Simulations and benchtop testing were performed to assess potential gradient induced device heating of leadless pacemakers. Results of the evaluation showed leadless pacemakers sized objects, made from commonly used conductive materials, heated less than 1°C when exposed to the gradient induced device heating safety test conditions per ISO/TS 10974. In general, a temperature rise less than 2°C is considered to be clinically insignificant. As such, the risk of leadless pacemaker gradient induced device heating is negligible and assessments for this hazard per ISO/TS 10974 may not be necessary.
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