Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2016.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf impact codes f0801 and f2303 captures the reportable events of admission in the intensive care unit (icu) and antibiotic treatment.
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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 were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2016.The patient experienced sepsis and was admitted to the intensive care unit (icu) wherein she was treated with antibiotics.In the physician's assessment the event was not related to the imager ii and 8/10 dilator sheath set but was causally related to the procedure.In the physician's assessment the event was probably related to the nephromax balloon and percutaneous access needle but was causally related to the procedure.
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