtronic devices, they are placing their patients in grave danger.

What to do about your pacemaker

For most patients, lead fracture risk is manageable without surgery.  A well-qualified doctor should be able to discuss with any patient both the option of keeping a Medtronic lead or removing it.  Dr. Alexander Petrakian of the Cardiovascular Associates of East Texas actually recommends that patients should speak to a physician, but should not have the pacemakers removed until they malfunction.  Medtronic and the FDA have both issued many statements about the products and their testing, but if you have had adverse affects from or simply have questions about your involvement with a pacemaker, contact an experienced attorney.