BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507001 |
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 07/01/2013 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a solyx sis system was implanted during cystoscopy, vaginal sling placement procedures performed on (b)(6) 2013, to treat a patient with female stress urinary incontinence.There were no patient complications during the implant procedure.The patient was taken out of position, awakened, and sent to the recovery room in good condition, having tolerated the procedure well.As reported by the patient's attorney, the patient experienced an unspecified injury.
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2013, implant date, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) (b)(4).
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