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); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430)
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Event Date 05/30/2012 |
Event Type
Injury
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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) 2012.Advantage implant was also implanted into the patient on (b)(6) 2012.The patient experienced complications and nonsurgical treatment.Device 1 of 2.Patient symptoms include: back pain; pelvic pain; thi pain; off vag dis; diff bowel; rec incont; aggrav incont; psych; oth pain: cramping (abdominal bowel, upper leg).
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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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Search Alerts/Recalls
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