Per the clinic, the patient developed an infection at the implant site and subsequently was treated with oral antibiotics.The patient was hospitalized due to the infection and underwent multiple surgical fluid drainage under general anaesthetic, however, the issue did not resolved.Additional information has been requested but has not been made available as of the date of this report.
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Per the clinic, the device was explanted on (b)(6) 2024, and there are no plans to reimplant the patient with a new device as of the date of this report.Device analysis report attached.This report is submitted on may 15, 2024.
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