BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Urinary Incontinence (4572)
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Event Date 08/25/2010 |
Event Type
Injury
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Implant surgeon for xenform device: dr.(b)(6).Explant surgeon: dr.(b)(6).Block h6: imdrf patient codes e2330, e2311 and e1310 capture the reportable events of pain, discomfort and urinary tract infection.Imdrf impact code f1903 captures the reportable event of mesh appeared to be resected in its entirety.
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Event Description
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Note: this manufacturer report pertains to the second of three devices used during the same procedure.It was reported to boston scientific corporation that a pinnacle pelvic floor repair kits was implanted into the patient during a anterior repair with graft + vaginal sacral colpopexy + mid - urethral solyx sling procedure performed on (b)(6) 2010 for the treatment of stress urinary incontinence, leak point pressure 100cm, grade 2 - 3 cystocele with incomplete vaginal vault prolapse.Findings stated the patient had cystocele with hypermobile urethra.The operation was completed with no complications.The patient was awakened and taken to the recovery room in stable condition.The patient claimed that since the mesh placement, she had problems with recurring urinary tract infections as well as persistent incontinence, pelvic pain and discomfort.On (b)(6) 2015, the patient underwent surgical removal of vaginal mesh with anterior repair and cystoscopy.During the procedure, the mesh was split down the middle and then slowly dissected off both sides, it came off in two pieces and appeared to be resected in its entirety.The patient was awoken and brought to the recovery room in stable condition.
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