The reported event of back up mode following mri was confirmed.The device was not returned for analysis, however, abbott technical support did review session records.Based on the information received, the device event is consistent with the device entering power on reset (por) due to the mri settings not being enabled by the user prior to mri.The instructions for use (ifu) for this product include instructions indicating device programming is required for safe scanning and mri settings must be enabled before start of scan.
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