BOSTON SCIENTIFIC - MARLBOROUGH PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number UNK558 |
Device Problem
Material Deformation (2976)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device is implanted and will not be returned for evaluation; 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 kits was used during a pelvic floor procedure.According to the complainant, post procedure, the patient experienced chronic pain and requested removal of the device.Reportedly, the device had been correctly situated, but the anterior mesh was contracted.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Manufacturer Narrative
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Upon review, the upn of the complaint device is actually unknown.However, it was reported to be a pinnacle mesh.
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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 pelvic floor procedure.According to the complainant, post procedure, the patient experienced chronic pain and requested removal of the device.Reportedly, the device had been correctly situated, but the anterior mesh was contracted.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Search Alerts/Recalls
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