The reported adverse event is associated with a returned device; however, insufficient clinical information was provided by the clinic which made it impossible to establish the root cause of the issue.Hence, no specific device analysis is deemed necessary at this time.Should more information be made available at a later date, the decision could be reassessed.Per the clinic, the device was explanted on (b)(6) 2024.Additional information has been requested but has not been made available as of the date of this report.This report is submitted on april 5, 2024.
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