Faulty Implantable Medical Device Causes Patient Fatality

This case involves the failure of a vagus nerve stimulator. The device was implanted in a child with severe epilepsy. Within two weeks, the child experienced several episodes with the device during which she was shocked by the device. Because of the episodes, the device was turned off, and the child soon became unstable and died. A biomedical engineering expert with experience designing implantable medical devices was sought to assess the device for a manufacturing defect.

Question(s) For Expert Witness

1. Have you worked in a design or engineering capacity relating to implantable medical devices?

2. Have you served as an expert involving a medical device failure?

Expert Witness Response E-065526

I have a keen understanding of the interaction between medical devices and the human body. Understanding the potentially dangerous side effects of these devices that are capable of producing electrical and electromechanical stimulation and the important balance of therapeutic effects has been part of my career for almost 20 years. I have Ph.D. and MD degrees in medicine, undergraduate and master’s degrees in electrical and biomedical engineering respectively. With my background in electrical and computer engineering and both industrial and academic experience with design of implantable medical devices, I believe I have a strong background to review this case. In my current profession, I educate students in the electronics of implantable devices, such as pacemakers, muscle stimulators, etc. While in industry, I worked on a number of proprietary projects that gave me significant experience using electrical engineering approaches in device design, implantable devices, and non-implantable device. Several models of the device in question underwent Class 2 Device Recalls due to delays in sensing during the use of the “verify heartbeat detection” feature. This recall was determined to be a Class 2 recall although the heartbeat detection controls the auto stimulation.