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Abstract #1312

Impact of Implant Manufacturing Variability & Number of Measurements on Assessing RF-Induced Lead Heating & Injection Voltage

Carolyn Kwok1, Nowrin Chamok1, Arash Dabir1, Anasheh Avakians1, Kyle Bond1, and Louai Al-Dayeh1
1Boston Scientific, Valencia, CA, United States

Synopsis

Keywords: Safety, Safety, MR Conditional Implants, AIMD, DBS, SCS

Motivation: Establishing a validated predictive ISO/TS 10974:2018 Tier 3 model for RF-induced lead heating and injection voltage of an implantable medical device can be extensive and time-consuming.

Goal(s): Investigate the impact of lead manufacturing variability and number of in-vitro measurements on the resulting model’s Transfer Function scalar, A.

Approach: Lead heating or injection voltage was assessed for SCS and DBS systems for a varying number of samples and measurements and the resulting A values were compared.

Results: The impact on A was minimal and as few as six measurements of one lead sample can develop a reliable model.

Impact: Optimization of the needed number of in-vitro radiated measurements and active implantable medical device (AIMD) lead samples for ISO/TS 10974:2018 Tier 3 based Clause 8 (RF-induced lead heating) and Clause 15 (RF-induced injection voltage) MR Conditional safety assessments.

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