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); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 09/16/2016 |
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 solyx was implanted on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perin pain; thi pain; oth pain (hip and knee pain); inab inter; diff bowel; rec incont; aggrav incont; damage; psych.Surgical interventions: on (b)(6) 2020 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: cystoscopy.Nonsurgical treatments: on (b)(6) 2016 the patient commenced pain medication: panadol osteo for the treatment of: pain relief.Treatment duration: 5 years.On (b)(6) 2016 the patient commenced other medication (please specify): voltaren for the treatment of: relief from back pain and hips, used as needed.Treatment duration: 5 years.
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