BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Inflammation (1932); No Code Available (3191)
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Event Date 11/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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 a pinnacle pelvic floor repair kit was implanted into the patient for the treatment of vaginal vault prolapse during a procedure performed on (b)(6) 2011.As reported by the patient's attorney, the patient underwent a cystoscopy, bladder distention, injection of kenalog and intravesicular lead procedure on (b)(6) 2016 due to interstitial cystitis and urinary urgency.The pinnacle device was dissected and majority of the mesh was removed.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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