It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a lithovue flexscope was used during a cystolitholapaxy/cystolithotripsy, cystourethroscopy with left ureteral stent placement, cystourethroscopy with left ureteral stent removal, left ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2017.During the procedure, the patient experienced arrhythmia.The patient was hospitalized and medication was required.
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The complainant was unable to provide the device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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