BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number 850-700 |
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); Dyspareunia (4505)
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Event Date 10/20/2011 |
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 solyx was implanted into the patient on (b)(6) 2011.The patient experienced non-surgical treatment.Patient symptoms include: vaginal pain; pelvic pain; pain inter; off vag dis; diff bowel; rec incont; aggrav incont; oth pain: naval and down to pelvic area.Nonsurgical treatments: the patient was treated with pain medication: panadol, nurofen, panadine fotre for the treatment of: when required for pain.The patient was treated with other medication (please specify): antibiotics (very strong) - keflex for the treatment of: urinary tract infections.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence.The patient was treated with other (please specify) for the treatment of: bladder, urinary tract stuff.
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