According to Medtronic’s website, “Medtronic is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.” Medtronic manufactures cardiac resynchronization therapy defibrillators (CRT-D’s) and implantable cardioverter-defibrillators (ICD’s). These devices are used on patients with heart conditions and are surgically implanted into the chest. ICD’s work by monitoring a patient’s heart rhythm and shock the heart when the rhythm becomes abnormal to regulate the patient’s heart. CRT-D’s work in a similar fashion by sending electrical pulses to the heart under failure conditions.
On February 11, 2005, Medtronic released a public advisory warning physicians and users of a malfunctioning battery found in some of their ICD and CRT-D models. The faulty batteries rapidly deplete because of a shortening mechanism found in the batteries. Medtronic reported that less than .5% of the batteries tested had this shortening mechanism, but that the mechanism can cause a loss of function in the devices. A loss of function can cause serious injury to the device’s users but no patient injuries or deaths were reported at the time of the public advisory release.
Although Medtronic fulfilled its obligation to inform healthcare providers and users with information regarding their products’ potential risks and faults, court records show that Medtronic discovered the shortening mechanism in their batteries in early 2003 during routine testing. The FDA requires that a manufacturer must submit a report to the FDA “no later than 30 calender days” after it “become[s] aware of information, from any source, that reasonably suggests that a device [it] markets has malfunctioned and this device . . . would be likely to cause or contribute to a death or serious injury.” Despite their knowledge of the malfunctioning battery, Medtronic waited over 2 years to report their findings to the FDA. Medtronic’s faulty battery has led to several law suits against the company with plaintiffs seeking damages for personal injuries that resulted from their use of Medtronic’s devices.