Are Cosmic Neutrons a Threat to Pacemakers? - Testing SRAMs with an Am-Be Neutron Source

Abstract

Introduction: Effects of cosmic radiation can impair pacemakers and other active implanted medical devices (AIMDs). There are several publications about devices showing irregular function during or after air-travel most likely caused by subatomic particles from space (Clair, Williams, Hygaard, & Saavedra, 2013; Ferrick, Bernstein, Aizer, & Chinitz, 2008; Paz, Teodorovich, Kogan, & Swissa, 2017). Furthermore, numerous radiation related malfunctions of unknown origin have been reported in the Manufacturers and User Facility Device Experience (MAUDE) database in recent years, some of which caused symptoms or led to the exchange of the device. These described malfunctions are most likely caused by SEE in the memory of the AIMD. Severe errors in the executed stimulation program are usually detected and corrected by the device itself through a power-on-reset. However, this procedure switches it to safety mode where stimulation parameters can be changed. Ultimately, this can lead to the pacemaker syndrome or unnecessary shocks of defibrillators. The problem of the susceptibility to particle radiation of medical devices is already well-known from radiation therapy. Therefore, various protective measures have been established for patients in recent years to avoid complications in this radiation environment (Gauter-Fleckenstein et al., 2015). Nevertheless, for developing and applying radiation protection measures to patients with AIMDs in further radiation environments, such as at aviation altitudes or during severe space weather events, the assessment of the risk of malfunction for AIMDs is necessary. [...]