BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number 831-705 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Dyspareunia (4505)
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Event Date 03/30/2011 |
Event Type
Injury
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Manufacturer Narrative
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Patient identifier: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.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 was implanted into the patient on (b)(6) 2011.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; inab inter.Nonsurgical treatments: on (b)(6) 2009 the patient commenced incontinence medication: antibotics for the treatment of: bladder infections.Treatment duration: 11 years.
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Manufacturer Narrative
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Patient identifier: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.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 was implanted into the patient on (b)(6) 2011.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; inab inter.Nonsurgical treatments: on (b)(6) 2009 the patient commenced incontinence medication: antibotics for the treatment of: bladder infections.Treatment duration: 11 years.
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