BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068503000 |
Device Problem
Defective Device (2588)
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Patient Problems
Erosion (1750); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pain (1994); Urinary Retention (2119); Hematuria (2558); Dysuria (2684)
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Event Date 11/19/2015 |
Event Type
Injury
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Manufacturer Narrative
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Age at the time of event: (b)(6).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The mesh excision surgeon is : dr.(b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem 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 lynx suprapubic mid-urethral sling system was implanted into the patient during a anterior/posterior colporrhaphy + lynx mid urethral sling placement procedure performed on (b)(6) 2015 for the treatment of symptomatic cystocele and rectocele, mixed incontinence (urge/stress).On (b)(6) 2015, the day after the implant, the patient experienced minimal vaginal bleeding and unable to urinate after the foley was removed.Urine retention was notified and the patient reports sharp pain at foley site and vaginal pressure.The patient was given percocet for pain.On (b)(6) 2019, the patient visited hospital due to gross hematuria, urethral erosion and hypertension.The patient began to notice gross hematuria and discomfort feeling with urination.Describes as scratchy.The patient had exam and cystoscopy revealing mesh migrating through urethra.The patient then underwent surgery for mesh excision and confirmed the presence of urethral erosion into the mid and proximal urethra.The mesh involved the lower half of the mid/proximal urethra, and this had to be resected in order to excise the mesh.A 6cm incision was made over the left labia.A 2cm x 6cm martius flap was dissected out.This was tunneled under the vaginal mucosa to the area of the urethral repair.There were no complications reported and the condition of the patient was reported to be stable.Consequently, the patient was advised to start taking medications of ciprofloxacin hci 500g, 1 tablet by mouth twice daily and ketorolac 10mg, 1 tablet by mouth every 6 hours as needed for up to 9 doses.
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