Date of event was approximated to (b)(6) 2015, implant date, as no event date was reported.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a xenform was implanted into the patient during sacrospinous ligament fixation and xenform placement procedures performed on (b)(6) 2015 to treat prolapse.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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