Note: this report pertains to one of two devices implanted during the same procedure.Refer to manufacturer report #3005099803-2022-07681 for the other associated device information.It was reported to boston scientific corporation that the patient was diagnosed with chronic pelvic pain, low back pain, large fibroid uterus, dysmenorrhea unresponsive to medical therapy, stress incontinence and grade 4 cystocele.On (b)(6) 2009, the patient was implanted with a solyx sis system and a pinnacle pelvic floor repair kits during laparoscopically-assisted vaginal hysterectomy, anterior vaginal repair and apical suspension using pinnacle system, and bladder sling with solyx system with diagnostic cystoscopy procedures.The procedure was completed with no patient complications.As reported by the patient's attorney, the patient has experienced an unspecified injury.
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