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MAUDE adverse event reports signal potential device issues; leaves open need for prospective confirmation before practice change.
As a service to our authors and readers, this journal provides supporting information supplied by the authors. Such materials are peer reviewed and may be re-organized for online delivery, but are not copy-edited or typeset. Technical support issues arising from supporting information (other than missing files) should be addressed to the authors. Appendix S1. United States Food and Drug Administration MAUDE database files representing reports of adverse events of implantable pulse generators demonstrating dysfunction post-MRI. Appendix S2. Destructive analysis reports generated by manufacturers after MRI anomalies leading to device replacement post-MRI, redacted for privacy purposes. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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Gimbel et al. (2015) studied this question.
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