MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068503000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Dyspareunia (4505); Skin Inflammation/ Irritation (4545)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of september 17, 2018, was chosen as a best estimate based on the date of the mesh was implanted.Blocks d4, h4: the suspect device lot number is unknown; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2330- pain e1405 - dyspareunia.E2006 - mesh exposure.The following imdrf impact code capture the reportable event of: f1905 - vaginal mesh removal.
Event or Problem Description
It was reported that the patient underwent a suburethral sling procedure where a lynx system was implanted.After the procedure, cystoscopy evaluation showed no trauma to the bladder.On (b)(6) 2024, the patient was diagnosed with extrusion and dyspareunia.She experienced pain and irritation at the anterior vaginal wall.Cystoscopic exam was normal with no urethral or bladder erosion.Proper retraction was used to identify the mesh exposure and confirmed that there was no other mesh exposure other than the left vaginal fornix lateral to the urethra where the lateral flap would have been, which was 5 mm by 3 mm.The mesh that was embedded into the vaginal tissue was cut and was copiously irrigated.The vaginal flaps were healthy and sufficient to cover the defect, and no mesh was at the edges of the flaps.The flaps appeared healthy.The vagina was copiously irrigated once again, and the closed wound was hemostatic.She was to use topical vaginal estrogen for 6 weeks and follow-up for an exam in two weeks.

• Brand Name: LYNX SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19819123
• Report Number: 2124215-2024-44009
• Device Sequence Number: 8891764
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female