The exact date of the event is unknown.The provided event date, (b)(6) 2020, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2020.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr 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.According to the complainant, the patient experienced severe pain six weeks after the procedure.Prior to the spaceoar injection, fiducial markers were placed and brachy therapy was performed.The physician scoped the patient's urethra and it was clean.The patient was given steroids to cure the pain and magnetic resonance imaging (mri) was scheduled to be performed on (b)(6) 2020.Reportedly, the patient was feeling better.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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