The exact date of the event is unknown.The provided event date, (b)(6) 2022, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2022.The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a problem 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 spaceoar was implanted during a spaceoar placement procedure performed on an unknown date.After the spaceoar placement procedure, magnetic resonance imaging (mri) for planning was performed.The images were reviewed and a rectal wall injection at the apex was noted.The patient was asymptomatic.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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