The reported adverse is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.The patient chose to remove the implant magnet for personal reasons.Elective removal of an implant magnet is a procedure which requires medical/surgical intervention.This report is submitted on april 21, 2022.
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