HeartMate II Pocket Controller Responsible for Four Deaths

 Posted on March 31, 2014 in Defective Medical Devices

Sometimes the medical devices meant to keep you alive are more dangerous than the condition they are meant to alleviate. When Thoratec introduced its HeartMate II monitor with pocket control, patients across the U.S. lauded the introduction as an easier way to deal with a debilitating condition. Yet in early March, the Thoratec Corporation “issued a safety advisory because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller,” according to the Food and Drug Administration (FDA) Safety Watch.

There were nine events that led Thoratec to issue the warning. Included in these nine were reports of four deaths and five incidents of unconsciousness and hypoperfusion. Two of the deaths, however, occurred in patients who attempted to change the device on their own without first contacting the hospital, as per the unit instructions. Yet even medical professionals were having trouble changing to the backup, which in part led to the other three deaths, according to the FDA.

HeartMate II is implanted to patients at severe risk of heart failure. The HeartMate II Pocket Controller, according to the Thoratec website, is the “only lightweight, pocket-sized LVAD controller that safely and smartly enables an active lifestyle for HeartMate II patients. Figures are not yet available as to how many patients have been issued the pocket controller, but according to Thoratec, there are approximately 15,000 patients who have had the HeartMate II implanted for the “long-term support of advanced heart failure.”

Because the defective behavior of the device is contingent upon its use and not its mechanics, the FDA has not recalled the device itself, but recommends that “consumers who have the HeartMate II LVAS Pocket Controller should immediately contact their doctor for retraining on use of the device and to receive updated Patient Handbook information.”

If you or someone you know has been negatively affected by the HeartMate II or any other medical device, the most important step is to seek the counsel of a Chicago attorney. Do not go through it alone. Contact Newland & Newland, LLP today.