BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068503001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/08/2012 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: the exact event onset date is unknown.The provided event date of february 8, 2012 was chosen as a best estimate based on the date of the mesh was implanted.This event was reported to boston scientific corporation legal by the patient's legal representation.(b)(6).(b)(4).
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Event Description
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It was reported to boston scientific corporation that a lynx system was implanted during a lynx mid-urethral sling and cystoscopy procedures for the preoperative and postoperative diagnoses of female stress incontinence performed on (b)(6) 2012.Clinical history indicated that the (b)(6) female patient had a positive bonney test; urodynamic studies showed a hypotonic bladder with a stopping and starting stream, very poor flow, but actually complete emptying of the bladder.As reported by the patient's attorney, the patient has experienced an unspecified injury.
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