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
Pain (1994); Abnormal Vaginal Discharge (2123); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
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Event Date 01/01/2015 |
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 solyx was implanted into the patient on (b)(6) 2011.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; groin pain; pain inter; off vag dis; psych.Nonsurgical treatments: on (b)(6) 2001 the patient commenced pain medication: trammel for the treatment of: for arthritis, pain relief.Treatment duration: 20 years.On (b)(6) 2015 the patient commenced psychological medication: lexapro for the treatment of: depression.Treatment duration: 5-6 years.On (b)(6) 2007 the patient commenced other medication (please specify): antibiotics.Treatment duration: as needed.
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Search Alerts/Recalls
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