MRI Gradient Induced Vibration of Leadless Pacemakers

Simulations were performed to assess potential gradient induced vibration of leadless pacemakers. Results of the evaluation showed leadless pacemakers sized objects, made from commonly used conductive materials, generated very small vibrations (all less than 0.3mm in displacement) when exposed to conservative gradient induced vibration safety test conditions per ISO/TS 10974. These calculated displacements are negligible in comparison to the interacting displacements between a typical leadless pacemaker and cardiac tissue through each cardiac cycle. As such, the risk of leadless pacemaker gradient induced vibration tissue damage is minimal and assessments for this hazard per ISO/TS 10974 may not be necessary.