Guidant and Medtronic in the News

On March 14, 2005, Joshua Oukrop, a 21 year old college student from Minnesota died when his Guidant ICD (implantable cardioverter-defribrillator) malfunctioned due to an internal short circuit in his device.

Guidant had reportedly identified the problem back in 2002 but did not notify physicians or patients. Instead, they made changes to correct the problem but continued to sell their devices that were manufactured before the date the changes were made. Guidant did not inform the public about the flaw or the actions they had taken to correct the short circuiting error in their devices.¹ Joshua Oukrop’s doctors urged Guidant officials to alert other doctors but the company refused.²

In 2003, a Guidant subsidiary pleaded guilty to 10 felonies and paid $92.4 million to settle criminal and civil charges in a case involving a device that treated abdominal aortic aneurysms. Guidant had lied to the government and covered-up thousands of malfunction incidents, including 12 deaths.³

Guidant’s first announcement with respect to its defibrillators came on May 23, 2005. It came three years after they became aware of the problem and right before the New York Times was going to publish a story on Oukrop’s death.⁴

In July of this year, the American Food and Drug Administration classified Guidant’s notifications as either Class I recalls or Class II recalls.

Class I recalls are the most serious of recalls and are reserved for high levels of risk. The FDA issued the recall because for some Guidant devices;

“a seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.” ⁵

For some other Class I recalls, the Guidant

“devices can develop an internal short circuit when attempting to deliver an electrical shock to the heart, preventing the treatment of abnormal heart rhythms. The problem is caused by deterioration of electrical insulation in the device and can only be detected after the device has already malfunctioned. The device does not give any sign of impending failure and there is no test that predicts whether the device will fail.”

In three instances, the devices failed to work during normal routine check-up where doctors intentionally induce an abnormal heart rhythm. External defibrillators were required to rescue those patients.⁶ Approximately 60,000 Guidant devices are affected by the Class I recalls.

Class II recalls occurs when the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote. Approximately 21,000 devices could fail due to memory error. Another 46,000 Guidant devices could fail when the

“magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the device's ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion.” ⁷

In February of this year, Medtronic informed doctors that there was a potential for premature battery failure in their devices. There was a potential for the battery to short causing premature battery depletion. About 87,000 Medtronic devices are affected.

¹R. Steinbrook, “The Controversy Over Guidant’s Implantable Defibrillators”, The New England Journal of Medicine, 353:3, p. 221-224.
²B. Meier, “New Report of Problems at Guidant”, New York Times, July 30, 2005.
³R. Steinbrook.
⁴R. Steinbrook.
⁵http://www.fda.gov/cdrh/recalls/recall-071805.html
⁶B. Meier “Maker of Heart Device Kept Flaw From Doctors”, New York Times, May 24, 2005.
⁷http://www.fda.gov/oc/po/firmrecalls/guidant062405.html