Effect of direct voltage induction by low‐frequency security systems on neurostimulator lead

Author:

Ardeshirpour Yasaman1ORCID,Cohen Ethan D.1,Seidman Seth J.1,Taddese Biniyam1,Zaidi Tayeb1,Bassen Howard1

Affiliation:

1. Office of Science and Engineering Laboratories Center for Devices and Radiological Health, US Food and Drug Administration Silver Spring Maryland USA

Abstract

AbstractLow‐frequency (LF) security systems, such as antitheft electronic article surveillance (EAS) gates emit strong magnetic fields that could potentially interfere with neurostimulator operation. Some patients reported pain and shocking sensations near EAS gates, even after they turned off their pulse generator. To investigate the direct voltage induction of EAS systems on neurostimulator leads, we evaluated voltages induced by two EAS systems (14 kHz continuous wave or 58 kHz pulsed) on a 40 cm sacral neurostimulator lead formed in a circular loop attached to a pulse generator that was turned off. The lead and neurostimulator were mounted in a saline‐filled rectangular phantom placed within electromagnetic fields emitted by EAS systems. The measured voltage waveforms were applied to computational models of spinal nerve axons to predict whether these voltages may evoke action potentials. Additional in vitro testing was performed on the semicircular lead geometry, to study the effect of lead geometry on EAS induced voltages. While standard neurostimulator testing per ISO 14708‐3:2017 recommends electromagnetic compatibility testing with LF magnetic fields for induction of malfunctions of the active electronic circuitry while generating intended stimulating pulses, our results show that close to the EAS antenna frames, the induced voltage on the lead could be strong enough to evoke action potentials, even with the pulse generator turned off. This work suggests that patient reports of pain and shocking sensations when near EAS systems could also be correlated with the direct EAS‐induced voltage on neurostimulator lead.

Publisher

Wiley

Subject

Radiology, Nuclear Medicine and imaging,Physiology,General Medicine,Biophysics

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