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 lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e233605 captures the reportable event of septic shock.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f0801 captures the reportable event of intensive care.
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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 sheath set were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2016.The patient experienced septic shock and was admitted to the intensive care unit (icu) and treated with intravenous (iv) antibiotics.In the physician's assessment the event was not related to the imager ii, percutaneous access needle 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 but was causally related to the procedure.
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