Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a right percutaneous nephrolithotomy procedure performed in (b)(6) 2019.The patient experienced acute kidney injury (aki) and obstruction.The patient had to be readmitted and was given antibiotics.
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Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2019.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient codes e130501 and e2328 capture the reportable event of acute kidney injury and obstruction.Imdrf impact codes f08 and f2303 capture the reportable event of readmission and medication.
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