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
Incontinence (1928); Pain (1994); Constipation (3274); Dyspareunia (4505)
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Event Date 11/13/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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 implant was implanted into the patient on (b)(6) 2016.Obtryx implant was also implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Device 1 of 2.Patient symptoms include: pelvic pain; pain inter; diff bowel; rec incont; surgical interventions: on an unspecified date the patient underwent further surgery regarding the obtryx implant under general anesthesia for the following purpose: urine problems waiting for surgery date.Should be (b)(6).
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