BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Date 05/19/2010 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2010 (implant date) as no event date was reported.This complaint was reported by the patient's lawyer.The device was implanted at (b)(6).(b)(4).The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an advantage system was implanted into the patient during a vaginal hysterectomy, anterior and posterior repairs, vaginal vault suspension and cystoscopy procedure performed on (b)(6) 2010.As reported by the patient's attorney, the patient experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Search Alerts/Recalls
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