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 vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2022.After the placement procedure in the recovery room, the patient complained of pain and nausea.The patient was rushed to the emergency room.Patient admitted to hospital beyond the standard of care.No information was provided on the patient's recovery status.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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