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 Problem
Insufficient Information (4580)
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Event Date 06/09/2011 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a pinnacle pelvic floor repair kit was used during a bilateral sacrospinous ligament fixation, paravaginal defect repair with mesh and cystoscopy procedures performed on (b)(6) 2011 to treat a patient with paravaginal defect and vaginal vault prolapse.The patient was awakened and transferred to the recovery room in stable condition.There were no patient complications reported at the conclusion of the procedure.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 was approximated to (b)(6) 2011, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.
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Search Alerts/Recalls
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