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 (b)(6) 2020.Reportedly, the procedure was done under local anesthesia.According to the complainant, magnetic resonance imaging (mri) was performed and it showed less than 25% of the gel in the rectal wall.The patient also experienced discomfort and pain in the groin area and was treated with pain medication.The patient is reported to be doing better and will receive planned radiation therapy.
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